FDA to fast track development of two COVID-19 vaccines from Pfizer and BioNTech
Two of Pfizer and BioNTech’s potential COVID-19 vaccines have been granted Fast Track status by the FDA, a process designed to hasten their development and review.
Fast Track status is reserved for new drugs and vaccines that aim to treat or prevent serious conditions, for which there are few or no alternative therapies.
The companies said that the FDA has selected the two most advanced of the four mRNA-based vaccines, BNT162b1 and BNT162b2.
This designation was granted based on preliminary data from phase 1/2 studies that are ongoing in the US and Germany as well as animal immunogenicity studies.
The companies released early data from the ongoing US phase 1/2 study for BNT162b1 at the beginning of the month.
The companies used the data to help select a candidate to develop in a phase 2b/3 safety and efficacy trial, which could involve up to 30,000 people and may begin in the coming weeks if regulators give the go-ahead.
That data from BNT162b1 came from the first part of the study, which included 45 healthy adults aged 18 to 55.
Preliminary data came from 24 people who received two lower-dose injections, 12 who received a higher dose, and nine who received two doses of placebo control.
At day 28, all those on the lower dose had significantly elevated numbers of antibodies capable of binding with the coronavirus,
A separate test conducted on day 28 showed antibodies from the low dose group were able to neutralise the SARS-CoV-2 virus.
Each vaccine has a unique combination of mRNA format and target antigen, and BNT162b1 contains an optimised SARS-CoV-2 receptor binding domain antigen.
The companies said that local reactions and systemic events in the low dose group were “mild to moderate” and transient with no serious adverse events reported.
The 12 people who received the higher dose had elevated levels of binding antibodies but levels of neutralising antibodies were lower than those in a control serum sample.
There are now 21 potential coronavirus vaccines in clinical development and more than a hundred more in preclinical development, according to a list maintained by the World Health Organization.
Potential vaccines from Sinovac and AstraZeneca/University of Oxford are at the top of the list, having already made it through to phase 3 clinical trials.
