The Food and Drug Administration authorized Pfizer’s Friday emergency Covid-19 vaccine paves the way for millions of people at high risk to start the vaccine within days.
The approval marks a historic turning point in a pandemic that killed more than 290,000 people in the United States. The decision makes the United States the sixth country to approve the vaccine, alongside the United Kingdom, Bahrain, Canada, Saudi Arabia and Mexico. Further approvals, also from the European Union, are expected within weeks.
The decision of the F.D.A. followed an extraordinary series of events on Friday morning when White House Chief of Staff Mark Meadows presented the F.D.A. Commissioner Dr. Stephen Hahn, considering looking for his next job if he didn’t get the emergency permit on Friday, according to a senior administration official who spoke on condition of anonymity because he was not empowered to discuss the matter. Dr. Hahn then ordered the agency’s vaccine regulators to do so by the end of the day.
The approval sparked an intricate coordination effort by Pfizer, private shipping companies, state and local health officials, the military, hospitals, and pharmacy chains to get approximately three million doses to health care workers and nursing homes as quickly as possible during the first week Vaccine is kept at ultra-cold temperatures.
Pfizer has signed a contract with the US government to supply 100 million doses of the vaccine by March next. As part of this agreement, the recordings are free to the public.
Each state, along with six major cities, has presented the federal government with a list of locations – mainly hospitals – where the Pfizer vaccine will initially be shipped. The first recipients will be in populous Florida five hospitals, in Jacksonville, Miami, Orlando, Tampa and Hollywood. In tiny rural Vermont, only the University of Vermont Medical Center and a state warehouse are serviced.
McKesson Corporation, a giant medical supplier, is sending kits of syringes, alcohol swabs, face shields, and other consumables to the same locations where they meet with the vaccines that Pfizer ships in special boxes packed with dry ice to keep them at minus 94 degrees Fahrenheit .
The Pfizer packaging contains a device that detects the location of the box, as well as a thermal probe that ensures that the freezer is maintained throughout the journey from the company’s sales offices in Michigan and Wisconsin.
The decision is a victory for Pfizer and its German partner BioNTech, who started work on the vaccine 11 months ago. Vaccines usually take years to develop. The late-stage clinical study of the companies, involving nearly 44,000 people, was 95 percent effective.
A panel of experts that the F.D.A. announced on Thursday the approval of the Pfizer vaccine for people aged 16 and over, and the agency planned to release the formal approval on Saturday. That deadline was cut by half a day after President Trump found Dr. Hahn attacked for not approving a vaccine any sooner. However, the accelerated announcement was not expected to speed up vaccine delivery across the country.
Mr. Trump said Dr. Hahn on Twitter on Friday morning to “stop playing and save lives !!!” He called the F.D.A. “A big, old, slow turtle”, full of money but full of red tape.
Mr Trump has repeatedly received the F.D.A. and the drug manufacturers themselves have been slow to go through the licensing process in order to politically harm it. The allies of Dr. Hahn have been on the bend for weeks and expect to be fired every day.
The president wrote that with “my urging” the government had cut vaccine development by years. “Get the dam vaccines out NOW, Dr. Hahn,” he wrote, mistyping the phrase.
The threat to Dr. Hahn’s job was first reported by the Washington Post. In a statement, Dr. Hahn that Mr. Meadows told him to consider finding another job and called him “a false representation of the phone call”. Instead, says Dr. Hahn, his agency was “encouraged to continue working quickly.”
Although the F.D.A. Some experts warned that the Pfizer vaccine would definitely be approved White House pressure could undermine public confidence in the agency’s decision-making.
“This can actually do more harm than good because all it will do is put more politics into a scientific process,” said Dr. Aaron S. Kesselheim, Professor at Brigham and Women’s Hospital and Harvard Medical School.
A similar vaccine developed by Moderna is currently being used by the F.D.A. and could soon be released for emergencies. On Friday, the federal government announced that it had ordered an additional 100 million cans from Moderna, adding to an initial supply agreement of 100 million cans this summer. Other vaccines, including those developed by Johnson & Johnson and AstraZeneca, are in late-stage trials and could be approved in the next few months.
In anticipation of the vaccine’s arrival across the country, Americans expressed both hope and concern.
Dr. Samu Queen, a doctor in Portland, Oregon, said her geriatric patients are especially excited about the vaccine. “They are all very concerned,” she said. “Pretty much everyone is ready to get it at any appointment.”
As the coronavirus vaccine nears U.S. approval, here are some questions you may be wondering about:
- If I live in the US, when can I get the vaccine? While the exact order of vaccine recipients may vary from state to state, most doctors and residents of long-term care facilities will come first. If you want to understand how this decision is made, this article will help.
- When can I get back to normal life after the vaccination? Life will not return to normal until 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 a normal state in autumn 2021.
- Do I still have to wear a mask after the vaccination? Yeah, but not forever. The two vaccines that may be approved this month clearly protect people from contracting Covid-19. However, the clinical trials that produced these results were not designed to determine whether vaccinated people could still spread the coronavirus without developing symptoms. That remains a possibility. We know that people who are naturally infected with the coronavirus can spread it while they don’t have a cough or other symptoms. Researchers will study this question intensively when the vaccines are introduced. In the meantime, self-vaccinated people need to think of themselves as potential spreaders.
- Will it hurt What are the side effects? The vaccine against Pfizer and BioNTech, like other typical vaccines, is delivered as a shot in the arm. The injection is no different from the ones you received before. Tens of thousands of people have already received the vaccines, and none of them have reported serious health problems. However, some of them have experienced short-lived symptoms, including pain and flu-like symptoms that usually last a day. It is possible that after the second shot, people will have to plan to take a day off or go to school. While these experiences are not pleasant, they are a good sign: they are the result of your own immune system’s encounter with the vaccine and a strong reaction that ensures lasting immunity.
- Will mRNA vaccines change my genes? No. Moderna and Pfizer vaccines use a genetic molecule to boost the immune system. This molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse with a cell, allowing the molecule to slide inside. The cell uses the mRNA to make proteins from the coronavirus that can stimulate the immune system. At any given point in time, 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 for 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.
Dr. Queen said she was watching closely how the UK’s first subjects reacted. She described herself as “a little concerned about how safe it is as opposed to not”.
Joshua Ball, assistant director of Shaping Our Appalachian Region, an eastern Kentucky business development group, was a primary caregiver to his father, who had a stroke and other health issues earlier this year. During the pandemic, he had to try to help remotely as much as possible.
A vaccine could change that. It could also allow him to return to church and participate in the seasonal festivals that are a cultural staple for many small towns in his area.
“I miss the community, shaking hands, seeing people, celebrating birthdays, church meals, and a holiday Bible school,” he said.
Still, state health officials remain deeply concerned about what they call insufficient funding for the largest vaccination campaign the country has ever launched. State health officials have asked Congress for at least $ 8.4 billion to do the job well. So far, however, they have only received about $ 350 million from the Centers for Disease Control and Prevention for vaccine distribution and administration. These tasks include expanding online systems to track and share information about who has been vaccinated. Recruitment and training of doctors, nurses and pharmacists to manage admissions; and convince the public of the importance of getting vaccinated.
Adequate supply of the vaccine has also proven to be a challenge with no clear solution. Pfizer had to cut previous estimates due to manufacturing setbacks and has announced it will deliver up to 25 million doses by the end of the year and a total of 100 million vaccines by March.
This week, federal officials said that instead of all 6.4 million doses the government originally ordered from Pfizer to vaccinate people, half of the offer will be withheld for a booster shot to recipients three weeks after their first vaccination. Although only about three million people will receive a vaccine in the first week, officials have confirmed their estimate that between Pfizer and Moderna vaccines, which require two shots each, they hope to give at least 20 million people their first vaccine to be able to dose a vaccine by the end of the year.
Questions also remain about how soon a vaccine will be available to anyone who wants one. Federal officials have announced that they are expected to vaccinate most of the US population by the middle of next year, but recent setbacks have challenged those estimates. Pfizer has told the federal government that due to agreements with other countries, it may not be able to deliver an additional 100 million doses to the United States before the middle of next year. Three other experimental vaccines developed by Novavax, Sanofi and AstraZeneca have suffered delays in their clinical trials.
Ellen Barry and Will Wright contributed to the coverage.