Three long-time FDA officials, Dr. Peter Marks, Dr. Janet Woodcock and Dr. Robert Califf wrote an op-ed in JAMA describing the reality that COVID-19 represents “the new normal.”
Al Drago/CQ Roll Call
Three long-time U.S. Food and Drug Administration officials, Dr. Peter Marks, M.D., Ph.D., Dr. Janet Woodcock, M.D. and Dr. Robert Califf, M.D., wrote an op-ed in JAMA describing the reality that COVID-19 is unlikely to go away and that it represents “the new normal.”
Marks is the director of the FDA’s Center for Biologics Evaluation and Research; Woodcock is a former commissioner, currently principal deputy commissioner; Califf is currently commissioner.
“It will likely circulate globally for the foreseeable future,” they write, “taking its place alongside other common respiratory viruses such as influenza. And it likely will require similar annual consideration for vaccine composition updates in consultation with the data-driven FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC).”
In fact, the FDA and VRBPAC met on April 6 to discuss many of those considerations. They cite significant data, showing that a third dose of the mRNA COVID-19 vaccines from Pfizer-BioNTech and Moderna, provides durable protection against hospitalization and death, yet only 45% of the U.S. population has received the third shot, including only about 68% of people older than 65 years, who are at the greatest risk.
They note that the fourth dose was only recently authorized, so data is not yet available on how protective it is against serious outcomes in the U.S. However, data in Israel suggested it demonstrated additional protection in people 50 years and older.
They state that in addition to needing to determine how many doses and when they should be taken, the actual future composition of the COVID-19 vaccine is under discussion. They write, “To provide maximal benefit across the entire age spectrum, careful consideration will need to be given to the choice of the SARS-CoV-2 variant(s) to cover in the COVID-19 vaccines for the fall and winter of the 2022-2023 season. This is because the variant(s) covered by the vaccine may have an important influence on both the extent and duration of protection against a future SARS-COV-2 variant(s) that may circulate.”
Pfizer noted in its first-quarter financial report Tuesday that it is evaluating its vaccine for emerging variants of concern. Moderna has an ongoing Phase II trial of its bivalent booster shot that combines the Omicron-specific booster candidate with the prototype vaccine.
At the recent meeting of the VRBPAC, the committee mostly agreed that a single vaccine composition used by all manufacturers was desirable and it should be data-driven. They also emphasized the composition should be based “on the totality of the available clinical and epidemiologic evidence, optimally it could be used for both primary vaccination as well as booster administration.”
They hope any such updated COVID-19 vaccine would be available to be dosed with the seasonal influenza vaccine in the Northern Hemisphere starting in about October. They expect a decision will be made in the U.S. by June 2022.
The authors point out, “As plans are being developed for the coming fall and winter, it is critical that patients and caregivers understand the profound benefit of a booster dose of the mRNA vaccines or a second vaccine dose of any kind after the Janssen/Johnson & Johnson vaccine and that this understanding leads to action now in the face of a current uptick in infection rates. Clinicians should not be susceptible to inertia and should continue to recommend that patients get their COVID-19 vaccination status up to date, meaning primary vaccination and relevant booster(s). There is no evidence that getting vaccinated now will have adverse effects or toxicity that would preempt the administration of an additional vaccine dose in the fall months if there is evidence of waning of immunity, a new variant, or an adverse seasonal pattern.”
