Author: Gloria Cote

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Health

Trump Administration Handed on Probability to Safe Extra of Pfizer Vaccine

Trump Administration Passed on Chance to Secure More of Pfizer Vaccine

michael barbaro

Hey, it’s Michael. We know that 2020 has been a difficult year. But it’s also been a year of small victories, personal milestones, and moments of joy. If something good happened to you, we want to hear about it. So write us an email or better yet, send us a voice memo to thedaily@nytimes.com— that’s thedaily@nytimes.com— and tell us your story of good news this year, large or small. And thank you. From The New York Times, I’m Michael Barbaro. This is The Daily.

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Today: From the start of the pandemic, the Trump administration said it was committed to ordering and stockpiling enough vaccine to end the pandemic as quickly as possible. But new reporting from The Times raises questions about whether it has actually done that. I spoke with my colleague, Sharon LaFraniere.

It’s Thursday, December 10.

So Sharon, tell me about this tip that you got.

sharon lafraniere

So it was on Saturday. I think I was playing bridge on my phone with the robots, which is how we spend Saturday nights now, right?

michael barbaro

Right.

sharon lafraniere

And I got a call from another New York Times reporter, mutual friend of ours, saying, I have heard this about Pfizer. You need to call this guy. Here’s his name. Here’s his number. Tell him you know me. And so I called the guy, and basically the tip was that the administration had muffed a chance to buy more of Pfizer’s vaccine, and now it couldn’t get it until, like, the middle of next year.

michael barbaro

Hm, that’s a very big tip.

sharon lafraniere

It’s a big tip because Pfizer’s vaccine has been shown to be 95 percent effective, and it’s the first one out of the gate, right? The Brits are already inoculating people with it. The Americans want it. And if we somehow missed out a chance to get twice as many doses as we had locked in, that would be a big deal.

michael barbaro

And I wonder what you thought when you heard this tip. I mean, it’s one of those things you hear, you’re sort of like, wait, could that be right?

sharon lafraniere

My reaction was, if this is right, it’s a big story.

michael barbaro

Mhm. And so what did you do?

sharon lafraniere

So I called my editors and my colleagues and said, we need to chase this as hard as we can. And so all Sunday we were calling everybody, and we’re getting like, sorry, can’t help you on this. Or, I never heard about this. Or, try some other people. And then finally on Monday afternoon, early Monday afternoon, we’re able to confirm it, that in fact Pfizer had tried to get the US government to lock in a hundred million extra doses but the government had turned them down.

[music]michael barbaro

So Sharon, what did you find out was the thinking behind this decision— which feels like a real head-scratcher on paper— not buying extra doses of a very effective vaccine from Pfizer?

sharon lafraniere

So to answer that, we really have to go back to the start of the administration’s whole crash program to develop vaccines, all the way back to March when it starts this initiative called Operation Warp Speed and comes up with a strategy to develop vaccines in record-breaking time.

michael barbaro

Right.

sharon lafraniere

So the initial strategy was that the government would pick three different technologies. And each technology would be pursued by a pair of companies, so six companies all together— six horses. They actually called them horses. And the idea of having a pair of companies is if one company fails, then you’ve still got one company standing to go after that technology. But nobody had any idea which of those vaccine technologies would work. So the government’s strategy was, we’ll back all six, and we’re going to pay this money even before we know whether the vaccines work or not.

But Pfizer was alone among the group in saying, we don’t want your money. And there’s really three reasons for that. So the C.E.O., Albert Bourla, told us, number one, it doesn’t need the money. Number two, it doesn’t want the government oversight. I mean, he actually felt that having government oversight over the vaccine project would not speed them up but it would slow them down. And number three, he was fearful about getting involved in the whole political drama that was starting to unfold with the White House pressuring the health agencies to act in one way or another. He just wanted to stay out of the political fray. And he thought if he takes the money, the money will come with strings attached, and he doesn’t want to be dragged into this.

michael barbaro

Got it. So what exactly is the arrangement with Pfizer? Because it sounds very different from the other five. What’s the eventual terms of it?

sharon lafraniere

So the contract called for Pfizer to deliver a hundred million doses to the U.S. government at a cost of $19.50 per dose by the end of the first quarter of 2021, but the U.S. government didn’t pay any money up front. In other words, only if this vaccine clears all the hurdles, gets approved by the F.D.A., and Pfizer’s able to manufacture it— only in that case will the US government have to actually pay the bill.

michael barbaro

Hm. So in some ways, this arrangement with Pfizer is better for the U.S. government than its arrangement with the five other companies. Doesn’t have to put any money down, and it seems like Pfizer is assuming most, if not all, of the risk.

sharon lafraniere

Exactly.

michael barbaro

This is a very good deal if you’re the United States government.

sharon lafraniere

Right. You get to lock in a hundred million doses, and you don’t have to pay up front.

michael barbaro

And so the U.S. takes that deal.

sharon lafraniere

Right.

michael barbaro

And when exactly was this?

sharon lafraniere

So the contract is signed in late July. But even at that time, we’re told, Pfizer is asking Operation Warp Speed officials, don’t you want more? Like, don’t you want to lock in an extra 100 million doses or 200 million doses? Because you don’t have to pay for them unless it works. And the answer was, no, we’re hedging our bets. We’ve got six candidates here. We’re not playing favorites among any of them. And Pfizer’s saying basically, yeah, but with us, it’s a free bet. But the government is saying, no, we’re sticking with our strategy. They don’t want to bet too heavily on any one of the six, even if the bet is free.

michael barbaro

And Sharon, as the U.S. government is turning down this offer from Pfizer, what does it actually know about Pfizer’s vaccine and how effective it may actually be?

sharon lafraniere

Well, remember this is July, and at this point, the government really doesn’t know very much, if anything, about which of these vaccines is going to work. But as time went on, it looks like suddenly that Pfizer is going to be the first over the finish line. But the problem is, a lot of other countries were also getting interested in Pfizer’s vaccine. They have a vaccine that is attracting so much attention that their executives are getting messages over LinkedIn from other countries, like, we want some. Can we lock this in?

And in early October, the U.S. government also gets interested in some extra doses and talks resume. But it’s no longer the same situation, because while the U.S. was hesitating, other countries were moving in. So in October, they don’t actually come to any agreement on a second contract because the U.S. is like, we need it sooner than it sounds like you’re delivering it. Or, you’re not promising us that we’re going to get it in time. Anyway, the talks are inconclusive. And then comes the big day of November 8.

archived recording

This is CNN breaking news. Pharmaceutical giant Pfizer reportedly making an enormous breakthrough with its Covid-19 vaccine, announcing today—

sharon lafraniere

Pfizer gets the interim results of its clinical trials.

archived recording

Pharmaceutical giant Pfizer just announced moments ago that its coronavirus vaccine is 95 percent effective. 95 percent effective— 95 percent effective, and they say with no serious side effects.

sharon lafraniere

And they are amazing.

archived recording

Pfizer’s C.E.O. is calling it, quote, “the greatest medical advancement in the last 100 years.” We will speak with—

michael barbaro

I remember that, Sharon. The results were stunning. And it suggested that this vaccine was going to be a blockbuster. But the U.S. still hasn’t ordered extra doses at this point?

sharon lafraniere

Right. And according to Scott Gottlieb, who is a member of Pfizer’s board and the former commissioner of the Food and Drug Administration, Pfizer was still offering— after the results came out— more doses, but the U.S. did not seal a deal then.

michael barbaro

Hm. So the Trump administration, the U.S. government, having missed this first chance back in July to lock in this deal for extra doses of this vaccine at no cost, is then told in October, and it sounds like even in November, we can’t offer you the exact same timeline. I mean, because months have gone by here. We’ve gotten other orders. And so as a result, despite how promising this vaccine turns out to be, the U.S. still decides not to order more. I just want to be clear.

sharon lafraniere

That seems to be the situation, yes. And then on November 11, which is basically two days after Pfizer has announced these amazing results, it announces that it has a deal to sell 200 million doses to the European Union. That was a contract that had been in negotiation for weeks and weeks. Nonetheless, the European Union has locked in 200 million doses, and the U.S. has locked in a hundred million doses.

michael barbaro

So it very much looks like the European Union got 200 million doses of the vaccine that could have gone to the United States if the United States had wanted them.

sharon lafraniere

Yes, that’s what it looks like.

michael barbaro

Sharon, do we know who exactly in the U.S. government made this decision repeatedly not to buy these vaccines?

sharon lafraniere

We’re not sure. We know that Pfizer was dealing with the guy who is the scientific leader of Operation Warp Speed. His name is Dr. Moncef Slaoui. But whether Dr. Slaoui was the one who was the final decision-maker or it was Alex Azar, the Health and Human Services secretary, or whether the White House was involved or not, we really don’t know now.

michael barbaro

So Sharon, if you could summarize it, what are the consequences of how the U.S. has approached these offers from Pfizer?

sharon lafraniere

So the consequence is that the U.S. might have to wait longer for as much supply of the Pfizer vaccine as it wants and needs. Because the state of play is that Pfizer is right on the brink of getting emergency approval from the Food and Drug Administration. It’s going to be the first vaccine to get that in the U.S. And the US government has locked in a commitment for a hundred million doses, enough to cover 50 million people, and it wants more. But it looks very unlikely that it can get it as soon as it wants it.

michael barbaro

So how much time have we lost here when it comes to the Pfizer vaccine orders that we never placed?

sharon lafraniere

So what we’re being told is that the U.S. government has now asked Pfizer for a hundred million doses, and they want them starting in March. But Pfizer is saying, sorry, we cannot guarantee you these doses until June. So if that’s how it all plays out, the way it’s looking now, then we would have lost three months.

michael barbaro

Three months. Three months of not having tens of millions of doses that the U.S. could have had.

sharon lafraniere

If it works out that way, that would be three months in which the U.S. is waiting for a Pfizer vaccine because it didn’t lock in more doses earlier.

[music]michael barbaro

We’ll be right back.

Sharon, having made this decision, which in retrospect feels like a pretty strange and bad decision, what does the United States now do to correct for this? Could we just beg Pfizer to make extra doses for us?

sharon lafraniere

No, because it’s not that Pfizer is not willing to make more doses for Americans. It’s making every dose that it can possibly make right now. It doesn’t have empty factories somewhere where it can go in and just flip on the lights and suddenly there’s lots more doses. It has legal commitments to other countries to provide supply. And those countries want it too. It’s not a matter of begging Pfizer to make more. If they had more to give the Americans, they would give it to them. Pfizer has a very big motivation to put the U.S. first, because Pfizer, number one, it’s an American company.

michael barbaro

Right.

sharon lafraniere

Number two, most of its customers are in the U.S. They do not want to be in this situation where their customers think, what, you’re making deals to save the lives of Europeans and you’re leaving Americans here waiting for lifesaving vaccines? They don’t want a consumer backlash.

michael barbaro

Could the U.S.— and here I’m just kind of exhausting American curiosity. Could the U.S. kind of forcefully take vaccine from Pfizer if it wanted to be extremely nationalistic and say, nobody gets doses outside the U.S. before we get doses?

sharon lafraniere

I mean, that seems highly unlikely that the U.S. government is going to move into Pfizer’s factories and rip up all its contracts and commandeer its doses. President Trump signed an executive order this week saying that Americans would get vaccine supplies first, but it seems pretty meaningless. It’s hard to imagine what the government could do to force Pfizer to redirect vaccine that it’s committed to other countries to Americans. I mean, some people have speculated, maybe could Pfizer team up with another pharmaceutical company like Merck? And then could there be some kind of partnership there that would allow it to increase production? But it cannot itself, now, just turn on a dime and create more production.

michael barbaro

OK, so with no great options for securing more doses from Pfizer right away, what can the U.S. do instead? How do we make up for those missing doses? I have to imagine the answer lies with these other companies that the U.S. has invested in.

sharon lafraniere

Exactly. Moderna is right behind Pfizer with a very similar vaccine that is proven to be equally effective. It’s likely to win emergency approval from the F.D.A. maybe a week after Pfizer does later this month. It too has committed to provide the U.S. with a hundred million doses. Like Pfizer, it has to deliver those doses by the end of the first quarter of next year. It’s easier to store than Pfizer’s, and it might be easier to ship. It’s a much smaller company than Pfizer, right? It spent 10 years without bringing a product successfully to market, but it’s done extremely well with this vaccine. So there’s the Moderna option.

michael barbaro

So if I’m keeping count correctly, 50 million Americans would be inoculated through Pfizer’s vaccine.

sharon lafraniere

Right.

michael barbaro

50 million Americans would be inoculated through Moderna’s vaccine. That still leaves a lot of Americans. So what about these other companies?

sharon lafraniere

So of the other four companies, two of them are sort of off the table right now because they haven’t even started their phase 3 clinical trials. Another one, AstraZeneca, which has developed its vaccine with University of Oxford researchers, is about halfway enrolled in its clinical trial here. And there are some questions about its data, its transparency. It’s had somewhat rocky relations with the F.D.A. And its early results have shown basically that for the full two-dose regime, it was shown to be about 62 percent effective. So you have to ask yourself, are Americans going to want to take a vaccine that’s 62 percent effective when they have two vaccines out there that are 95 percent effective?

michael barbaro

Right. And I think we all know the answer to that is probably no, not really. So it’s really kind of “Moderna and Pfizer or bust” for the moment.

sharon lafraniere

Well, there’s also Johnson & Johnson, and it expects to have clinical trial results early next year. But we don’t know if that vaccine worked or not. If it works, that gives us a third. But at the moment, the U.S. government has got, as you said, commitments for 200 million doses, which will cover a hundred million Americans. And the question is, what is going to happen at the end of March? Are we going to fall off some kind of vaccine cliff here? Or, is there going to be an interval in which people are not being vaccinated? Or, are there going to be enough doses to fill in the gap?

michael barbaro

Mhm. So what happens if we reach and go over a vaccine cliff?

sharon lafraniere

So the worst case scenario is that there is an interval in which Americans are waiting and that there’s some sort of break in the inoculation program. But we don’t know that’s true. We don’t know for sure that that’s going to happen. Moderna could fill in some of the gap. And at the moment, all we can say is that it kind of raises the anxiety level that we have two successful vaccines, and so far, we have not locked in enough doses to cover more than a hundred million Americans.

michael barbaro

Right. So no matter how you slice it, the chances of us going over a vaccine cliff, of suddenly having some period of some unknown duration where Americans are not being inoculated, which is not what we want, the chances of that are higher— correct me if I’m wrong— because the United States did not order more of these doses from Pfizer. Is that right?

sharon lafraniere

I think that’s right. The administration says that is not going to happen. We’re not going over this cliff. That there’s going to be enough vaccine for everybody, that there are more supplies coming in, that there are negotiations going all the time. That they feel confident that they are going to have enough vaccine doses for every single American who wants it by spring or the middle of next year.

michael barbaro

Mhm. But the government can’t assure that.

sharon lafraniere

Not yet.

michael barbaro

Sharon, it feels like the consequence of what the U.S. government, of what the Trump administration has done here, is time. You said that the decision-making here may have delayed this acquisition of vaccines by something like three months. Time is a very precious resource in this pandemic. Time is how we measure the number of people who get exposed to this virus, who get infected by it, who get killed by it. And so every single day matters. And so three months, 90 days, that really matters, right? It means more people are likely to get this virus and potentially to die from it.

sharon lafraniere

I mean, I really, really hope that’s not so. Well, the whole story is such a roller coaster, right? We get these amazing results from Pfizer and Moderna, and everybody is just ecstatic. And then we learn, whoa, we don’t have enough. And are we going to get enough? And everybody would feel much more comfortable if we had all these doses in the bank.

michael barbaro

Mhm. I mean, what makes this feel especially confounding is that vaccines have been the U.S. government’s approach to this pandemic, right? I mean, the Trump administration has not issued national lockdowns. It has not issued a national mask mandate. What it has said is that what will get us out of this pandemic is a vaccine. We are going all in on vaccines. It’s pretty much our only solution to the pandemic. So to have not done everything conceivably possible to get as many doses of the vaccine as we could, knowing that this is our solution, just becomes extremely hard to understand or explain.

sharon lafraniere

So in hindsight, some administration officials will say privately they wish that they had locked in more doses earlier. That this has exposed a kind of flaw in their strategy. And that now they’re scrambling to figure out how can they compensate for it. And that is weighing heavily on them.

michael barbaro

Sharon, thank you very much. We appreciate it.

sharon lafraniere

Thank you, Michael.

[music]michael barbaro

On Wednesday afternoon, Canada became the latest country to approve Pfizer’s vaccine, meaning that its citizens may start to receive it beginning next week. A few hours later, The Times reported that the United States had passed a grim new milestone on Wednesday— 3,000 deaths from the coronavirus in a single day. We’ll be right back.

[music]

Here’s what else you need to know today:

archived recording

No company should have this much unchecked power over our personal information and our social interactions.

michael barbaro

In a lawsuit filed on Wednesday, the Federal Trade Commission and attorneys general from 48 states called for breaking up Facebook.

archived recording

And that’s why we are taking action today and standing up for the millions of consumers and many small businesses that have been harmed by Facebook’s illegal behavior.

michael barbaro

The lawsuit accused the company of purchasing its rivals, including Instagram and WhatsApp, in order to eliminate potential competition and in the process, acting as an unlawful monopoly. In response, Facebook said that it would vigorously defend itself during what is expected to be a long and expensive legal battle.

[music]

That’s it for The Daily. I’m Michael Barbaro. See you tomorrow.

Categories
Business

Gov. Greg Abbott on Oracle, corporations transferring headquarters to Texas

Gov. Greg Abbott on Oracle, companies moving headquarters to Texas

Texas governor Greg Abbott told CNBC on Friday that the number of companies relocating their headquarters to the Lone Star State has accelerated in part due to the coronavirus pandemic.

The Republican governor’s comments came shortly after it was reported that software giant Oracle was moving its corporate headquarters from Redwood City, California, in Silicon Valley, to Austin, Texas. Hewlett Packard Enterprise announced earlier this month that it is moving its headquarters from San Jose, California to Houston. Real estate giant CBRE officially relocated its headquarters from Los Angeles to Dallas in early fall.

“I’ve been on the phone with CEOs across the country weekly, and it’s not just California,” Abbott told Fast Money, referring to his meeting with Nasdaq officials last month. “We’re working across the board because the times of Covid revealed a lot. They revealed … that, for example, you really don’t have to be in Manhattan to be involved in the trading business or the investment business.”

In addition to the pandemic demonstrating the feasibility of more widespread remote working, Abbott said there are other characteristics that are pulling businesses to Texas. “Business costs mean a lot. No income tax means a lot, but the freedom to operate without the strict hand of regulation also means a lot,” he said.

“This has become an absolute tidal wave,” added Abbott, while many companies like Oracle were in Texas prior to their official announcements. “They are looking for a state that gives them the independence, the autonomy and the freedom to set their own course.”

Abbott also cited Texas’s relationship with Elon Musk, the executive director of electric vehicle maker Tesla and SpaceX, as evidence of the state’s growing appeal to business leaders.

Musk personally moved to Texas from California, and earlier this year Tesla announced that it had selected a location near Austin to build its next U.S. factory. SpaceX also has a growing facility in Boca Chica, Texas, on the Gulf Coast. “Elon is delighted to be here,” said Abbott, adding that the two men “talk to each other practically weekly.”

Categories
Business

A High Home Democrat Prods Biden to Reopen E.U. Commerce Talks

A Top House Democrat Prods Biden to Reopen E.U. Trade Talks

WASHINGTON – The chairman of the powerful House Ways and Means Committee called on the new administration to renew trade negotiations with the European Union and contradicted President-elect Joseph R. Biden Jr.’s pledge to postpone new trade talks until the U.S. has made major domestic deals Investments made.

The statement by Massachusetts Democrat Richard E. Neal on Friday raises the question of whether congressional pressure could induce the Biden administration to become more aggressive in trade negotiations with close allies.

Mr Biden downplayed expectations of new trade negotiations early in his tenure, saying he would first take control of the pandemic and make significant investments in American industries such as energy, biotechnology and artificial intelligence.

“I’m not going to sign a new trade deal with anyone until we’ve made big investments here in our homes and in our workers,” Biden said in an interview with the New York Times last week.

However, since the opposition in Congress would be one of the main obstacles to a new trade deal, the support of key Democrats could be a strong motivation for starting talks.

In an interview, Mr Neal suggested that reaching a trade deal with the European Union would help tackle the increasing economic threat posed by China, which has used hefty subsidies, state-owned companies and other practices to dominate the industry and trade rules long to question embraced in the west.

Mr. Neal called Mr. Biden’s approach “good and fair” but argued that continuing the EU trade negotiations “is part of a foreign policy challenge related to China’s expansionist activities”.

“I think we should prepare now to do justice to China’s aggressive nature in the world,” he added.

Mr Biden would need the help of Mr Neal and others to cement such a deal. The so-called Trade Promotion Agency, a law that lays down guidelines for the executive branch to negotiate trade deals and streamline the approval process, expires in July. Business then submitted to Congress could find a more difficult path to ratification. It is not yet clear whether the Biden administration will petition Congress to renew authority.

Despite deep historical ties, the United States and Europe have not always had an easy trading relationship. Governments have fought over tariffs, farm subsidies, and food safety standards for decades, and efforts to achieve a comprehensive trade pact under both the Obama and Trump administrations have ultimately ceased.

But Mr Biden has spoken many times about the importance of strengthening American alliances, and he and his advisors have been eager to eradicate ties with Europe that have been weighed down by President Trump’s confrontational approach to trade. They also see many similarities with the European Union on issues such as climate change, labor standards and consumer protection, as well as against China’s growing geopolitical power and trade practices.

Economy & Economy

Updated

Apr 11, 2020 at 12:33 am ET

Both governments seem eager to make progress on trade issues that have stalled under the Trump administration, including Spats over subsidies to the aircraft industry and plans by European countries to tax American tech giants.

These discussions would be chaired by Mr Biden’s sales representative, Katherine Tai, whom the president-elect presented as his candidate for office on Friday. Ms. Tai is an associate of Mr. Neal as Chief Commercial Attorney on the Ways and Means Committee.

Mr. Neal declined to enter into discussions with Ms. Tai about trade deals with the European Union, but said, “I think we largely agree on the nature of the challenge.”

Mr Neal referred to the US-Mexico-Canada agreement as a “blueprint” for new trade pacts. The deal, the successor to the North American Free Trade Agreement, was negotiated by Mr. Trump and revised by Congressional Democrats, including Mr. Neal and Ms. Tai, before it went into effect this year.

“What we’ve been able to do with USMCA on the environment, labor standards and enforcement – I think we have some momentum,” said Neal. He said he was continuing to work to raise support for using a European trade agreement to counter China’s influence around the world.

In his statement on Friday, Mr Neal said a trade deal with the European Union was a “strategically sound choice” as the United States sought to compete economically with China and rebuild its economy after the pandemic recession.

He called on the Biden government to work with allies in Europe and elsewhere to “formulate a strategic, far-reaching, forward-looking and robust package of programs and investments to defend against anti-competitive, anti-democratic influences in Chinese politics.”

Categories
Health

Black well being leaders attempt to construct belief within the Covid vaccine amongst African People

Black health leaders try to build trust in the Covid vaccine among African Americans

A researcher works at a laboratory operated by Moderna Inc that said in an undated still image from a video on November 16, 2020 that his experimental vaccine was 94.5% effective in preventing COVID-19, based on interim data from one late clinical trial.

Modern | via Reuters

Dr. Lou Edje participated in the Moderna vaccine study in her healthcare system in Cincinnati, Ohio after three of her relatives died from the coronavirus earlier this year. This led her to do more to instill trust in her community and get vaccinated.

“I felt like I might be able to make a believable impact on the patients I care for every day who look just like me,” said Edje, Black and Associate Dean for Medical Education at the University of Cincinnati College of Medicine.

Although she wasn’t told if she received the actual vaccine during the trial, she had a slight swelling in her arm after the booster shot – which leads her to believe she did. This helps when patients ask what to expect.

“Some of the side effects were a little more robust the second time around, so I’m trying to tell them exactly what I went through,” she explained.

It can take months before the public are vaccinated with new vaccines once they are approved. The Food and Drug Administration is expected to quickly clear Pfizer’s vaccine for emergency use after an advisory panel overwhelmingly approved the shots on Thursday. Starting doses have been set for frontline health workers and the elderly in long-term care facilities such as nursing homes.

Still, African-American health professionals and community health groups across the country have already started reaching out in black communities hard hit by the coronavirus. According to a poll by Pew Research last month, seven out of ten African Americans know someone who was hospitalized or died of Covid. However, there is great skepticism about vaccines. Only 42% of blacks surveyed say they have been vaccinated, compared with more than 60% of Americans as a whole.

“They want to know, and have real reasons to trust. They want to know that the trial will be fair, that they are not guinea pigs for a system that is turned against them,” explained Dr. Reed Tuckson, co-founder of the Black Coalition Against Covid and former Washington, DC Commissioner for Health

The speed at which the Covid vaccine was being developed was one of the issues that many Americans have concerns about being in the first wave to get the shot. But for African Americans, the skepticism is also based in part on history. As part of the infamous Tuskegee study of syphilis, African American men were treated with placebo drugs instead of antibiotics, which they could cure, so officials could follow the disease over the years.

The Coalition on Covid has brought together major African American medical groups, including the National Medical Association and the National Black Nurses Association, as well as heads of four historically black medical schools, including Howard University and Morehouse College, to advocate for African American patients.

In the clinical arena, they have urged federal and local government officials to prioritize access for color communities where the prevalence of pre-existing conditions like high blood pressure and diabetes has increased people’s vulnerability to the virus.

“We shouldn’t let the proliferation of a life-saving vaccine worsen health inequalities. In fact, it should help narrow them down,” said Tuckson.

In terms of reach, they’ve held a number of informative town halls online with government leaders including Dr. Anthony Fauci, the country’s foremost infectious disease expert, to address specific concerns among African Americans.

They also work with community health groups, local churches, and stakeholders who can reach out to the grassroots personally from a place of trust.

“Fifty percent of one neighborhood must have the vaccine to burn out the virus in the other 50 percent,” explained Edje. “We really need to ensure that every neighborhood has some immunity so that we can make a global impact.”

The fact that it will take time for the public to gain access to the vaccine could prove to be a silver lining. Health officials say it will show people how the first wave of those who get the shot react, which can help fight skepticism and fear.

Categories
World News

White Home threatens to fireplace FDA chief until Covid vaccine OKed Friday: experiences

White House threatens to fire FDA chief unless Covid vaccine OKed Friday: reports

US President Donald Trump and Stephen Hahn, Director of the Food and Drug Administration, attend the daily meeting of the coronavirus task force at the White House in Washington, DC on April 24, 2020.

Drew Angerer | Getty Images

White House chief of staff, Mark Meadows, has urged the head of the Food and Drug Administration to resign if the agency does not clear Pfizer’s coronavirus vaccine for emergency use by the end of the day, the Washington Post reported on Friday.

The warning prompted FDA Commissioner Stephen Hahn and the agency to accelerate their schedule for the release of America’s first Covid-19 vaccine from Saturday morning to late Friday, according to the Post, citing anonymous sources.

The New York Times, Axios, and Reuters also reported that Meadows urged Hahn to resign if he wasn’t quick enough to remove the vaccine.

In a statement, Hahn called the Post’s report “an untrue account”.

“This is an untrue representation of the telephone conversation with the chief of staff,” Hahn told CNBC on Friday afternoon. “The FDA has been encouraged to continue working swiftly on Pfizer-BioNTech’s EEA request. The FDA is committed to swiftly granting this approval, as we noted in our statement this morning.”

The White House did not immediately respond to CNBC’s request for comment.

The reports come a day after a key FDA advisory body voted 17-4, with one abstention, to recommend the vaccine, which Pfizer partnered with BioNTech, for emergency approval. The FDA typically follows the recommendations of the Advisory Committee on Vaccines and Related Biological Products. After the overwhelming vote, the FDA should release the vaccine on Friday.

Hahn said earlier that day the agency was “working fast” to clear Pfizer’s emergency vaccine. “The agency has also notified the US Centers for Disease Control, Prevention and Operation Warp Speed ​​so they can implement their plans for timely vaccine distribution,” Hahn said in a joint statement with Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research.

Shortly after Hahn ’s remarks, President Donald Trump, who has repeatedly urged the FDA to speed up the vaccine development process, tweeted the agency,” Get the dam vaccines out NOW. “

“Stop playing and save lives !!!”

FDA approval would mark a record-breaking timeframe for a process that typically takes about a decade. The fastest vaccine development to date against mumps took more than four years and was licensed in 1967. Pfizer and BioNTech announced plans to develop a coronavirus vaccine in March and filed an emergency clearance application with the FDA in November.

An emergency permit, or EEA, is not the same as a full permit, which can typically take months. Pfizer has only submitted safety data for two months, but it typically takes the agency six months for full approval.

– CNBC’s Amanda Macias contributed to this report.

Categories
Business

New York Metropolis will shut indoor eating beginning Monday, Gov. Cuomo says

New York City will shut indoor dining starting Monday, Gov. Cuomo says

New York Governor Andrew Cuomo announced Friday that New York City restaurants will have to close indoor restaurants as new daily coronavirus cases across the state for the first time since spring and hospital stays in Covid-19 10,000 have dwarfed.

The Democratic governor said restaurants will continue to have al fresco dining areas and offer take-out and delivery from Monday. Cuomo warned earlier this week that the state could shut down indoor dining if the city’s hospitalization rate didn’t stabilize.

“You will see a bad December, a bad January. How bad is the question,” Cuomo said at a press conference.

He said the outbreak will not “end” until the vaccine is widely available, which could be June or September. “It’s a long six months between today and June,” he said.

Cuomo cited additional warnings from the Centers for Disease Control and Prevention, issued last week, warning of “exposures in non-essential indoor and overcrowded outdoor areas.” According to a slide presented at the briefing, they presented an “avoidable risk for all participants”.

“In New York City, you have taken the CDC caution when eating indoors, along with the rate of transmission and the density and crowding, which is a bad situation. New York City hospital stays have continued to increase,” Cuomo said.

The move marks a notable reversal of the state’s reopening plans as New York City returned to dining at 25% indoor capacity on September 30th. The restaurants in the Big Apple have had to stay afloat and eat-out by eating al fresco in recent months, even as falls declined in summer and early fall. Cuomo and New York Mayor Bill de Blasio postponed the return of indoor dining in early July as other states in the US reported worsening outbreaks.

However, the Empire State governor urged the schools to stay open, saying they were much safer. He said the rate of positivity, or the percentage of Covid-19 tests that came back positive, “tends to be lower” in schools compared to the surrounding community.

“My point is, if it is safer for the children to be in school, then you have the children in school. If it is safer for the teacher to be in school, then you have the teacher in school “said Cuomo.

The state is now concerned about what Cuomo calls “living room sprawl”. Almost 74% of new Covid-19 cases come from households and social gatherings, according to Cuomo. Restaurants and bars accounted for 1.43% of new cases, while gyms accounted for less than 1%.

“We may see the end of the Thanksgiving wave, if you will, but we are about to get into the Hanukkah wave and the Christmas tide and the Christmas week and the Kwanzaa wave and New Years Eve and New Years Anniversary,” Cuomo said, adding added that the health authorities hope for a “stabilization” by mid to late January.

Source: New York State

According to a CNBC analysis of data from the COVID Tracking Project, an independent volunteer organization started by journalists from The Atlantic, New York reports an average of around 4,653 people hospitalized with Covid-19. This corresponds to an increase of 30% compared to a week ago.

However, “the situation in the hospitals is better than in the past,” said Cuomo. Compared to the spring when the virus first swept through New York and overwhelmed its hospital systems, there are now 30% fewer people in the state’s intensive care units and 50% fewer people intubated, Cuomo said. The mean hospital stay has also fallen from 11 days in the spring to five days now.

New York expects 170,000 doses of Pfizer’s Covid-19 vaccine on Sunday or Monday, Cuomo said. The doses could be issued as emergency clearance by the U.S. Food and Drug Administration at any time after a key panel overwhelmingly approved the recordings Thursday night.

Another highly anticipated vaccine from Moderna could get the green light in the coming weeks. Cuomo said the state expects 346,000 doses of this vaccine by the week of December 21st.

“The vaccine is coming and we are ready to give it,” said Cuomo.

Categories
Politics

Senate Sends Navy Invoice to Trump’s Desk, Spurning His Veto Menace

Senate Sends Military Bill to Trump’s Desk, Spurning His Veto Threat

WASHINGTON – The Senate overwhelmingly passed a comprehensive military policy law on Friday to remove Confederate names from American military bases to clarify the measure for enactment and to keep them on President Trump’s desk despite his veto threats send.

The vote between 84 and 13 to pass the legislation reflected widespread support from both parties for the measure authorizing the payment of American troops and was intended to signal Mr Trump that lawmakers, including many Republicans, were determined to do the critical Passing the law, even if this may mean giving up the first right of veto of his presidency.

The margin exceeded the two-thirds majority required in both houses to force passage of the law on Mr Trump’s objections. The House also hit that threshold in passing the measure on Tuesday, increasing the prospect of a possible veto showdown in Mr Trump’s final weeks of office.

The scene that played out in the Senate on Friday underscored how the Republicans, who did not want to challenge the president on any other issue during his four-year term, were extraordinarily ready to break with Mr Trump over one of the party’s key orthodoxy – military strength project.

“I encourage all of us to do what we must to bring this bill to fruition,” said Senator James M. Inhofe, Republican of Oklahoma and Chairman of the Armed Forces Committee, to his colleagues in a speech from the ground. “There is no one in America who deserves more than our troops that are in danger, and we will make sure we are doing what is right for them.”

Thirteen senators, evenly spaced across party lines, voted against the bill, with Republicans supporting Mr Trump’s objections and Democrats chafing on the bill’s topline number. Three Senators, Lindsey Graham, Republican of South Carolina, Mike Rounds, Republican of South Dakota, and Kamala Harris, Democrat of California and vice president-elect, did not vote.

Congress has succeeded in passing the military law every year for 60 years. But Mr Trump has threatened to change that tradition, pledging to veto the legislation since the summer, even as his own party’s leaders privately pleaded with him to support it.

Mr Trump initially opposed a provision largely backed by lawmakers from both parties in both chambers that would strip the names of Confederate leaders from military bases. In the past few weeks his attention has shifted, demanding that the bill provide for an independent lifting of a legal shield for social media companies.

This demand, which was registered late in the legislative process, found little support from the legislators of both parties. They feel it is untenable to take an important, unrelated political move towards the defense law. They were hoping that strong voices in both chambers would convince Mr Trump to back off his threat of veto. However, so far the president has given no indication that he will do so.

The legislation includes a number of undisputed, bipartisan measures, including new benefits for tens of thousands of Vietnam-era veterans exposed to Agent Orange, a 3 percent increase in service member wages and an increase in remuneration for dangerous levies.

It would also take steps to slow or block Mr Trump’s planned withdrawal of American troops from Germany and Afghanistan, and it would make it difficult for the president to deploy military personnel on the southern border.

Legislation also directly addresses the racial justice protests sparked by the police killing black Americans, including George Floyd, this summer. All federal officials who enforce crowd control during protests and demonstrations would have to identify themselves and their authorities. And it includes the bipartisan move directing the Pentagon to begin renaming military bases named after Confederate leaders, a provision the Democrats fought to uphold.

If Mr. Trump were to enforce his threatened veto, the House would be the first to attempt an override.

Emily Cochrane contributes to the coverage.

Categories
Entertainment

FKA Twigs Sues Shia LaBeouf For Sexual Battery

LONDON, ENGLAND - FEBRUARY 18: (EDITORIAL USE ONLY) FKA Twigs attends the 2020 BRIT Awards at the O2 Arena on February 18, 2020 in London, England. (Photo by Jim Dyson / Redferns)

Singer FKA Twigs has filed a lawsuit against Pieces of a woman Star Shia LaBeouf, who claims the actor subjected her to “relentless abuse” including sexual battery, assault, and infliction of emotional stress. The New York Times The news was released on December 11 and revealed numerous examples of the alleged abuse listed in the lawsuit, including an incident in 2019 where LaBeouf reportedly attacked Twigs outside a gas station while on a road trip.

Both in the lawsuit and in an interview with The New York TimesTwigs, nee Tahliah Barnett, said her goal in the lawsuit against LaBeouf is to help other women and explain how abuse can happen to anyone, regardless of their socioeconomic status. “I want to be able to raise awareness of the tactics that abusers are using to control you and take your agency away,” Twigs said The New York Times. “What I went through with Shia was the worst I’ve ever been through in my entire life. I don’t think people would ever think it was going to happen to me. But I think that’s the thing. It can happen to everyone. “

“I don’t think people would ever think it would happen to me. But I think that’s the thing. It can happen to anyone.” – FKA branches

Twigs, who filed the lawsuit in the Los Angeles Superior Court, dated LaBeouf for a year after they met on the set of Honey boy The musician claims LaBeouf earned her trust in “excessive displays of affection” in the early stages of their relationship, before becoming abusive. She accuses the actor of knowingly inflicting a sexually transmitted disease on her, isolating her from her professional environment by convincing her to stay with him in Los Angeles, and manipulating her emotionally to cast doubt on her creative team. According to The New York TimesTwigs reported on an event in the spring of 2019 where she was packing to leave LaBeouf and he showed up unannounced. He “grabbed” her hard, picked her up, and locked her in another room, where he yelled at her. Your housekeeper is a sworn witness to this incident.

“The entire time I was with him I could have bought a business flight ticket to my four-story townhouse in Hackney,” she said The New York Times. She says she didn’t because “he got me so deep that the idea of ​​leaving him and coming to terms with me just seemed impossible.”

The New York Times reports that the lawsuit also listed previous examples of abuse, including allegations made by Karolyn Pho, a stylist who was previously dated with LaBeouf. She claims the actor pinned her to a bed while drunk and “hit her with the head so that she was bleeding”.

Although LaBeouf did not comment on the lawsuit, he sent two separate emails The New York Times on the allegations against him. In the first he wrote: “I am unable to tell anyone how my behavior made them feel. I have no excuses for my alcoholism or aggression, just rationalizations. I have looked at myself and everyone around me for years abused I am ashamed of this story and apologize for those I have hurt. There is nothing I can really say. “

When he became aware of the detailed allegations made by Twigs and Pho, he wrote again that “many of these allegations are not true,” but he owed women the opportunity to make their statements publicly and to take responsibility for these things done. “” I am not cured of my PTSD and alcoholism, “he wrote, explaining that he is a sober member of a recovery program,” but I am determined to do what I have to do to recover, and it I will forever feel sorry for “people I might have hurt along the way.”

Branches told The New York Times After seeing how expensive it can be to get out of abusive situations, she plans to donate a significant portion of the monetary damage to domestic violence charities.

Image source: Getty / Jim Dyson

Categories
Health

Australia Scraps Covid-19 Vaccine That Produced H.I.V. False Positives

Australia Scraps Covid-19 Vaccine That Produced H.I.V. False Positives

Australia on Friday canceled a roughly $ 750 million plan for a major contract for a locally developed coronavirus vaccine after vaccination resulted in false positive test results for HIV in some volunteers participating in an experimental study.

Of the dozen of coronavirus vaccines tested worldwide, the Australian one was the first to be abandoned. While the developers said the experimental vaccine was safe and effective, the false positives risked confidence in efforts to vaccinate the public.

Prime Minister Scott Morrison said Friday that his government would partially offset the loss of 51 million doses it planned to buy from the Australian consortium by increasing orders for vaccines from AstraZeneca and Novavax. The government has announced that it will start vaccinating citizens in March.

“We can’t have problems with trust,” he told reporters, “and now as a nation with a good portfolio of vaccines we are able to make those choices to best protect the Australian people.”

The Australian setback highlighted the missteps that can inevitably occur when scientists shorten the usual year-long process of vaccine development to a few months during a pandemic that killed more than 1.5 million people.

But just as the Australian scientists made their announcement, the fruits of this breed became clearer. The United States got one step closer to getting its first approval for a Covid-19 vaccine when a panel of experts advising the Food and Drug Administration endorsed a Pfizer vaccine that is already in use in the UK.

The problem with the Australian vaccine, developed by the University of Queensland and biotech company CSL, was related to the use of two fragments of a protein found in HIV

The protein was part of a molecular “clamp” that researchers placed on the spikes surrounding the coronavirus and allowed it to penetrate healthy cells. The bracket stabilizes the spikes and allows the immune system to respond more effectively to the vaccine.

Using the HIV protein did not pose a risk of infecting the volunteers with this virus, the researchers said. However, the clamp produced the production of antibodies that were detected by HIV testing at higher levels than scientists expected.

Because HIV tests couldn’t be quickly revised to take this into account, the researchers decided to stop developing the vaccine. The act could have created widespread fears among Australians that the vaccine could cause AIDS.

Early experiments on hamsters showed that the vaccine protected them from the coronavirus. When Phase 1 human trials began in July, the 216 volunteers were “fully informed about the possibility of a partial immune response” to the clamp, the University of Queensland and CSL said in a statement Friday.

Updated

Apr 11, 2020 at 1:26 am ET

The mistake, said John P. Moore, an immunologist at Weill Cornell Medical College in New York, was an “honest mistake” that cost money, not human life.

“I’m sure a lot of people are very embarrassed,” said Professor Moore. “It’s not great to be associated with a bug like this. But when you run at 90 mph, you sometimes trip. “

The coronavirus outbreak>

Things to know about testing

Confused by Coronavirus Testing Conditions? Let us help:

    • antibody: A protein produced by the immune system that can recognize and attach to certain types of viruses, bacteria or other invaders.
    • Antibody test / serology test: A test that detects antibodies specific to the coronavirus. About a week after the coronavirus infects the body, antibodies start appearing in the blood. Because antibodies take so long to develop, an antibody test cannot reliably diagnose an ongoing infection. However, it can identify people who have been exposed to the coronavirus in the past.
    • Antigen test: This test detects parts of coronavirus proteins called antigens. Antigen tests are quick and only take five minutes. However, they are less accurate than tests that detect genetic material from the virus.
    • Coronavirus: Any virus that belongs to the Orthocoronavirinae virus family. The coronavirus that causes Covid-19 is known as SARS-CoV-2.
    • Covid19: The disease caused by the new coronavirus. The name stands for Coronavirus Disease 2019.
    • Isolation and quarantine: Isolation is separating people who know they have a contagious disease from those who are not sick. Quarantine refers to restricting the movement of people who have been exposed to a virus.
    • Nasopharyngeal smear: A long, flexible stick with a soft swab that is inserted deep into the nose to collect samples from the space where the nasal cavity meets the throat. Samples for coronavirus tests can also be obtained with swabs that do not go as deep into the nose – sometimes called nasal swabs – or with mouth or throat swabs.
    • Polymerase chain reaction (PCR): Scientists use PCR to make millions of copies of genetic material in a sample. With the help of PCR tests, researchers can detect the coronavirus even when it is scarce.
    • Viral load: The amount of virus in a person’s body. In people infected with the coronavirus, viral loads can peak before symptoms, if any.

The University of Queensland’s vaccine was one of several vaccines under development that contain a coronavirus protein that triggers an immune system response. Protein-based vaccines have a longer track record than some of the newer approaches used by competing coronavirus vaccines, such as those based on viral genes or called adenoviruses.

Prominent protein-based vaccines include one from Novavax of Maryland, which is in Phase 3 trials, and another from Clover Biopharmaceuticals of China, which is in Phase 1.

In the case of the Australian vaccine, it was found to produce a strong immune response and, according to the scientists in the phase 1 study, did not cause any serious side effects. However, proceeding with the vaccine study would have required “significant changes” in longstanding HIV testing procedures, they said.

“This would delay development for another 12 months, and while this is a difficult decision, the urgent need for a vaccine must be everyone’s priority,” Paul Young, a virologist at the university who directed the vaccine effort, said in the Explanation. He did not immediately respond to a request for comment on Friday afternoon.

Australian Health Secretary Greg Hunt told reporters the country still has access to 140 million units of coronavirus vaccines – more than enough to feed its population of approximately 25 million people.

“This is the scientific process that works,” said Hunt. “It’s the planning process that works. It’s an honest explanation for some of the challenges we’ve faced. “

Carl Zimmer contributed to the reporting.

Categories
Business

Pfizer’s Covid Vaccine and Allergic reactions: How Involved Ought to You Be?

Pfizer's Covid Vaccine and Allergies: How Concerned Should You Be?

Dr. Fauci acknowledged that the problem could affect many people.

“That’s one of the reasons it’s important to cover the waterfront with different vaccine platforms,” ​​he said, adding, “When we actually find out that there is a consistent problem with a certain subset of people like people with allergic reactions, You will always have other vaccine platforms to use and hopefully you won’t see that with those other platforms. “

Dr. Paul Offit, a vaccines expert at Philadelphia Children’s Hospital, said the initial, sweeping recommendation in the UK to mention severe allergic reactions was an overreaction that could unnecessarily discourage many people from a much-needed vaccine in the midst of a raging pandemic.

Millions of people in the United States are allergic to foods such as eggs or peanuts, as well as drugs or bee stings, and have had reactions so severe that doctors advised them to wear adrenaline injectors. But that doesn’t necessarily mean the vaccine is risky for them, he said. According to the National Institute of Allergy and Infectious Diseases, about five percent of children and four percent of adults in the United States have food allergies.

Less than 1 in a million recipients of other vaccines each year in the U.S. has an anaphylactic reaction, said Dr. Offit.

These reactions are treatable and much easier to control than a severe case of Covid-19, he said.

Many people with allergies to food, bee stings, or medication have received multiple vaccines without any problems.

The road to a coronavirus vaccine ›

Answers to your vaccine questions

As the coronavirus vaccine nears U.S. approval, here are some questions you may be wondering about:

    • If I live in the US, when can I get the vaccine? While the exact order of vaccine recipients may vary from state to state, most doctors and residents of long-term care facilities will come first. If you want to understand how this decision is made, this article will help.
    • When can I get back to normal life after the vaccination? Life will only get back to normal once society as a whole receives adequate protection against the coronavirus. Once countries have approved a vaccine, they can only vaccinate a few percent of their citizens in the first few months. The unvaccinated majority remain susceptible to infection. A growing number of coronavirus vaccines show robust protection against disease. However, it is also possible that people spread the virus without knowing they are infected because they have mild symptoms or no symptoms at all. Scientists don’t yet know whether the vaccines will also block the transmission of the coronavirus. Even vaccinated people have to wear masks for the time being, avoid the crowds indoors and so on. Once enough people are vaccinated, it becomes very difficult for the coronavirus to find people at risk to become infected. Depending on how quickly we as a society achieve this goal, life could approach a normal state in autumn 2021.
    • Do I still have to wear a mask after the vaccination? Yeah, but not forever. The two vaccines that may be approved this month clearly protect people from contracting Covid-19. However, the clinical trials that produced these results were not designed to determine whether vaccinated people could still spread the coronavirus without developing symptoms. That remains a possibility. We know that people who are naturally infected with the coronavirus can spread it without experiencing a cough or other symptoms. Researchers will study this question intensively when the vaccines are introduced. In the meantime, self-vaccinated people need to think of themselves as potential spreaders.
    • Will it hurt What are the side effects? The vaccine against Pfizer and BioNTech, like other typical vaccines, is delivered as a shot in the arm. The injection is no different from the ones you received before. Tens of thousands of people have already received the vaccines, and none of them have reported serious health problems. However, some of them have experienced short-lived symptoms, including pain and flu-like symptoms that usually last a day. It is possible that people will have to plan to take a day off or go to school after the second shot. While these experiences are not pleasant, they are a good sign: they are the result of your own immune system’s encounter with the vaccine and a strong response that ensures lasting immunity.
    • Will mRNA vaccines change my genes? No. Moderna and Pfizer vaccines use a genetic molecule to boost the immune system. This molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse with a cell, allowing the molecule to slide inside. The cell uses the mRNA to make proteins from the coronavirus that can stimulate the immune system. At any given moment, each of our cells can contain hundreds of thousands of mRNA molecules that they produce to make their own proteins. As soon as these proteins are made, our cells use special enzymes to break down the mRNA. The mRNA molecules that our cells make can only survive a few minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a little longer, so the cells can make extra viral proteins and trigger a stronger immune response. However, the mRNA can hold for a few days at most before it is destroyed.

As a member of the FDA advisory board that met on Thursday, Dr. Offit for approval of the Pfizer vaccine. However, during the panel’s discussion of allergic reactions, he said, “This problem will not die until we have better data.”

He said it should investigate whether any ingredient in the vaccine can cause allergic reactions and whether people with other allergies might be particularly sensitive to it.