With both Pfizer and Moderna announcing extreme advancements in their Covid-19 vaccines, many are wondering what the next steps will be before they’re distributed to the public.
Pfizer stated this Wednesday that it expects to submit an application for emergency use authorization with the US Food and Drug Administration “within days” after it finalized its Phase 3 clinical trial data. Moderna – the other drug-maker who’s clinical trial data showed its vaccine as being 95% effective – will also be submitting an application within the coming weeks.
Submitting an emergency use authorization (EUA) is the first step to a vaccine being widely distributed throughout the world and slowing this pandemic down. Experts are already projecting that Americans could start receiving their Covid-19 immunizations by the end of December. In typical non-pandemic circumstances, the speed in which a vaccine goes from clinical trial to public distribution can take years, however, the circumstances surrounding this vaccine are obviously rather dire.
Norman Baylor, president and chief executive of Biologics Consulting and former director of the Food and Drug Administration’s Office of Vaccine Research and Review, recently spoke with the media about the extreme precaution everyone involved in this vaccine’s development is taking, especially considering none of them have endured a global health crisis of this magnitude before.
“We are covering new territory. This has never been done before.”
Once Pfizer and Moderna submit their EUA applications to the FDA, approval will still take some time. Following the submission, drug-makers and federal health regulators must complete a series of specific steps and actions before they can approve a vaccine for public manufacturing and distribution.
First and foremost the EUA application will be reviewed by a group of advisers for the FDA. This group is known as the Vaccines and Related Biological Products Advisory Committee, or VRBPAC for short. They’re currently scheduled to meet on December 8th, 9th and 10th, during which they will likely review Pfizer’s application and Moderna’s depending on when they submit theirs.
To clarify, VRBPAC are not employed by the FDA, and are instead independent experts who in their daily lives work as scientists, physicians, infectious disease experts, and consumer representatives. If the group reviews all the data and votes in favor of the vaccines distribution, the FDA will then consider whether or not to accept the advisory committee’s recommendations, and if they do, they’ll issue the EUA. Dr. Paul Offit, a vaccine researcher at the Children’s Hospital of Philadelphia, is a member of the VRBPAC who recently spoke with the press about his hopefulness for these vaccines in general.
“This is going to happen in rapid succession, I suspect. If I had to make a guess, I think this all happens in the first few weeks of December.”
If the FDA grants the Pfizer or Moderna vaccine with an EUA, an advisory committee to the Centers for Disease Control and Prevention (CDC) will then decide what groups should be the first in line to receive the vaccine. That advisory committee is called the Advisory Committee on Immunization Practices, or ACIP, and they’re currently scheduled to have a preliminary Covid-19 vaccine meeting on Monday (November 23rd).
It’s unlikely that ACIP will vote at this meeting, especially considering neither vaccine has received an EUA yet, however, it’s important for them to start planning now, as we’ve seen this process is going to continue to move quickly. When the group does reach a decision, the CDC will then consider those recommendations and then create a concrete finalized plan for distribution.
It’s expected that doctors, nurses, and other healthcare workers on the frontlines of this pandemic will receive the vaccine first followed by elderly individuals and people who are immunocompromised and at a greater risk of developing Covid-19 complications/severe symptoms. The general public should expect to receive a vaccine around spring/summer 2021.
Experts also suspect once the FDA and CDC committee’s make their decisions, the two government agencies will only take a few days to finalize the process and begin vaccinating as a means of finally slowing this pandemic down and getting life back to normal.
Eric Mastrota is a Contributing Editor at The National Digest based in New York. A graduate of SUNY New Paltz, he reports on world news, culture, and lifestyle. You can reach him at firstname.lastname@example.org.