Column by Dr. Richard Sternberg
On Wednesday August 31 the FDA authorized, for emergency use, two new, bivalent, COVID vaccines. Bivalent means that each shot contains two variants of the vaccine. The following day the CDC Advisory Committee on Immunization Practices’ (ACIP) recommended the use of those vaccines and the same day, CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the committee’s recommendations for use of updated COVID-19 boosters from Pfizer-BioNTech for people ages 12 years and older, and from Moderna for people ages 18 years and older. Updated COVID-19 boosters add Omicron BA.4 and BA.5 spike protein components to the current vaccine composition, helping to restore protection that has waned since previous vaccination by targeting variants that are more transmissible and able to avoid immune responses.
Currently about 89% of circulating virus in the United States is Omicron BA.5 and almost all the rest is BA.4 and BA.4.6. Both vaccines are RNA types, that is it gets the body’s cells to manufacture antibodies to the COVID virus spike protein but do not affect the body’s cell’s DNA. The virus itself does not make up these vaccines unlike the case with polio, which is either dead virus or live-attenuated virus (see this column’s article of September 24.)
The vaccines are already available in some locations and should be widely available before the end of the month. President Biden has announced that the Federal government has purchased over 170 million doses for distribution. It is expected that the CDC will soon also recommend the new boosters for other pediatric groups.
The CDC stated that “the Food and Drug Administration’s (FDA) authorization of updated COVID-19 boosters, and CDC’s recommendation for use, are critical next steps forward in our country’s vaccination program — a program that has helped provide increased protection against COVID-19 disease and death.”
The updated boosters are currently only for people who previously had an initial course of vaccine. A full course of vaccination with boosters so far has been attributed with decreasing the risk of dying from COVID by 90% or greater according to the New England Journal of Medicine.
Dr. Walensky issued the following statement on September 1 “The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant. They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to do that.”
There is controversy about the new boosters against BA.4 and .5. While new boosters for BA.1 have been tested in humans some people are critical that the new boosters haven’t.
Vaccine manufacturers had submitted data to the FDA on a vaccine for BA.1 earlier in the year but the virus hasn’t stood still and continued to mutate, so the FDA asked them to update their vaccines to include and cover the most recent variants, Omicron BA.4 and BA.5. It has been argued by many virus and vaccine scientists that this change in subtype is completely equivalent to what happens with influenza vaccines every year. This will be the first update to the mRNA vaccines since they became available in December 2020.
One advantage the U.S. has against COVID is that it has been hypothesized that almost all of the population has been vaccinated or had the disease or both, giving them some protection from having severe illness and death, but risks can be further decreased, and our ability to minimize restrictions increased by getting these updated vaccines which like the flu vaccine may end up being annual or even more often.
Dr. Richard Sternberg, retired Bassett Hospital orthopedic surgeon, is providing his professional perspective during the COVID-19 threat. Also a village trustee, he lives in Cooperstown.