With at least two months follow-up data likely to be available earliest only by November or December, the guidance essentially shuts the door on vaccine manufacturers making their vaccines available for public use through an emergency use authorisation route before the election day.

While U.S. President Donald Trump has repeatedly claimed that a COVID-19 vaccine will become available during the month of October days before the November 3 presidential election, the guidance for Emergency use authorisation of COVID-19 vaccines released by the U.S. Food and Drug Administration on October 6 has dashed that possibility.

While U.S. President Donald Trump repeatedly claimed that a COVID-19 vaccine will become available during the month of October days before the November 3 presidential election, the guidance for Emergency use authorisation of COVID-19 vaccines released by the U.S. Food and Drug Administration on October 6 has dashed that possibility.

In the guidance to industry, the FDA has made it clear that it will want data from a “median follow-up duration of at least two months after completion of the full vaccination regimen” in the Phase-3 trial. The insistence of at least two months follow-up data from the day of second dose of vaccination is to help provide the agency with “adequate information to assess a vaccine’s benefit-risk profile”.

With at least two months follow-up data likely to be available earliest only by November or December, the guidance essentially shuts the door on vaccine manufacturers making their vaccines available for public use through an emergency use authorisation route before the election day. Dr. Albert Bourla, Chairman and CEO of Pfizer had on earlier occasions said that the company could have vaccine data ready to submit to the FDA in October.

The FDA guidance comes after the White House had earlier blocked its release due to its concerns that the guidelines would delay the arrival of the first doses until after Election Day.

FDA’s assurance of a safe vaccine

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 authorization will be issued for COVID-19 vaccines is “critical to building public confidence and ensuring the use of COVID-19 vaccines once available”. He further added that 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”.

Dr. Stephen Hahn, the FDA commissioner has also weighed in on vaccine safety saying: “We will use science and data to drive those decisions, we will be transparent about those decisions, and we will do everything in our power to prevent anything other than science and data from being involved in those decisions. That is the promise that we as the FDA, that I as the commissioner of food and drugs, make to the American people.” He also added: “None of us, including most importantly our career scientists, would want a vaccine approved or authorized that we wouldn’t give to ourselves or our families.”

The unprecedented speed at which vaccines against novel coronavirus has progressed to Phase-3 trials together with the haste shown by the Trump administration to get a vaccine out before election day has eroded public trust in COVID-19 vaccines undergoing trials.  

Increase in COVID-19 vaccine hesitancy

A Gallup COVID-19 tracking survey carried out 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 has been steadily dropping — 66% in May, 56% in August, and 51% in October. People unwilling to be vaccinated include those who are otherwise favourably disposed to vaccines. For instance, Dr. Tom Frieden, former director CDC said: “I’ll feel comfortable getting a vaccination if it goes through the full CDC and FDA processes and is approved based on clear and transparent data.”

Steps taken to win back trust in COVID-19 vaccines

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 vaccines developed and tested at speeds unknown before. First, nine vaccine manufacturers came together to sign a joint pledge saying 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 our top priority”. They assured that they would not seek premature approval from regulatory authorities.

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 that companies will use to determine if vaccines are effective.

Finally, on October 1, 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… the world will be safer if we stop talking about the vaccines’ delivery in political terms. 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”.

Dr. Hahn assured that “Science will guide our decision, and I will not, and the FDA will not, allow pressure from anybody to change that”. The FDA not buckling under pressure from the Trump administration for an accelerated clearance may hopefully go some way to win back the lost trust in COVID-19 vaccines.

Published in The Hindu on October 9, 2020