Tag: Vaccine

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Health

FDA says it hasn’t authorized Moderna Covid vaccine regardless of Trump tweet

FDA says it hasn't approved Moderna Covid vaccine despite Trump tweet

US President Donald Trump gives a speech at an Operation Warp Speed ​​Vaccine Summit on December 8, 2020 at the White House in Washington, USA.

Tom Brenner | Reuters

The Food and Drug Administration has not yet approved Moderna’s coronavirus vaccine, contrary to a tweet from President Donald Trump on Friday that said the agency had “overwhelmingly approved” it and would distribute it immediately.

The FDA did not comment on Trump’s tweet, instead referring CNBC to a statement from FDA Commissioner Dr. Stephen Hahn said Thursday evening that the agency would “work quickly towards finalizing and issuing emergency clearance” for Moderna’s vaccine.

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

The FDA statement on Thursday “is current,” FDA spokesman Michael Felberbaum told CNBC after Trump’s tweet.

It’s possible that Trump was referring to a vote by the FDA’s Advisory Committee on Vaccines and Related Biological Products Thursday, which voted 20-0, with one member abstaining to approve Moderna’s emergency vaccine advocate. The advisory board plays a key role in approving influenza and other vaccines in the US and verifying that the vaccinations are safe for public use. While the FDA does not need to follow the advisory board’s recommendation, it often does.

The FDA is expected to approve Moderna’s vaccine as early as Friday. The US plans to ship close to 6 million cans next week pending agency approval. This was announced by General Gustave Perna, who oversees the logistics for the Operation Warp Speed ​​vaccination project, to reporters on Monday.

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Health

Employers Can Require Employees to Get Covid-19 Vaccine, U.S. Says

Employers Can Require Workers to Get Covid-19 Vaccine, U.S. Says

Even so, employers may need to be careful about how they handle the process.

Pre-screening vaccination questions could violate an ADA provision for disabled-related inquiries. According to the guidelines, employers who administer vaccines must demonstrate that pre-screening questions are “job-related and consistent with business need”.

Covid19 vaccinations>

Answers to your vaccine questions

With a coronavirus vaccine spreading out of the US, here are answers to 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. Here’s why. The coronavirus vaccines are injected deep into the muscles and stimulate the immune system to produce antibodies. This seems to be sufficient protection to protect the vaccinated person from disease. What is not clear, however, is whether it is possible for the virus to bloom in the nose – and sneeze or exhale to infect others – even if antibodies have been mobilized elsewhere in the body to prevent that vaccinated person gets sick. The vaccine clinical trials were designed to determine if people who were vaccinated are protected from disease – not to find out if they can still spread the coronavirus. Based on studies of flu vaccines and even patients infected with Covid-19, researchers have reason to hope that people who are vaccinated will not spread the virus, but more research is needed. In the meantime, everyone – including those who have been vaccinated – must imagine themselves as possible silent shakers and continue to wear a mask. Read more here.
    • 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 in your arm feels no different than any other vaccine, but the rate of short-lived side effects seems to be higher than with the flu shot. Tens of thousands of people have already received the vaccines, and none of them have reported serious health problems. The side effects, which can be similar to symptoms of Covid-19, last about a day and are more likely to occur after the second dose. Early reports from vaccine trials suggest that some people may need to take a day off because they feel lousy after receiving the second dose. In the Pfizer study, around half developed fatigue. Other side effects occurred in at least 25 to 33 percent of patients, sometimes more, including headache, chills, and muscle pain. While these experiences are not pleasant, they are a good sign that your own immune system is having a strong response to the vaccine that provides 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.

The instruction takes place in the midst of the skepticism about the vaccinations among large parts of the public. A recent survey of about 2,000 New York firefighters found that, according to CNN, nearly 55 percent said they would not get a vaccine if offered by their department.

According to a poll by Pew Research, only 42 percent of black Americans say they have been vaccinated. According to a November Gallup panel poll, 58 percent of Americans said they were receiving a total of one Covid-19 vaccine.

Suspicions about vaccinations are also being fueled by political commentators and groups.

On his Fox News Show this week, Tucker Carlson shared the stories of a small number of Americans who have had side effects from Pfizer’s vaccine. And extremism experts have warned that groups that have protested election results and Covid-19 bans in the United States are now turning their attention to the anti-vaccine movement.

The introduction of a vaccine and urgent logistical questions about its spread signals that the end of the pandemic is in sight, but the virus is also deadlier than ever. The US reports more than 3,000 deaths per day for the first time this month.

As the federal and state governments prepare for extensive vaccination efforts, the Trump administration’s message about the pandemic remains mixed up.

Vice President Mike Pence hosted a Christmas party a few days ago at his residence, at which, according to the participants, the guests posed for pictures without a mask. But on Friday morning, Mr Pence received his first vaccine shot on live television. He was joined by his wife, Karen Pence, and surgeon-general Jerome Adams.

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Health

Moderna Covid vaccine FDA accepted for emergency use

Moderna Covid vaccine FDA approved for emergency use

The Food and Drug Administration has approved Moderna’s coronavirus vaccine for emergency use. The vaccine – the second to be approved for use in the US after Pfizer and BioNTech – strengthens the US dose supply. The potentially life-saving shots are badly needed to fight the pandemic that left more than 300,000 Americans dead and hospitals overwhelmed.

With the FDA’s approval for the emergency on Friday, the federal government’s plan to distribute approximately 5.9 million doses of Moderna’s vaccine to 64 states, territories and major cities across the country next week will be approved.

“We’ll probably see gunshots in the arm early next week, I hope Monday or Tuesday,” said Dr. Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases, on the “Today” show on Friday morning.

President Donald Trump said in a tweet: “Congratulations, the Moderna vaccine is now available!”

In addition to Moderna’s vaccine, the U.S. is planning to ship 2 million doses of Pfizer’s vaccine after 2.9 million doses were cleared for shipping this week, General Gustave Perna, who oversees logistics for the Operation Warp Speed ​​vaccination project, said Monday . Both vaccines require two doses three to four weeks apart. Moderna’s Covid vaccine is the first product to be approved by the FDA.

“With the availability of two vaccines to prevent COVID-19, the FDA has taken another crucial step in the fight against this global pandemic, which causes large numbers of hospitalizations and deaths in the US every day,” said FDA Commissioner Dr. Stephen Hahn said in a statement.

US officials hope to vaccinate at least 20 million Americans by the end of the year – mostly healthcare frontline workers and nursing home residents. The initial doses will be limited as production increases. Officials predict it will be months before everyone in the US who wants to be vaccinated is vaccinated. The Centers for Disease Control and Prevention has given states an overview recommending that health workers and nursing homes be prioritized. However, states may distribute the vaccine at their own discretion.

States are already reporting confusion about vaccination plans. In the past few days, state officials said they learned that their second shipment of Pfizer’s vaccine would be smaller than expected or delayed. In Florida, for example, Republican Governor Ron DeSantis said the federal government had told him the state would receive 205,000 Pfizer vaccine doses next week and 247,000 the following week. Those shipments are now on hold, DeSantis said at a press conference Tuesday, and it is unclear when they will arrive.

Moderna’s vaccine, like Pfizer’s, uses messenger RNA or mRNA technology. It’s a new approach to vaccines that uses genetic material to trigger an immune response. Late-stage clinical trial data released last month shows that Moderna Covid’s vaccine is more than 94% effective at preventing, safe and appearing to fight off serious diseases. For maximum effectiveness, the vaccine requires two doses four weeks apart.

The FDA has announced that it will approve a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.

The FDA has approved Moderna’s vaccine for people aged 18 and over. Such authorization by the agency is not the same as a full authorization, which requires more data and can usually take several months longer. Moderna only submitted security data for two months. The agency typically takes six months for full approval and can revoke an EEA for a drug at any time if it doesn’t work as intended or if it proves unsafe. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March but revoked it in June after additional data showed it provided “no evidence of benefit” in coronavirus patients.

The FDA announcement comes after a key agency advisory body voted 20-0 with one abstention on Thursday to recommend the emergency vaccine. The Advisory Committee on Vaccines and Related Biological Products plays a key role in approving influenza and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not need to follow the advisory board’s recommendation, it often does.

Prior to the vote, some committee members stressed their approval of Moderna’s vaccine was not in favor of full FDA approval, and reiterated that the agency needed to review more data on safety and efficacy.

During the meeting, outside medical experts asked the agency about allergic reactions reported in two Alaskan health workers who were taking Pfizer’s vaccine. Doran Fink, deputy director of the FDA’s vaccines and related product applications division, said the agency is looking into the problem.

“As we continue to examine and evaluate the data, we will consider whether additional recommendations need to be made,” he said. “Right now we don’t have enough data to make a definitive recommendation one way or another.”

Fatigue, headaches, and muscle aches are the most common side effects of Moderna’s vaccine, along with some rare symptoms such as persistent nausea or vomiting and facial swelling, which the FDA says are likely caused by the gunfire. Some side effects were tough to shake, although most were resolved within a week, the FDA said.

The FDA said while this isn’t necessarily a side effect, it does recommend monitoring people who receive Pfizer’s or Moderna’s vaccine shots for possible cases of Bell’s palsy, a condition that causes sudden freezing or weakness of facial muscles. The agency also found a higher prevalence of lymphadenopathy, a disease that can cause swollen or enlarged lymph nodes, in the vaccine group compared to the placebo groups in Pfizer and Moderna studies.

According to Moderna, the vaccine will stay stable for up to 30 days at 36 to 46 degrees Fahrenheit, the temperature of a normal household or medical refrigerator. It can be stored at minus 4 degrees Fahrenheit for up to six months. In comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit.

The federal government announced last week it would buy another 100 million doses of Moderna’s vaccine. The US reached an agreement with Moderna in August to purchase 100 million cans for about $ 1.5 billion. Moderna said it charged some customers $ 32 to $ 37 per dose for its vaccine at lower “pandemic prices” this month. The company said it was under discussion for larger volume agreements that will have a lower price.

– CNBC’s Noah Higgins-Dunn and Will Feuer contributed to this report.

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World News

Covax, a world well being group, broadcasts vaccine offers to assist much less rich international locations.

Covax, an international health group, announces vaccine deals to help less wealthy countries.

Leaders of an international body promoting global access to coronavirus vaccines, known as Covax, announced on Friday that additional efforts were being made with manufacturers that would provide access to nearly two billion doses of vaccine candidates, more than that Half were intended to be shipped to low and middle income countries.

The aim of the effort is to ensure vaccination of a fifth of the population of the 190 participating countries and economies before the end of next year.

The new contracts cover vaccines that are still under study for efficacy and safety, one from AstraZeneca and the University of Oxford and one from Johnson & Johnson. As of the ongoing discussions, no agreements have been made to source the FDA-cleared BioNTech Pfizer vaccine, which is already being used in countries such as the US and the UK.

The international effort was led by the Gavi public-private health partnership, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations, and the World Health Organization.

Friday’s announcement contained the news that a mechanism had been developed for countries with overdoses to share it.

Many high-income nations have agreements with multiple manufacturers that could result in significantly more doses than are required to vaccinate their entire population. Officials from Canada and France announced that they intend to contribute their additional doses via Covax, although they have not given a schedule or say whether they would vaccinate their entire population first.

France will “start exchanging vaccines as early as possible,” said Stephanie Seydoux, the country’s ambassador for global health, at a press conference.

  • In other developments around the world:

  • in the South AfricaScientists and health officials on Friday announced the discovery of a new line of coronavirus that is rapidly dominating virus samples tested in the country. The variant, named 501.V2, has also been associated with faster spread and higher viral load in swabs in a preliminary analysis. Scientists are studying it closely because the variant contains several changes in the part of the virus that allows it to attach to human cells, which is an important target for antibody therapies and vaccines.

  • in the Europe, In the run-up to Christmas there is a patchwork of guidelines across the continent as 500,000 people die. . Germany has put a strict lockdown on Christmas week, and the Netherlands and Italy will take stricter measures during the holidays. France and Spain have some restrictions but have opposed new national bans. In the UK, Prime Minister Boris Johnson has been criticized for lifting restrictions on Christmas gatherings despite the rise in new infections. The Regional Director of the World Health Organization, Dr. Hans Henri P. Kluge said in a statement on Friday that it is not now time for Europeans to ease restrictions.

  • As coronavirus cases and hospital stays in Sweden continue to rise, the government issued several new recommendations on Friday, including the use of face masks. “We have to do more now because the medical system is tense,” said Prime Minister Stefan Lofven. The new recommendations include a limit of four people per table in restaurants, cafes and bars, as well as a ban on selling alcohol after 8 p.m. Stores, shopping centers and gyms are asked to limit the number of customers further.

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Business

F.D.A. Clears Moderna’s Covid Vaccine

F.D.A. Clears Moderna's Covid Vaccine

The Food and Drug Administration on Friday authorized the coronavirus vaccine made by Moderna for emergency use, allowing the shipment of millions more doses across the nation and intensifying the debate over who will be next in line to get inoculated.

The move will make Moderna’s vaccine the second to reach the American public, after the one by Pfizer and BioNTech, which was authorized just one week ago.

The F.D.A.’s decision sets the stage for a weekend spectacle of trucks rolling out as expert committees begin a new round of discussions weighing whether the next wave of vaccinations should go to essential workers, or to people 65 and older, and people with conditions that increase their risk of becoming severely ill from Covid-19.

Jockeying for the next shots in January and February has already begun, even though there is still not enough of the two vaccines for all the health care workers and nursing home staff members and residents given first priority. Uber drivers, restaurant employees, morticians and barbers are among those lobbying states to include them in the next round along with those in the more traditional categories of the nation’s 80 million essential workers, like teachers and bus drivers.

The rapid progress from lab to human trials to public inoculation has been almost revolutionary, spurred by the nation’s urgent need to blunt the pandemic that has broken record after record in U.S. deaths, hospitalizations and economic losses. In the last week alone, there has been an average of 213,165 cases per day, an increase of 18 percent from the average two weeks earlier. And the daily death toll in recent days has surpassed 3,200.

Dr. Anthony S. Fauci, the nation’s top infectious disease expert, called the advent of two vaccines “an historic moment.”

“This to me is a triumph of multiyear investment in biomedical research that culminated in something that was not only done in record time, in the sense of never before has anybody even imagined you would get vaccines to people in less than a year from the time that the sequence was made known,” Dr. Fauci said.

“This is an example of government working. It worked really well,” he added.

Moderna, a company based in Cambridge, Mass., worked with Dr. Fauci’s agency at the National Institutes of Health to create a vaccine that, along with Pfizer-BioNTech’s, shepherds in a new technology based on genetic material called messenger RNA or mRNA. In clinical trials in tens of thousands of volunteers, the vaccines proved 94 to 95 percent effective. Each requires two shots.

Both products are reaching an anxious public before vaccines made with traditional approaches, and have become even more critical as other companies’ efforts have faltered in recent months.

The emergency authorization kicks off a swift and complex drive to distribute some 5.9 million doses of the Moderna vaccine around the country, with shipping to begin on Sunday and deliveries starting on Monday. The first Moderna vaccinations could then be given hours later.

Because Moderna’s vaccine, unlike Pfizer-BioNTech’s, does not need extreme-cold storage and is delivered in smaller batches, states are hoping to provide it to less populated areas, reaching rural hospitals, local health departments and community health centers that were not at the top of the distribution list.

Three places that did not receive the Pfizer-BioNTech vaccine — the Marshall Islands, Micronesia and Palau — will receive the Moderna vaccine for that reason, according to a federal health official familiar with the government’s distribution plans.

And in contrast to Pfizer’s rollout last week, the Moderna vaccine deliveries will be managed by the federal government under the funding of Operation Warp Speed, the administration’s program to develop and distribute vaccines as fast as possible.

Supplies of a second vaccine cannot come soon enough. Several governors and state health officials said on Friday that they were dismayed to learn they would be getting less of the Pfizer-BioNTech vaccine next week than the federal government had promised.

Dr. Mark Levine, commissioner of the Vermont Department of Health, said in a Friday briefing: “All my colleagues in the region are reporting a 25 to 35 percent decrease in their allocation for next week. As we were walking in, I learned as many as 975 doses out of an expected 5,850 doses would not be coming in when we expected. That doesn’t mean we won’t be getting all of those doses. It just means they won’t be coming in when we expected.”

He added, “What everyone around the country is upset about, in addition to just the number, is there’s been no communication, so there’s no understanding of what this really means.”

Covid-19 Vaccines ›

Answers to Your Vaccine Questions

With distribution of a coronavirus vaccine beginning in the U.S., here are answers to some questions you may be wondering about:

    • 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. Here’s why. The coronavirus vaccines are injected deep into the muscles and stimulate the immune system to produce antibodies. This appears to be enough protection to keep the vaccinated person from getting ill. But what’s not clear is whether it’s possible for the virus to bloom in the nose — and be sneezed or breathed out to infect others — even as antibodies elsewhere in the body have mobilized to prevent the vaccinated person from getting sick. The vaccine clinical trials were designed to determine whether vaccinated people are protected from illness — not to find out whether they could still spread the coronavirus. Based on studies of flu vaccine and even patients infected with Covid-19, researchers have reason to be hopeful that vaccinated people won’t spread the virus, but more research is needed. In the meantime, everyone — even vaccinated people — will need to think of themselves as possible silent spreaders and keep wearing a mask. Read more here.
    • 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 into your arm won’t feel different than any other vaccine, but the rate of short-lived side effects does appear higher than a flu shot. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. The side effects, which can resemble the symptoms of Covid-19, last about a day and appear more likely after the second dose. Early reports from vaccine trials suggest some people might need to take a day off from work because they feel lousy after receiving the second dose. In the Pfizer study, about half developed fatigue. Other side effects occurred in at least 25 to 33 percent of patients, sometimes more, including headaches, chills and muscle pain. While these experiences aren’t pleasant, they are a good sign that your own immune system is mounting a potent response to the vaccine 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.

Gov. Charlie Baker of Massachusetts said on Friday, “We’re certainly frustrated,” referring to the reduced number of Pfizer-BioNTech doses his state would receive next week — 42,900 instead of 59,000. Demand for the vaccine is high.

“So far, hospitals are reporting overwhelming acceptance from doctors, nurses and other workers who are eligible to be vaccinated,” he said.

Pointing out how hard hit Wisconsin has been, Gov. Tony Evers complained that the state was receiving significantly less of the Pfizer-BioNTech vaccine than it had been promised — 35,100 doses instead of 49,725. In a statement on Friday, he said, “We call on the federal government to send us more vaccine without delay.”

Because Moderna’s vaccine requires two doses, federal officials are holding another 5.9 million doses for shipment four weeks after the first wave, as the doses are spaced a month apart. The federal government also plans to reserve more than 500,000 doses in case of problems with the initial shipment.

Officials expect to inform states next week the number of doses they plan to send in the second wave of shipments.

The emergency authorization Friday was the product of an F.D.A. review process that compressed an extraordinary amount of work into weeks, and occurred at the same time regulators were poring over materials for the Pfizer-BioNTech vaccine.

The overlap led to a grueling schedule for the reviewers. Large teams organized into specialties — epidemiology, statistics and manufacturing among them — and reviewed Moderna’s application day and night once the company submitted its data in late November.

Among the review’s components were teams that examined company production facilities and clinical trial sites to affirm that records corresponded to the materials Moderna had submitted to federal regulators.

The F.D.A.’s advisory panel also had to consider new information — reports of severe allergic reactions, two in Britain and two in the United States, in people who received the Pfizer-BioNTech vaccine after it was authorized. Although that vaccine is not identical to Moderna’s, they are similar. The agency and the Centers for Disease Control and Prevention are investigating the cases, but say the vaccines can be safely administered to most people who have allergies, with careful monitoring.

The F.D.A.’s authorization also represented a capstone to a sprawling government-led effort that began in January, when scientists at the National Institutes of Health and Moderna designed the vaccine within two days of China’s releasing the genetic sequence of the new virus.

The company had never brought a product to market, giving it an underdog status as its vaccine was tested on the same timetable as Pfizer-BioNTech’s. Moderna enjoyed an unusually intimate relationship with Operation Warp Speed, which has monitored its supply on an almost hourly basis this year. The company benefited from nearly $2.5 billion in federal funds used to buy raw materials, expand its factory and enlarge its work force by 50 percent.

Public health experts and federal officials still estimate that it will be at least six months, if not longer, before most Americans can be vaccinated. And that depends on whether other vaccines in trials are successful and receive emergency approval.

The federal government is counting on building supplies from vaccines under development by several others — one from Johnson & Johnson, one from Sanofi of France and GlaxoSmithKline of Britain, and another from the British-Swedish drug maker AstraZeneca and the University of Oxford.

On Saturday and Sunday, experts advising the C.D.C. will take up Moderna’s vaccine and ultimately vote on the next tiers of people who should get the vaccines. The committee vote on Sunday will most likely set off a frenzy of difficult decision-making at the state level that could be further complicated by bumps in the vaccine production process.

Behind the scenes is McKesson, based in Irving, Texas, one of the country’s largest distributors of drugs and medical supplies. The company has a long history of distributing vaccines and is the largest distributor of the seasonal flu vaccine in the United States.

McKesson also played a central role in the opioid epidemic and is part of a group of companies closing in on a potential $26 billion settlement with state and local governments.

The company will be the main distributor of the Moderna vaccine. Pfizer-BioNTech itself is distributing its vaccine, which needs to be kept at minus 94 degrees Fahrenheit.

McKesson is also producing kits that include the supplies needed to administer both vaccines.

McKesson is assembling the kits at two of its distribution centers, one near Louisville, Ky., a major hub for UPS, and another near Memphis, where FedEx is based.

While McKesson has its own fleet of trucks, it is largely relying on FedEx and UPS to ship the kits and vaccines.

Each kit includes needles, syringes, alcohol prep pads, face shields and surgical masks, administration sheets for health care providers, and vaccination record and reminder cards for patients.

McKesson has outfitted at least two of its distribution centers with specially designed, 10,000-square-foot freezers designed to store millions of doses of the Moderna vaccine. Altogether, McKesson has added more than 3.3 million square feet of space to manage the project.

When the time comes to send the Moderna doses out, McKesson will pack the doses into coolers it sourced from Cold Chain Technologies, a company in Franklin, Mass. Those coolers will be packed with coolant packs, and then sent to administration sites via FedEx and UPS. The coolers also contain monitoring devices that indicate whether the vaccines ever got too warm.

McKesson has hired more than 1,000 people to help with the effort, and expects to hire up more than 2,500 more in the months ahead.

David Gelles, Katherine J. Wu, Sharon LaFraniere and Reed Epstein contributed reporting.

Categories
Health

Putin calls on public to take the coronavirus vaccine

Putin calls on public to take the coronavirus vaccine

Russian President Vladimir Putin spoke on screen during his annual press conference on December 17, 2020 in Moscow.

Mikhail Svetlov | Getty Images News | Getty Images

Russia’s President Vladimir Putin urged the public to receive the coronavirus vaccine but said he has not yet received it himself.

At his annual press conference in December on Thursday, Putin encouraged Russians to take the Sputnik V vaccine and said he would receive it as soon as he was able.

“Our health care professionals say the vaccines … are for people of certain ages … people like me are not allowed to take vaccines yet. I’m a law abiding citizen and I always listen to what our health care professionals say, that’s why I haven’t been vaccinated yet, but I will certainly do that as soon as it is allowed. “

“Our vaccine is effective and safe, so I see no reason why we should be afraid of getting a shot,” he said, adding that Russia’s priority is to vaccinate its own citizens and increase its manufacturing capacity this.

Sputnik V has been tested on volunteers aged 18 to 60 years and is therefore only recommended for people between these age groups. Since Putin is 68 years old, he does not qualify.

The Russian direct investment fund, which supports the Russian vaccine, said Thursday that a separate study will be conducted in the age group over 60 to see if it is “safe and efficient” for the elderly.

Vaccinating the elderly, and especially those with underlying health needs, is considered a priority by most experts as they are the most susceptible to dying from Covid-19. In the UK, where the Pfizer BioNTech vaccine is already being made available to the public, the elderly and health care workers are the first to receive it.

Attempts in over 60 years

The Russian news agency Tass reported in October that the first group of volunteers aged 60 and over had been vaccinated with the Russian Sputnik V, which was attended by a total of 110 people.

The first group of volunteers had 28 members, including people with chronic conditions common to the elderly, such as diabetes, high blood pressure and chronic kidney failure. The oldest person in the group was 82, Tass reported.

The chief researcher of the Central Clinical Hospital of Russia, Nikita Lomakin, who leads the studies, said no negative reactions were observed in the first group.

Later in October, the head of the Federal Research Center for Epidemiology and Microbiology in Gamaleya said people over 60 will develop Covid antibodies after being vaccinated, but they may be less effective than those produced by younger people.

“The vaccination has definitely started, a certain number of people aged 60, 70, maybe even 80 years of age have been vaccinated,” said Alexander Gintsburg of Gamaleya, Tass reported. “We don’t expect anything out of the ordinary, there won’t be any additional side effects, they’ll develop antibodies. The only thing is to what extent the antibodies neutralize the virus: younger people develop antibodies that interact very well with the virus, while older people develop antibodies that a lot.” interact less with the virus – dozens or even hundreds of times less. “

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Health

Well being Care Employee Had Critical Allergic Response After Pfizer’s Covid Vaccine

Health Care Worker Had Serious Allergic Reaction After Pfizer's Covid Vaccine

WASHINGTON – Two health care workers at the same Alaska hospital developed reactions just minutes after receiving the coronavirus vaccine from Pfizer this week, including a worker who was supposed to stay in the hospital until Thursday.

Health officials said the cases would not disrupt their plans to launch vaccines and that they would share the information for the sake of transparency.

The first worker, a middle-aged woman with no history of allergies, had an anaphylactic reaction that began 10 minutes after receiving the vaccine at the Bartlett Regional Hospital in Juneau on Tuesday, a hospital official said. She had a rash over her face and trunk, shortness of breath, and an increased heart rate.

Dr. Lindy Jones, the hospital’s emergency room medical director, said the worker was first given a shot of adrenaline, a standard treatment for severe allergic reactions. Her symptoms subsided, but then came back and she was treated with steroids and an adrenaline drop.

When the doctors tried to stop the drip, her symptoms reappeared, so the woman was taken to the intensive care unit, which was observed all night, and then taken off the drip early Wednesday morning, Dr. Jones.

Dr. Jones had said earlier Wednesday that the woman should be discharged that evening, but the hospital said late Wednesday that she would be staying one more night.

The second worker received his shot Wednesday and developed eye swelling, lightheadedness and a sore throat 10 minutes after the injection, the hospital said in a statement. He was taken to the emergency room and treated with adrenaline, Pepcid, and Benadryl, though the hospital said the reaction wasn’t anaphylaxis. The worker was back to normal within an hour and was released.

The hospital, which had given a total of 144 doses on Wednesday night, said both workers didn’t want their experience to negatively impact others who line up for the vaccine.

“We have no plans to change our vaccination schedule, dosage, or treatment regimen,” said Dr. Anne Zink, Alaska’s chief medical officer, in a statement.

Although the Pfizer vaccine was shown to be safe and 95 percent effective in a clinical trial of 44,000 participants, the Alaska cases are likely to heighten concerns about possible side effects. Experts said developments could lead to calls for stricter guidelines to ensure recipients were carefully monitored for side effects.

Dr. Paul A. Offit, a vaccine expert and a member of an outside advisory panel that recommended the Food and Drug Administration approve Pfizer’s emergency vaccine, said the appropriate precautions have already been taken. For example, he said, requiring recipients to remain in place for 15 minutes after receiving the vaccine helped ensure that the woman was treated quickly.

“I don’t think this means we should take a break,” he said. “Not at all.” But he said the researchers need to find out “which component of the vaccine is causing this response”.

Dr. Jay Butler, a leading infectious disease expert with the Centers for Disease Control and Prevention, said the situation in Alaska showed that the surveillance system was working. The agency has recommended that the vaccine be given in environments where oxygen and adrenaline are available to treat anaphylactic reactions.

Millions of Americans are expected to be vaccinated with the Pfizer vaccine by the end of the year. As of Wednesday evening, it was unclear how many Americans had received it so far. Alex M. Azar II, the secretary for health and human services, said his department would release these data “several days or maybe a week later.”

The Alaska woman’s response was believed to be similar to the anaphylactic reactions two health workers in the UK had after receiving the Pfizer BioNTech vaccine last week. How they both recovered.

These cases are expected to occur Thursday, when FDA scientists are due to meet with the agency’s external panel of experts to decide whether regulators should recommend Moderna’s Covid-19 vaccine for the emergency.

Although the Moderna and Pfizer-BioNTech vaccines are based on the same technology and are similar in their ingredients, it is not clear whether an allergic reaction to one vaccine would occur with the other. Both are made up of genetic material called mRNA, which is trapped in a bubble of oily molecules called lipids, although they use different combinations of lipids.

Dr. Offit said the bladders in both vaccines are coated with a stabilizing molecule called polyethylene glycol, which he saw as a “prime candidate” for causing an allergic reaction. He stressed that further research was needed.

Pfizer’s study did not identify serious adverse events from the vaccine, although many participants experienced pain, fever, and other side effects. The Alaskan reactions were thought to be related to the vaccine because they came on so quickly after the shot.

A Pfizer spokeswoman, Jerica Pitts, said the company doesn’t have all the details of the Alaska situation but is working with local health officials. The vaccine contains information that indicates that medical treatment should be available in the event of a rare anaphylactic event, she said. “We will closely monitor any reports suggestive of serious post-vaccination allergic reactions and update the labeling language as necessary,” said Ms. Pitts.

After workers in the UK fell ill, authorities there warned against giving the vaccines to anyone with a history of severe allergic reactions. They later clarified their concerns and changed the wording of “severe allergic reactions” to mean that the vaccine should not be given to anyone who has ever had an anaphylactic reaction to a food, medicine, or vaccine. That type of response to a vaccine is “very rare,” they said.

Pfizer officials said the two Britons who had the reaction had severe allergies in the past. A 49-year-old woman has had egg allergies in the past. The other, a 40-year-old woman, had a history of allergies to several drugs. Both wore EpiPen-like devices to inject adrenaline in the event of such a reaction.

Pfizer has said that its vaccine does not contain egg ingredients.

The UK update also said a third patient had a “possible allergic reaction” but did not describe it.

In the United States, federal regulators on Friday gave adults ages 16 and older full approval for the vaccine. Healthcare providers have been warned not to give the vaccine to anyone with a “known history of a severe allergic reaction” to any component of the vaccine. This is a standard warning for vaccines.

Due to the UK cases, FDA officials have announced that they will require Pfizer to step up surveillance for anaphylaxis and provide data on it once the vaccine continues to be used. Pfizer also said that it was recommended that the vaccine be given in environments with access to anaphylaxis treatment equipment. Last weekend, the CDC said people with severe allergies could be safely vaccinated, with close monitoring 30 minutes after receiving the shot.

Anaphylaxis can be life-threatening, with difficulty breathing and drops in blood pressure that usually occur within minutes or even seconds of contact with a food or drug or even a substance such as latex that the person is allergic to.

Carl Zimmer contributed to the reporting.

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Trump well being officers talk about Pfizer Covid vaccine as U.S. administers photographs

Trump health officials discuss Pfizer Covid vaccine as U.S. administers shots

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Health Department and Pentagon officials hold a joint briefing on the Trump administration’s Operation Warp Speed ​​Covid-19 vaccination program on Wednesday as Americans begin to receive Pfizer’s shots.

The briefing takes place the day before the FDA Advisory Committee on Vaccines and Related Biological Products votes on whether to recommend Moderna’s emergency vaccine. A positive vote from the committee will likely pave the way for Moderna’s vaccine to be the second approved for use in the United States after Pfizer.

US officials have announced that they will be distributing about 40 million doses of vaccine by the end of this year, enough to vaccinate about 20 million people, since the Moderna and Pfizer vaccines take two weeks two shots apart.

Read CNBC’s live updates for the latest news on the Covid-19 outbreak.

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From Voter Fraud to Vaccine Lies: Misinformation Peddlers Shift Gears

From Voter Fraud to Vaccine Lies: Misinformation Peddlers Shift Gears

The change has been particularly noticeable in the past six weeks. According to an analysis by Zignal, the November 4th election misinformation peaked with 375,000 mentions on cable TV, social media, print and online news. There were 60,000 mentions by December 3. However, the misinformation about coronaviruses increased steadily during this period, rising from 3,900 mentions on November 8 to 46,100 mentions on December 3.

NewsGuard, a start-up fighting false stories, said that of the 145 websites in its Election Misinformation Tracking Center, a database of websites that post incorrect election information, 60 percent also posted misinformation about the coronavirus pandemic . These include right-wing outlets like Breitbart, Newsmax, and One America News Network, which distributed inaccurate articles about the election and are now publishing misleading articles about the vaccines.

NewsGuard’s assistant health editor John Gregory said the postponement is not to be taken lightly as incorrect information about vaccines is causing harm in practice. In the UK in the early 2000s, he said an unfounded link between the measles vaccine and autism frightened people not to take that vaccine. That led to deaths and serious permanent injuries, he said.

“Misinformation creates fear and uncertainty about the vaccine and can reduce the number of people willing to take it,” said Carl Bergstrom, a University of Washington evolutionary biologist who has followed the pandemic.

Dr. Shira Doron, an epidemiologist at Tufts Medical Center, said the consequences of not taking the Covid-19 vaccines due to misinformation would be catastrophic. The vaccines are “the key to ending the pandemic,” she said. “We won’t get there any other way.”

Ms. Powell did not respond to a request for comment.

To deal with misinformation about vaccines, Facebook, Twitter, YouTube, and other social media sites have expanded their guidelines to review and demean such posts. Facebook and YouTube said they would remove false claims about the vaccines, while Twitter directed people to credible public health sources.

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Dec. 16, 2020, 10:29 am ET

In the past few weeks, vaccine truths began to rise as it became clear that coronavirus vaccines would soon be approved and available. Misinformation spreader participated in interviews with health professionals and started twisting them.

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Prisoners have been excluded from Covid vaccine plans

Prisoners have been excluded from Covid vaccine plans

A protester waves a “Black Lives Matter” flag across the street during the demonstration. Representatives from various organizations, including Free the People Roc and HALT (Humane Alternatives to Long-Term), traveled to Elmira correctional facility from across the state to protest the conditions inmates were exposed to during the Covid-19 pandemic. Elmira, NY State Prison has seen a rash of coronavirus cases.

Kit MacAvoy | SOPA pictures | LightRocket via Getty Images

LONDON – The US and UK have already started rolling out their national coronavirus vaccination programs to help contain the spread of the virus. However, health professionals and activists are deeply concerned about the notable lack of prison populations in existing guidelines.

The U.S. Centers for Disease Control and Prevention has not yet made decisions about prisoners regarding access to vaccines, although it is believed that prison staff could be included in the second phase of the allocation. The US CDC was not immediately available for comment when contacted by CNBC.

In the UK, the Joint Vaccination and Immunization Committee has stated that the top priority of the Covid-19 vaccination program should be to prevent death and help maintain health and welfare systems.

The JCVI guidelines do not specifically mention prisons, but it is assumed that the allocation plans will be applied in a manner similar to those in detention.

Both countries have been administering the first vaccinations with the Pfizer BioNTech vaccine outside of the trial conditions in the past few days, raising hopes that mass adoption of safe and effective vaccines could end the coronavirus pandemic soon.

With coronavirus cases and related deaths continuing to surge, experts are questioning the ethics of how governments plan to distribute the first vaccines.

“We face a major dilemma here,” said DeAnna Hoskins, president and CEO of JustLeadershipUSA, a national judiciary reform organization trying to cut the US prison population in half.

Speaking at a webinar at Chatham House earlier this month, Hoskins said people incarcerated are “still fewer than people … and that’s how we react when we talk about vaccine access.”

Covid hotspots

Health officials have for years warned of the dangers of epidemics for detainees, arguing that people are unable to maintain a safe physical distance in correctional facilities due to their confinement in small common areas.

The coronavirus pandemic turned America’s prisons and prisons into Covid hotspots. People in prison are almost four times more likely to be infected than people in the general population – and twice as likely to die, according to a study by a criminal justice commission.

If the biggest trouble spots for Covid are prisons, doesn’t it make sense to vaccinate everyone from guards to prisoners?

Ashish Prashar

Judicial Reform Lawyer

“From my point of view and the information we have, we need to consider where prisoners fit in relation to other high-risk groups in terms of their risk. At first glance, prisoners would be at high risk for several reasons.” Seena Fazel, Department of Psychiatry at Oxford University, said in a report published Dec. 12 in The Lancet Medical Journal.

Fazel said prisoners were at high risk of contracting the coronavirus due to the underlying chronic medical conditions, age and the environment. He cited a systematic review of prison settings by his team that identified correctional facilities as high risk for infectious disease transmission with significant challenges in managing outbreaks.

“Our research suggests that people in prison should be among the first groups to receive a COVID-19 vaccine to protect themselves from infection and prevent the disease from spreading further,” he said.

A view of a new emergency care facility being built to treat COVID-19 infected inmates at San Quentin State Prison on July 8th, 2020 in San Quentin, California.

Justin Sullivan | Getty Images News | Getty Images

The CDC has recommended vaccinating those at an increased risk of infection and mortality for the coronavirus early. However, federal officials say correctional staff should be given priority access to a vaccine, but have not yet spoken out in favor of prisoners being given the same allocation.

Arthur Caplan, a professor of bioethics at New York University’s Grossman School of Medicine, said in the report released by The Lancet that he disagreed with plans to vaccinate prison staff only.

“If you are at risk and older or sick, you should just get vaccinated. If you are in a state where you cannot isolate yourself, you should get vaccinated. I see no reason to distinguish them.”

Racial differences

“If the biggest trouble spots for Covid are prisons, doesn’t it make sense to vaccinate everyone from guards to prisoners?” said Ashish Prashar, a judicial reform attorney and senior director of global communications for Publicis.

Speaking at the December 4th webinar at Chatham House, Prashar said, “All the guards, all health workers, all people going to and out of prison are spreading it to society. Wouldn’t you start on?” Hotspots and stop them? And take care of these people first? “

A nurse holds a sign during a protest by the nurses at Rikers Island Prison about the conditions and threat of the coronavirus on May 7, 2020 in New York City.

Giles Clarke | Getty Images News | Getty Images

Mass incarceration in the United States does not affect all communities equally, as African Americans are disproportionately incarcerated in US correctional facilities.

In addition to racial disparities within the U.S. criminal justice system, an updated CDC report earlier this month found that Hispanics and Black Americans, age-adjusted, were nearly three times more likely to die of complications from the coronavirus than white Americans.

“Half a million people haven’t been convicted of a crime, but we’ve taken their liberty away,” said Celia Ouellette, founder and executive director of the Responsible Business Initiative for Justice, a nonprofit group that advocates greater security about criminal justice systems and security Imprisonment. Her comments related to those in the US who have not been convicted of a crime but are being held in prisons.

“So there is a moral obligation to treat these people just like the surrounding community – or possibly better because they do not have the same access as the surrounding communities.”

“We need to stop thinking of inmate populations as a category of people and see them as people, as we do in the prisons and jail communities,” Ouellette said at the same webinar at Chatham House.