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Pfizer to provide as much as 40 million Covid vaccine doses to Covax international program

A nurse prepares the Pfizer BioNTech Covid-19 vaccine on January 10, 2021 at a vaccination center in Sarcelles near Paris.

ALAIN JOCARD | AFP | Getty Images

Pfizer will deliver up to 40 million doses of its coronavirus vaccine to a global alliance that aims to provide coronavirus vaccines to poor nations, the head of the World Health Organization said on Friday.

The agreement will enable Covax – together with the WHO – to deliver vaccine doses to the participating countries from February, said WHO Director General Tedros Adhanom Ghebreyesus during a press conference. Tedros added that until an emergency is approved, the program expects 150 million doses of AstraZeneca’s vaccine to be available for distribution in the first quarter of this year.

The Covax program aims to provide 2 billion doses of Covid-19 vaccines to participating countries, which include low- to middle-income countries, by the end of this year. The Pfizer BioNTech vaccine requires two vaccinations spaced weeks apart, suggesting the deal would only cover 20 million people.

Tedros said the deal would allow other countries with supplies of Pfizer’s vaccine to donate them to the program. The WHO chief criticized wealthy nations for signing supply agreements with drug manufacturers for their starting doses of Covid-19 vaccines to stockpile supplies from poorer nations.

“This is not only important for COVAX, it is also an important step forward for equitable access to vaccines and an essential part of the global effort to fight this pandemic. We will only be safe everywhere if we are safe everywhere,” so Dr. Seth Berkley, CEO of Gavi, the Vaccine Alliance, said in a statement.

Albert Bourla, CEO of Pfizer, said during the press conference that the company will make the vaccine doses available to Covax and poorer countries for a fee. Pfizer was the first company to receive a global list of emergency uses for its vaccine from the WHO, allowing other countries to expedite their regulatory approval processes to begin administering the vaccine.

Bourla said the company will help ship the cans, which require ultra-cold storage and special handling, to low-income countries. UNICEF, which is helping with the dispensing of the cans, previously warned that some of the world’s poorest countries could face the challenge of storing and managing the shots upon arrival.

The program’s contract with Pfizer increases supply agreements to a total of just over 2 billion doses, but negotiations for an additional supply continue. The goal, according to Covax, is to immunize healthcare and other frontline workers as well as some high-risk individuals from the first quarter of this year.

The agreement follows the United States’ decision to remain a member of WHO under President Joe Biden. The new administration will also join the Covax program, a move the Trump administration opposed last year.

“I couldn’t escape the temptation to say that I’m very happy that this press conference is taking place on the day the United States rejoins the WHO organization. I think it’s a symbolic, great day for us,” Pfizer boss Bourla said at the meeting.

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U.S. Vaccine Provide: What to Know

The demand for vaccines is growing rapidly as the US grapples with a record death rate from Covid-19 and the threat of new, more contagious variants. After a slow start in December, many states and cities have rapidly accelerated vaccine delivery, expanded access to larger populations, and established mass testing sites.

But now there’s a new wrinkle: some mayors and governors say they have run out of vaccines available and have had to cancel appointments.

The Biden government has promised to revise the country’s volatile vaccination efforts, but there is only so much it can do to increase the supply available.

Here’s what you need to know.

There are simply not enough doses of approved vaccines to meet the huge demand. And that probably won’t change in the next few months.

The two approved vaccine companies, Moderna and Pfizer, each have promised to make 100 million doses of vaccine available to the United States by the end of March, or enough to give 100 million people the two needed vaccinations.

But that doesn’t mean that those 200 million cans are lying in a factory warehouse somewhere waiting to be shipped. Both companies produce the cans at full capacity and jointly dispense between 12 and 18 million cans per week.

As of Wednesday, nearly 36 million doses of the Pfizer and Moderna vaccines had been distributed to state and local governments. However, only about 16.5 million shots were given to patients.

However, if the local health authorities are better able to handle the distribution of vaccines, they will ultimately catch up with the limited supply. Some local officials, including those in New York City, said they had already reached this point and canceled appointments because they said they didn’t have enough.

Vaccine experts and the companies themselves have stated that applying the Defense Production Act will not add much to supply, at least in the short term, although any little bit could help. This is because production facilities are already full or almost full and there is a global race to develop vaccines that use a limited amount of resources.

Despite criticism of the Trump administration for not using the Defense Production Act more aggressively to stimulate production of test supplies and protective equipment, it used the act many times to give vaccine manufacturers priority access to suppliers of raw materials and equipment.

In a plan released Thursday, the Biden government announced that it would continue to use the law to increase supplies needed to make vaccines, as well as other materials needed to immunize tens of millions of people. Although the plan was few in detail, one example cited is to increase production of a special syringe that can squeeze six doses out of Pfizer vials that were originally supposed to contain five.

There are no vaccine reserves to speak of. For the most part, vaccines are shipped every week when they are made. (The exception is a small emergency supply that the Biden government has announced will continue.)

Last week, Alex M. Azar II, the outgoing Secretary for Health and Human Services, caused confusion when he announced that the federal government would release a reserve of vaccine doses. Many states have been told that an influx of vaccines is on the way that will allow more people to be vaccinated.

In his press conference, Mr Azar urged states to open their vaccination guidelines, saying they moved too slowly to use the doses they had already received. As a result, several governors, including Andrew M. Cuomo of New York, changed admissions rules to allow people 65 and older to have the vaccine.

However, last Friday, senior administration officials made it clear that all of those reserve doses were already earmarked as booster shots for people who had received the vaccine, and that Mr Azar was just setting out the logical extension of a distribution policy established by federal officials in December when supplies began. The release of the reserve doses would go to people who needed their second dose, not new groups of people who received their first shot.

In the future, Azar said, the government will switch to a new model: instead of sticking to a reserve of booster shots, every weekly shipment from the manufacturers would include doses for new people as well as second doses for those due for their booster shots. President Biden repeated this policy when he announced his vaccination schedule last week.

The Biden Administration

Updated

Jan. 21, 2021, 8:45 p.m. ET

Federal officials previously said they worked with states to find out who received a vaccine and when they were due for their booster shots, three weeks later for the Pfizer vaccine, and four weeks later for the Moderna vaccine.

They said that each weekly delivery gives priority to people who need their second dose that week, and what is left is used to vaccinate new people.

However, the plan relies on federal and state governments working together to specify exactly who has received a vaccine and what is needed from week to week. Many state governments have complained that they do not have the resources to carry out the vaccine distribution plan and the next few weeks will show how well the system works.

Biden’s new administration has vowed to revise the distribution to the states to give local officials more transparency on how much vaccine to expect in hopes of allowing states to better plan.

No, that probably won’t happen.

Last week, Michigan Governor Gretchen Whitmer asked the federal government for permission to buy 100,000 doses of vaccine directly from Pfizer. And on Monday, Mr. Cuomo wrote a letter to Pfizer asking the state to buy vaccines direct.

Pfizer and Moderna supplies have been fully drawn for at least the first quarter of this year, meaning a replacement vaccine is unlikely to be sold to individual states.

Additionally, the emergency approvals for the Pfizer and Moderna vaccines provide for the federal government to oversee distribution.

In a statement, a Pfizer spokeswoman said the company is “open to working with the US Department of Health on a distribution model that will allow as many Americans as possible to get access to our vaccine as soon as possible.” However, she noted that “before we can even think about direct sales to state governments, HHS would have to approve the proposal.”

A state official said Tuesday that the governor felt it was important to exhaust all of his options, no matter how unlikely they might be, and pointed to his efforts in March to buy fans direct from manufacturers – which sparked a bidding war between states he later criticized the federal government for refueling.

However, advisors to the Biden government have indicated that they are not in favor of such a move. On Monday, Dr. Celine Gounder, a pandemic advisor to Mr Biden during his change of presidency, said that if states could do separate deals, it would cause more problems than it would solve.

In an interview on CNBC, Dr. Gounder’s earlier criticism from Mr. Cuomo for bidding on ventilators. “I think this kind of approach to vaccine allocation will frankly lead to the same situation that he himself criticized last spring,” she said.

Yes, most likely.

At least three other vaccines are in late-stage clinical trials, and the success of any of those vaccines could mean millions more doses for US citizens by spring.

Johnson & Johnson is expected to announce the results of its vaccine study every day. If this is successful, the first doses could be available in the US by February. Although early production of the vaccine has lagged, the company has signed a contract to deliver 100 million doses of its single-dose vaccine by the end of June.

Results of studies with two-dose vaccines from AstraZeneca and Novavax could also be published by March and April. AstraZeneca has an agreement with the US government to supply 300 million doses and Novavax to supply 110 million doses.

Additionally, both Pfizer and Moderna state that their factories are adding and expanding capacity every week. They have signed contracts to deliver an additional 100 million doses of their vaccines each during the second quarter of this year.

It’s still not clear, though conservative, that there could be enough vaccines by the summer.

With no other vaccines approved, the United States has signed contracts with Pfizer and Moderna for a total of 400 million doses to be dispensed by the summer, or enough for 200 million people.

That’s pretty close to the American population of 260 million adults (the vaccines aren’t yet approved for children, although studies are ongoing).

But if other vaccines prove safe and effective – which experts believe is likely – millions of people could be vaccinated faster, possibly by late spring.

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Biden Inherits a Vaccine Provide Unlikely to Develop Earlier than April

As the Biden administration takes power with a pledge to tame the most dire public health crisis in a century, one pillar of its strategy is to significantly increase the supply of Covid-19 vaccines.

But federal health officials and corporate executives agree that it will be impossible to increase the immediate supply of vaccines before April because of lack of manufacturing capacity. The administration should first focus, experts say, on fixing the hodgepodge of state and local vaccination centers that has proved incapable of managing even the current flow of vaccines.

President Biden’s goal of one million shots a day for the next 100 days, they say, is too low and will arguably leave tens of millions of doses unused. Data collected by the Centers for Disease Control and Prevention suggests that the nation has already reached that milestone pace. About 1.1 million people received shots last Friday, after an average of 911,000 people a day received them on the previous two days.

That was true even though C.D.C. data indicates that states and localities are administering as few as 46 percent of the doses that the federal government is shipping to them. An efficient vaccination regimen could deliver millions more shots.

“I love that he set a goal, but a million doses a day?” said Dr. Paul A. Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of a federal vaccine advisory board.

“I think we can do better,” he said. “We are going to have to if we really want to get on top of this virus by, say, summer.”

The pace of vaccination is critical not just to curbing disease and death but also to heading off the impact of more infectious forms of the virus. The C.D.C. has warned that one variant, which is thought to be 50 percent more contagious, might become the dominant source of infection in the United States by March. Although public health experts are optimistic that the existing vaccines will be effective against that variant, known as B.1.1.7, it may drive up the infection rate if enough people remain unvaccinated.

The current vaccination effort, which has little central direction, has sown confusion and frustration. Some localities are complaining they are running out of doses while others have unused vials sitting on shelves.

Mr. Biden is asking Congress for $20 billion to vastly expand vaccination centers to include stadiums, pharmacies, doctors’ offices and mobile clinics. He also wants to hire 100,000 health care workers and to use federal disaster relief funds to reimburse states and local governments for vaccination costs.

Dr. Mark B. McClellan, the director of Duke University’s health policy center, said those moves should help clear the bottlenecks and “push the number beyond a million doses a day and probably significantly beyond.”

The nation’s vaccine supply in the first three months of the year is expected to substantially exceed what is needed to meet the administration’s goal. According to a senior administration official, Pfizer-BioNTech and Moderna have been ramping up and are now on track to deliver up to 18 million doses a week. Together, they have pledged to deliver 200 million doses by the end of March. A third vaccine maker, Johnson & Johnson, might also come through with more doses. If all of that supply were used, the nation could average well over two million shots a day.

Asked Thursday afternoon by a reporter if one million shots a day was enough, Mr. Biden said: “When I announced it, you all said it’s not possible. Come on, give me a break, man. It’s a good start.”

Covid-19 Vaccines ›

Answers to Your Vaccine Questions

If I live in the U.S., when can I get the vaccine?

While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.

When can I return to normal life after being vaccinated?

Life will return to normal only when society as a whole gains enough protection against the coronavirus. Once countries authorize a vaccine, they’ll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But it’s also possible for people to spread the virus without even knowing they’re infected because they experience only mild symptoms or none at all. Scientists don’t yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.

If I’ve been vaccinated, do I still need to wear a mask?

Yes, but not forever. The two vaccines that will potentially get authorized this month clearly protect people from getting sick with Covid-19. But the clinical trials that delivered 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 by the coronavirus can spread it while they’re not experiencing any cough or other symptoms. Researchers will be intensely studying this question as the vaccines roll out. In the meantime, even vaccinated people will need to think of themselves as possible spreaders.

Will it hurt? What are the side effects?

The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection won’t be any different from ones you’ve gotten before. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. But some of them have felt short-lived discomfort, including aches and flu-like symptoms that typically last a day. It’s possible that people may need to plan to take a day off work or school after the second shot. While these experiences aren’t pleasant, they are a good sign: they are the result of your own immune system encountering the vaccine and mounting a potent response that will provide long-lasting immunity.

Will mRNA vaccines change my genes?

No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.

The administration is promising to purchase even more vaccine doses as they become available from the vaccine makers, and to use the Defense Production Act to spur production. But federal health officials and corporate executives said those were longer-term goals because the supply for the first three months of the year was essentially fixed.

The Trump administration invoked the Defense Production Act to force suppliers to prioritize orders from Pfizer, Moderna and other vaccine makers whose products are still in development. Health officials said it was unclear how the new administration could use the law beyond that to boost production.

One senior federal health official involved in the government’s vaccine efforts said that Operation Warp Speed, the Trump administration’s crash development program, had looked at all available manufacturing capacity domestically and globally and that there was little space left to negotiate at this point. The official said that if there had been more doses available to the government in the first quarter, they would have been purchased.

Experts generally agree that the federal government should be locking in purchases of as many doses as possible because no one knows yet how long the vaccines will protect against the coronavirus, whether booster shots will be required and what threats mutations of the virus could pose.

From April and thereafter, the supply outlook brightens. Pfizer and Moderna have each committed to supply another 100 million doses by the end of July, and the companies might be able to provide even more. A week ago, Pfizer and BioNTech, its German partner, increased their global production target to 2 billion doses for the year from 1.3 billion doses.

Pfizer has delayed deliveries to European countries while it retools its Belgium factory to expand production. But at the firm’s factory in Kalamazoo, Mich., which supplies doses for Americans, production has quickened since the federal government ordered suppliers to prioritize Pfizer’s needs. The unexpected discovery that efficient syringes could extract a sixth dose from its vials also upped Pfizer’s estimates.

Moderna has also raised its production targets for the year to 600 million doses, up from 500 million.

Johnson & Johnson is expected to announce results from its vaccine trial within days. If that vaccine proves effective, it could drastically speed up the pace of vaccinations because unlike Moderna’s and Pfizer-BioNTech’s vaccines, it requires only one dose. The company could apply for emergency use authorization from the Food and Drug Administration as soon as the end of the month. While its manufacturing has lagged, Johnson & Johnson is trying to catch up to the goals detailed in the federal contract it signed last year.

The firm is now expected to deliver anywhere from several million to 12 million doses by the end of February, and 10 million to 20 million more doses at the end of March or the first week in April, according to several people familiar with the firm’s manufacturing output. The first batch would be produced at its Dutch factory, and later batches at a factory in Baltimore operated by its manufacturing partner, Emergent BioSolutions.

But to deliver the second batch that quickly, federal regulators may have to agree to delay certain manufacturing reviews of the vaccine from the Baltimore plant, according to people familiar with the situation. Those discussions are now underway.

Johnson & Johnson is also in preliminary talks with Merck, a major American pharmaceutical company, about using its production lines, one of several ideas that federal health officials discussed with the Biden transition team. Federal officials are interested in boosting the nation’s vaccine-making power long-term, and Merck’s facilities may be among the few with remaining manufacturing capability.

But Dr. McClellan, who sits on Johnson & Johnson’s board of directors, said it would take months to adapt Merck’s factory to produce Johnson & Johnson’s vaccine. A senior administration official predicted that it could take until the end of the year.

Other vaccine makers may also come through by midyear. Novavax has worked to iron out what were recently dire manufacturing problems that delayed its clinical trials. Moncef Slaoui, the scientific head of the federal vaccine development program in the Trump administration, said in a recent interview that Novavax could apply for emergency use authorization in late April. The government has already ordered 110 million doses of the Novavax vaccine, to be delivered by the end of June, and Novavax has said it believes it can meet that target.

Mr. Biden has surrounded himself with new health officials assigned to getting vaccines from factories to recipients, including Dr. Bechara Choucair, the former Chicago health commissioner who is the White House’s vaccinations coordinator, and Tim Manning, a former top official at the Federal Emergency Management Agency who is now the supply coordinator. Dr. David Kessler, the former F.D.A. commissioner, will help lead the federal government’s vaccine development program at the Department of Health and Human Services, with special attention to manufacturing.

After both the Pfizer-BioNTech and Moderna vaccines proved to be highly effective in clinical trials late last year, the Trump administration considered whether to rethink its strategy of backing six different vaccine makers and instead throw all of its weight behind the proven producers. One senior administration official described “countless hours of debate” over the issue.

In the end, officials decided it was critical to keep aiming for a broad portfolio of vaccines, in part because no one has figured out which vaccines might work best for children or be most effective against emerging variants. They recommended that the Biden administration do the same.

Katie Thomas and Donald G. McNeil Jr. contributed reporting.

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Inconsistent provide is largest problem, says NJ hospital CEO

Michael Maron, CEO of the Holy Name Medical Center, told CNBC on Tuesday that its New Jersey hospital’s Covid vaccination efforts had been hampered by a consistent problem: inconsistent availability.

“The biggest challenge we are currently facing is delivering the vaccine. We just can’t get it and we can’t get it any reliable way. It’s very difficult,” said Maron at the Power Lunch.

“One week we have Pfizer, the next week Moderna,” he added, referring to the manufacturers of the two vaccines, which have received emergency approval from the US Food and Drug Administration. “We never know exactly how much of it is, whether it’s a thousand doses … or two thousand or more.”

The Holy Name Medical Center in Teaneck, near New York City, has so far administered about 5,000 doses of the vaccine, Maron said. However, according to Maron, the hospital can deliver 3,000 doses a day, in part thanks to a partnership with Teaneck to set up a vaccination center at a community center.

According to a post on Teaneck’s official website, 570 residents received the vaccine locally on Monday. Due to the “lack of vaccine available,” wrote community administrator Dean Kazinci, the website will be closed on Tuesday – an example of the supply problems Maron referred to.

“Holy Name Medical Center is waiting for additional trays of the vaccine to arrive mid-week. We will post additional information as it becomes available,” Kazinci wrote.

As of Tuesday afternoon, the Holy Name website will also inform visitors that the hospital is not planning any Covid vaccination appointments “at this time” due to availability restrictions.

The rollout of Covid vaccines in the US has been slower than officials had hoped. According to the latest available data compiled by the Centers for Disease Control and Prevention, approximately 12.3 million doses had been administered as of Friday. 31.2 million cans were distributed.

President-elect Joe Biden, who will take office on Wednesday, has vowed to accelerate the introduction of the vaccine, with a pledge to deliver 100 million doses in 100 days. On Sunday, Biden’s election to head the CDC said Dr. Rochelle Walensky, she believes the US would have sufficient vaccine supplies to meet the target.

“It’s going to be a tough lift, but we’ve got enough to do that,” Walensky said on CBS ‘Face the Nation.

Covid hospital stays

While Covid vaccinations are crucial in limiting the effects of the disease, Maron warned that the U.S. coronavirus outbreak is a current threat. On Tuesday, the death toll in Covid exceeded 400,000, just over a month after 300,000 deaths were recorded. This is based on data compiled by Johns Hopkins University.

Maron said Covid hospital stays at Holy Name Medical Center are not at the level of the pandemic as they were in March and April. The hospital now has better treatments for patients too, he said. Still, he said a worrying aspect was the age of the patients who were hospitalized with the disease.

“It’s not who you would think,” said Marron. “They’re mostly people between the ages of 45 and 65, so these aren’t the frail elderly people everyone was talking about. They’re the ones who work on the ventilators, so we were a little worried.”

He said it was not clear what caused the hospitalizations among younger U.S. residents. “For us here in the industry, it’s a reminder that this is still a very, very serious and deadly virus. We shouldn’t take it lightly.”