While U.S. President Donald Trump has repeatedly claimed that a COVID-19 vaccine would be available by mid-October , days before the November 3 presidential election, the guidance for ‘Emergency Use Authorization for Vaccines to Prevent COVID-19’ , released by the U.S. Food and Drug Administration (FDA), has dashed that possibility. The FDA has made it clear that “data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile.” However, the guidance for industry contains non-binding recommendations.
Shutting the door
With at least two months of follow-up data likely to become available at the earliest only by November or December, the guidance essentially shuts the door on vaccine manufacturers making their vaccines available for public use through the emergency use authorisation route before election day. Dr. Albert Bourla, Chairman and CEO of Pfizer, had on earlier occasions said that the company may have vaccine data ready to submit to the FDA in October.
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The FDA guidance comes after the White House had blocked its release due to concerns that the guidelines would delay the arrival of the first dose until after election day. Even as Mr. Trump called the FDA guidance release as “just another political hit job”, Dr. Peter Marks from FDA’s Center for Biologics Evaluation and Research told CNN that “being open and clear about the circumstances” under which emergency use authorisation will be issued for COVID-19 vaccines is “critical to building public confidence and ensuring the use of COVID-19 vaccines once available”. He added that the FDA hopes that the guidance on COVID-19 vaccines “helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorised or approved”.
The unprecedented speed at which COVID-19 vaccines have progressed to Phase 3 trials and the haste shown by the Trump administration to get a vaccine out before election day have eroded public trust in COVID-19 vaccines that are undergoing trials. A Gallup COVID-19 tracking survey carried out in the U.S. between July 20 and August 2 found that 35% of Americans did not want to be vaccinated even if an approved vaccine was available at no cost. Similarly, CNN polls found the percentage of people willing to be vaccinated dropping from 66% in May to 51% in October. People unwilling to be vaccinated include those who are otherwise inclined towards vaccines.
Building trust
The FDA’s initiative to build public trust in COVID-19 vaccines is one of the many steps taken by stakeholders to address the concerns about new vaccines developed and tested at speeds unknown before. In September, nine vaccine manufacturers came together to sign a joint pledge to assure the public that they would develop and test COVID-19 vaccines in accordance with “high ethical standards and sound scientific principles” and always keep the “safety and well-being of vaccinated individuals the top priority”. They clarified that they would not seek premature approval from regulatory authorities.
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In an unprecedented move, three pharma companies — Moderna, Pfizer, AstraZeneca — published the Phase 3 trial protocols to inform the public and scientists about the evidence companies will use to determine if vaccines are effective.
Finally, in an open letter to colleagues, Pfizer’s Dr. Bourla said he “can’t predict exactly when, or even if our vaccine will be approved by the FDA”, and that the “world will be safer if we stop talking about the vaccines’ delivery in political terms.” He wrote: “Let’s continue to work together to build trust in science. Imagine the compounded tragedy if we have a safe and effective vaccine that many people didn’t trust. That is a risk none of us should accept.”
That the FDA is not buckling under pressure from the Trump administration for quick clearance may go some way in winning back the trust that people are losing in COVID-19 vaccines.
R. Prasad is the Science Editor of The Hindu
Published - October 09, 2020 12:15 am IST
