Pfizer Covid-19 vaccine: Who will get it first? How much does it cost? And everything else you need to know
When Pfizer and its partner BioNTech announced on Monday that its experimental coronavirus vaccine is over 90% effective, many questions remained, including when it will be available and for whom initially. On Tuesday, US Secretary of Health and Human Services Alex Azar answered some of these questions, suggesting that there would be enough coronavirus vaccine – including Pfizer’s and potentially others like the one in development by Moderna – to be distributed widely among all Americans by spring 2021. It would, however, be subject to the review process of the US Food and Drug Administration (FDA).
By when can Americans expect a vaccine?
The most vulnerable populations, including nursing home residents, should have access earlier, by the end of December 2020 as Pfizer is preparing to deliver 20 million doses of the vaccine each month, starting by the end of November 2020, said Azar during an interview. Healthcare workers and first responders will be next in line and able to have access to a vaccine by the end of January. Azar said on CNBC that final decisions are subject to a close look at the vaccine efficacy data.
“It’s all dependent on the FDA review process, and it’s going to be as it has been throughout, by the book. But we have contracted with Pfizer for 100 million doses and that will start rolling to us 20 million a month, starting the end of this month. Pfizer’s projected approximately 40 million doses by the end of this year. We will have to look at the data and look at those core target groups. We are thinking of the most vulnerable -- the elderly and nursing homes, assisted living -- and then healthcare workers and first responders -- as those core initial groups that we have received recommendations to focus on. Trying to get them vaccinated whatever the data provides on Pfizer, and if we get Moderna to come in, in the next couple of weeks,” he said.
Azar added, “We have said that we will have enough by the end of this year to vaccinate all of the most vulnerable, by the end of January to vaccinate all senior citizens, as well as first responders and healthcare workers, and then by the end of March-early April enough across all of our vaccine portfolio to have it for every American who would like to be vaccinated. Particulars will depend on seeing that data and seeing where (which population) does it look most effective.”
The National Academies of Sciences, Engineering, and Medicine (NASEM) had recommended that coronavirus vaccines should be rolled out in four phases, with initial supply going to frontline health workers and first responders.
Will it be free?
Americans will receive the Pfizer vaccine for free, consistent with the US government’s ‘commitment’ for free access for Covid-19 vaccines, according to a statement issued by the company in July. The company back then had said that the US government has placed an initial order of 100 million doses for $1.95 billion and can acquire up to 500 million additional doses. Based on current projections, Pfizer expects to produce up to 50 million vaccine doses in 2020 for the whole world, and up to 1.3 billion doses in 2021.
Pfizer plans to submit an Emergency Use Authorization (EUA) request to the FDA after the required safety milestone is achieved, which is currently expected to occur in the third week of November. The FDA then needs to decide whether to give emergency approval based on safety and efficacy data.
Has the Pfizer vaccine been properly tested?
Pfizer’s vaccine trial remains underway. The first interim efficacy analysis was conducted on November 8, 2020, by an external, independent Data Monitoring Committee (DMC). They evaluated 94 confirmed cases of Covid-19 in trial participants. They received two shots of either the vaccine or the placebo and results revealed that the vaccine was more than 90% effective at seven days after the second dose.
“Vaccine candidate was found to be more than 90% effective in preventing Covid-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. As the study continues, the final vaccine efficacy percentage may vary,” stated the November 9 statement.
However, the results were announced via a public release and are yet to be published in a peer-reviewed journal. The companies have not released the data backing up the study, and many experts urged caution before those details have been independently scrutinized. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication. Critical questions regarding how long the protection lasts, if the vaccine protects against both mild and severe coronavirus disease, or lowers the risk of hospitalization and death, and whether it stops virus transmission, remain unanswered.
Researchers also do not yet know what the vaccine’s potential short- and long-term side-effects may be. The DMC, however, has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. “The clinical trial will continue through to final analysis at 164 confirmed cases to collect further data and characterize the vaccine candidate’s performance against other study endpoints,” explained Pfizer. It added, “Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate – the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization – will be available by the third week of November 2020.”
What about other vaccines?
There are more than 150 vaccines in development across the world, 11 of which are in Phase 3 efficacy trials – including one from the US company Moderna, and the Oxford University/AstraZeneca vaccine. The interim results from Moderna’s study are expected soon. Pfizer’s promising results could bode well for Moderna as it uses the same vaccine production technology as Pfizer, known as mRNA, designed to target the same part of the coronavirus.