F.D.A. Clears Moderna’s Covid Vaccine

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

The Food and Drug Administration on Friday approved the emergency coronavirus vaccine manufactured by Moderna, which will allow millions more doses to be shipped across the country and intensify the debate over who should be vaccinated next.

This will make Moderna's vaccine the second to reach the American public after the Pfizer and BioNTech vaccine that was approved just a week ago.

The FDA's decision sets the stage for a weekend spectacle with trucks, which, as committees of experts, initiate a new panel of discussions that weighs up whether the next wave of vaccinations should go to key workers or to people aged 65 and over and people with these conditions increase their risk to get seriously ill from Covid-19.

Jockeying for the next shots in January and February has already begun, although there are still not enough of the two vaccines for all health care and nursing home workers and residents who are given first priority. Uber drivers, restaurant workers, undertakers and hairdressers are among the lobbying states they are moving to the next round, along with those in the more traditional categories of the country's 80 million key workers, such as teachers and bus drivers.

The rapid progress from laboratory to human trials to public vaccination has been almost revolutionary, reflecting the urgent need for the country to mitigate the pandemic that has broken record after record in deaths, hospitalizations and economic losses in the US. In the last week alone, there was an average of 213,165 cases per day, an 18 percent increase from the average two weeks earlier. And the daily death toll in the past few days has exceeded 3,200.

Dr. Anthony S. Fauci, the nation's leading expert on infectious diseases, said in an interview on Friday evening that the advent of two vaccines was "a historic moment".

“To me, this is a triumph of multi-year investment in biomedical research that culminated in something not just done in record time, in the sense that no one has ever thought that you could get vaccines against humans in less than a year would have the sequence announced, "said Dr. Fauci.

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

Moderna, a Cambridge, Massachusetts-based company, worked with Dr. Fauci's agency at the National Institutes of Health to develop a vaccine that works with Pfizer-BioNTech to develop a new technology based on genetic material called messenger RNA, or mRNA. In clinical studies on tens of thousands of volunteers, the vaccines were 94 to 95 percent effective. Each requires two shots.

Both products reach an anxious public before vaccines are made using traditional approaches and have become even more critical as other companies' efforts have stalled in recent months.

The emergency clearance kicks off a rapid and complex initiative to distribute approximately 5.9 million doses of the Moderna vaccine across the country. Shipping starts on Sunday and delivery starts on Monday. The first Moderna vaccinations could then be given hours later.

Because Moderna's vaccine, unlike Pfizer-BioNTech, does not require extremely cold storage and is shipped in smaller quantities, states are hoping to ship it to less populated areas and reach rural hospitals, local health departments, and community health centers that are not in the Proximity was high on the mailing list.

Three places that haven't received the Pfizer BioNTech vaccine – the Marshall Islands, Micronesia, and Palau – will receive the Moderna vaccine because of this, according to a federal health official familiar with the government's distribution plans.

And unlike Pfizer's launch last week, Moderna vaccine shipments are being managed by the federal government as part of Operation Warp Speed, the administration's program to develop and distribute vaccines as quickly as possible.

The supply of a second vaccine cannot come early enough. Several governors and state health officials said Friday they were dismayed to learn they would receive less of the Pfizer BioNTech vaccine next week than the federal government had promised.

Dr. Mark Levine, commissioner for the Vermont Department of Health, said in a briefing Friday, “All of my colleagues in the area report a 25 to 35 percent decrease in their allocation for the next week. When we walked in, I learned that 975 cans out of an expected 5,850 cans would not come when we expected it. That doesn't mean we don't all get these doses. It just means they won't come when we expected them to. "

He added, "What everyone around the country is upset about is that there is no communication besides the number, so no understanding of what this really means."

Massachusetts Governor Charlie Baker said Friday, "We are certainly frustrated," referring to the reduced number of Pfizer BioNTech cans his state would receive next week – 42,900 instead of 59,000. The demand for the vaccine is high.

"In order to So far, hospitals have reported overwhelming acceptance by doctors, nurses and other workers who are eligible to vaccinate, ”he said.

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 when society as a whole receives enough protection against the coronavirus. Once countries approve 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 for people to spread the virus without knowing they are infected because they have mild or no symptoms. 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 normal life from 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. However, it is unclear whether the virus can bloom and sneeze or exhale in the nose to infect others, even if antibodies have been mobilized elsewhere in the body to prevent the vaccinated person from getting 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.

Pointing out the badly hit Wisconsin, Governor Tony Evers complained that the state was receiving significantly less Pfizer BioNTech vaccine than 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 vaccines immediately."

Since Moderna's vaccine requires two doses, federal officials hold an additional 5.9 million doses ready for shipment four weeks after the first wave, as the doses are a month apart. The federal government is also planning to reserve more than 500,000 cans in the event of problems with the first delivery.

Officials expect to inform states next week of the number of cans they want to ship in the second wave of shipments.

Friday's emergency clearance was the product of an F.D.A. Review process that compressed an extraordinary amount of work into weeks and occurred simultaneously while regulators pondered materials for the Pfizer BioNTech vaccine.

The overlap created a stressful schedule for the reviewers. Large teams organized around subject areas – including epidemiology, statistics, and manufacturing – and reviewed Moderna's application day and night after the company submitted its data in late November.

Components of the review included teams examining the company's manufacturing facilities and clinical trial sites to confirm that the records matched the materials Moderna had submitted to federal agencies.

Above the F.D.A. For the past few weeks, there has been a prospect of political influence over the Agency's review of both vaccines. President Trump has Dr. Stephen M. Hahn, the F.D.A. Commissioner to expedite the authorization.

Dr. Hahn tried on Friday to distance the agency from any perceived interference.

"We worked quickly based on the urgency of this global pandemic, not due to external pressure," he said at a press conference shortly after the approval was announced. "We have not made any compromises, but cut bureaucracy, which can sometimes slow down the process."

The advisory board of the F.D.A. Also had to consider new information – reports of severe allergic reactions, two in the UK and two in the US, in people who received the Pfizer BioNTech vaccine after it was approved. Although this vaccine is not the same as Moderna's, they are similar. The agency and Centers for Disease Control and Prevention are investigating the cases, but say the vaccines are safe to give to most allergy sufferers under close supervision.

In the Friday night briefing, the F.D.A.'s chief vaccine regulator, Dr. Peter Marks reported that around five cases have been investigated across the country.

Dr. Marks said it was "dangerous" for him to speculate on the cause of the reactions, but mentioned a possible link between rare allergic reactions and polyethylene glycol, a component of both vaccines, but in different formulations. The reactions occurred in people who received the Pfizer vaccine in the first few weeks of a public rollout.

The approval of the F.D.A. was also a keystone to a far-reaching, government-led effort that began in January when scientists from N.I.H. and Moderna designed the vaccine within two days of China's release of the genetic sequence of the new virus.

The company had never launched a product before, which earned it underdog status as its vaccine was tested on the same schedule as that of Pfizer-BioNTech. Moderna had an unusually close relationship with Operation Warp Speed, which has been monitoring supplies almost every hour this year. The company benefited from nearly $ 2.5 billion in federal funding used to purchase raw materials, expand its factory, and expand its workforce 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 are successful in studies and receive emergency approval.

The federal government is anticipating vaccine building materials being developed by several others – one by Johnson & Johnson, one by Sanofi in France and GlaxoSmithKline in the UK, and one by the Anglo-Swedish drug maker AstraZeneca and Oxford University.

On Saturday and Sunday, experts advise the C.D.C. will pick up Moderna's vaccine and ultimately vote on the next levels of people to receive the vaccines. Sunday's committee vote will most likely spark a series of difficult decisions at the state level, which could be complicated by bumps in the vaccine production process.

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

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

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

McKesson also makes kits that contain the consumables needed to deliver both vaccines.

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

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

Each kit contains needles, syringes, alcohol supplements, face shields and surgical masks, administration sheets for healthcare providers, and vaccination protocols and reminder cards for patients.

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

When the time comes to ship the Moderna cans, McKesson will pack the cans in coolers obtained from Cold Chain Technologies, a Franklin, Massachusetts company. These coolers are packaged with coolant packs and then shipped to the administrative locations via FedEx and UPS. The coolers also contain monitors that will show if the vaccines have ever got too warm.

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

David Gelles, Katherine J. Wu, Sharon LaFraniere, and Reed Epstein contributed to the coverage.

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