KUALA LUMPUR, Dec 11 — A panel of external experts voted yesterday to recommend an emergency-use authorisation (EUA) of the Pfizer-BioNTech Covid-19 vaccine to the United States’ Food and Drug Administration (FDA).
With this recommendation by members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), the FDA will likely grant an EUA to the vaccine by US pharmaceutical company Pfizer and its German partner, BioNTech, within days, STAT reported.
FDA scientists have earlier found the Pfizer vaccine to be safe and 95 per cent effective in preventing symptomatic Covid-19.
According to CNN, FDA staff feel the responsibility to speed up the review process, but at the same time, to carry out their mandate to protect the public’s health to ensure that any authorised vaccine meets their standards for safety and effectiveness.
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunisation Practices is scheduled for a meeting today and expects to vote whether it recommends that the vaccine can be deployed for use on Sunday.
Officials from the US’ Operation Warp Speed — which aims to produce and deliver 300 million vaccine doses — said that they will start shipping the Covid-19 vaccine within 24 hours of the FDA authorisation.
Currently, the Pfizer-BioNTech Covid-19 vaccine has not been tested on pregnant and lactating women.
However, Pfizer told the expert meeting yesterday that it expects, by mid-December, preliminary results from its developmental and reproductive toxicity (DART) studies that are done in animals to see if the vaccine harms a developing foetus, or poses threats to pregnancy.
Trials will still have to be done on pregnant and lactating women before a specific EUA from FDA is released for the vaccine to be used on these populations.
CDC estimated that about 330,000 health care workers, who are at top priority in getting the vaccine, are either pregnant or lactating.
During the meeting on Thursday with the Vaccines and Related Biological Products Advisory Committee (VRBPAC), there were several issues discussed, including vaccinating people with severe allergies, STAT reported.
Children’s Hospital of Philadelphia vaccinologist Paul Offit, who was a panelist at yesterday’s meeting, pointed out that the fact that two people in the UK, who received the vaccine developed severe allergic reactions, was potentially a big problem.
This could mean, according to him, that many Americans with a medical history of severe allergies would be afraid to get the vaccine.
Offit urged Pfizer-BioNTech to study the vaccine in people with a history of common allergies and had also asked the FDA what it planned to do.
Moreover, he pointed out that the vaccine, which had the longest chemical names that he’d ever seen, would give troubles to the patient in identifying potential allergens from the ingredients list.
Offering Placebo Groups Covid-19 Vaccine After EUA
Pfizer has been persistent in wanting to give their placebo recipients the vaccine. However, the FDA wants the clinical trials to generate as much placebo-controlled data as possible.
STAT reported Steven Goodman, an associate dean of the clinical and translational research at Stanford University School of Medicine, as saying that vaccinating all placebo recipients after the EUA would allow trial volunteers from the placebo group to jump the queue ahead of people who are considered the high-risk groups.
Pfizer said that they have developed a protocol amendment that is subject to input and alignment with regulatory authorities, but designed so that all interested participants 16 years and older in the placebo group would have the option to receive the vaccine at scheduled time points.
Monitoring The Vaccine’s Safety And Efficacy After Authorisation
CDC is currently creating a large database which will allow it to track adverse events and try to determine if those effects are from the vaccine.
This database will include the Vaccine Adverse Events Reporting System run by CDC and the FDA.
Meanwhile, the vaccine efficacy will be tracked firstly among health care workers, followed by those severely affected or hospitalised patients, the elderly and those in long-term care facilities, and those with key underlying conditions among other groups.