Today marked a crucial milestone in the U.S. approval process for the coronavirus vaccine developed by Pfizer and BioNTech. On Thursday evening, the Vaccines and Related Biologics Advisory Committee (VRBPAC), made up of virologists and other medical experts, recommended that the Food and Drug Administration issue an emergency use authorization to allow the administration of the vaccine to patients in the United States. . The FDA should follow this recommendation, at which point the vaccine could start rolling out within days.
Here’s what we know about the Pfizer vaccine, including its effectiveness, availability, who will access it first, how much it can cost, and whether it will end the pandemic.
How effective is the vaccine?
Compared to most vaccines, the Pfizer coronavirus vaccine is extremely effective. The FDA has confirmed Pfizer’s finding that its vaccine is 95% effective in protecting recipients from infection with COVID-19. It is much better than the flu shots Americans line up to take a typical fall, which is at most 60% effective.
It was also recently confirmed by the FDA that this efficacy includes prevention severe cases, not just mild or moderate infections.
Equally important, the vaccine shows similar efficacy across age, gender, and racial groups, although subjects in Pfizer’s trial were disproportionately (80%) white, so the data may be incomplete.
The first round of trials did not include recipients under the age of 16 and the vaccine approval schedule for children is currently not clear.
What are the side effects of the vaccine?
Overall, the vaccine has minimal side effects, based on tens of thousands of trial beneficiaries and thousands more already receiving the vaccine in the UK. There have been four reported cases of recipients with Bell’s palsy, an often temporary and non-fatal paralysis of the facial muscles, but the FDA said these events were consistent with the rate in the general population.
Could the vaccine trigger an allergic reaction?
However, two UK health workers with a history of severe allergies had severe reactions after receiving the vaccine. British health authorities advise patients with a similar history to be cautious as they consider the seriousness of the risks.
How many doses of the vaccine will be available after approval?
Initially, very little. Pfizer and U.S. officials currently predict that 40 million doses of the vaccine will reach the United States by the end of 2020. This is enough to deliver the vaccine in two doses to 20 million people, or 6% of the United States population. 80 million more doses, enough for 40 million Americans, will be available in 2021. But because the Trump administration refused to lock down supplementary feed, no dose beyond what should be available until July 2021.
However, that may not be as scary as it sounds, as other vaccine candidates, especially Moderna, are close to Pfizer’s in the approval pipeline.
Who will be eligible to receive the vaccine first?
With so few doses initially available, the Centers for Disease Control recommends prioritizing medical staff and residents of long-term care facilities. But the distribution is managed separately by each state. The CDC has compiled each state vaccine game plan here.
How much will the vaccine cost?
The US government paid Pfizer and BioNTech $ 39 per dose for the first 100 million doses, and Americans would have to pay very little out of pocket to get vaccinated. Medicaid, Medicare and most forms of private insurance will be required by government mandate to cover the cost of vaccinating patients. Even uninsured patients should be able to get vaccinated at little or no cost: special fund was put in place to reimburse providers for these vaccines.
What is an emergency use authorization?
After the advisory committee makes its recommendation today, the FDA is expected to issue an emergency use authorization, or EUA, for the Pfizer vaccine. Basically, this is not a form of FDA approval, but a green light to use the vaccine before it gets full approval. Pfizer will need to continue with the full approval process, including performing further testing.
What is the FDA evaluating?
The FDA has already affirmed its confidence in the test results of Pfizer and BioNTech, and the outcome of today’s advisory committee vote for emergency approval is beyond doubt. The committee has reviewed (and will likely confirm) the findings on the baseline safety and efficacy of the vaccine.
The committee also today discussed the side implications of the emergency clearance, including questions about how to continue with randomized trials after the emergency clearance is approved. But these seem unlikely to be an obstacle to the EUA.
What does the vaccine contain?
Unlike most current vaccines, the Pfizer vaccine does not contain material from the virus it is designed to block. Instead, it contains synthesized Messenger RNA, or mRNA, a kind of genetic cheat sheet that mimics the biology of COVID-19 just enough to train your body’s immune response to fight it. This mRNA is enclosed in an envelope made of lipids, or fat, for delivery.
Why does the Pfizer vaccine require two doses?
Pfizer’s vaccines require two doses, three weeks apart. It is above all to increase its efficiency. The FDA has released data showing that the vaccine is quite effective after a dose, but both doses are needed to develop full immunity.
How long is the vaccine effective?
This is still unknown because the vaccine trials were so recent. The World Health Organization hopes the vaccine will be effective for at least six months. Experts talking to New scientist expect annual booster shots to be necessary.
Can you still transmit COVID after being vaccinated?
Trials of the Pfizer vaccine have measured its safety and effectiveness in preventing symptoms in individuals. He did not determine whether immune people could still carry the coronavirus without showing symptoms. Mario Ostrowsky, professor of immunology at the University of Toronto, said News from CTV in Canada that we will not know whether those vaccinated can be asymptomatic transmitters if infection rates remain high after vaccination of a majority of the population. This means that masks and social distancing will remain the norm even after the vaccine reaches tens of millions of Americans.
Will the vaccine end the pandemic?
Finally, but not immediately. Even though the Pfizer vaccine stops transmission as well as the symptoms, highly infectious diseases like COVID-19 require very high levels of immunity to break the “ chain of transmission ” that can keep an infectious disease circulating in a population. For measles, which is also very contagious, this threshold is 94%. It seems likely that it will take most of next year to achieve this level of COVID immunity in the United States, through a combination of vaccinations and those already infected. Until that happens, the pandemic will not really be over.
More health and Big Pharma coverage of Fortune:
- A depleted workforce with no end in sight: An inside look at the struggling healthcare industry in the United States
- Getting to the COVID-19 finish line: A drama in three acts
- the the science behind the main COVID vaccines will lead to faster manufacturing
- How? ‘Or’ What China’s COVID-19 vaccines could fill the gap leave by Pfizer, Modern, AstraZeneca
- Who receives the first COVID-19 vaccines? Historic UK rollout reveals who has priority