FDA officials: annual anti-Corona doses may be necessary in future
The United States may need to update covid-19 vaccines annually, according to three senior FDA officials, and the "new normal" may include an annual covid-19 vaccine, in parallel with the seasonal flu vaccine.
A paper by Dr. Peter Marks, director of the FDA Center for biology assessment and research, Dr. Janet Woodcock, principal deputy commissioner, and Dr. Robert Califf, the new FDA Commissioner, published in the medical journal "JAMA", reported Monday that "the spread of vaccine and infection - induced immunity, in parallel with the availability of effective treatments, may reduce the impact of future outbreaks. Nevertheless, it is time to accept the existence of ther H-2 virus, which causes covid-19, as the new normal. It is likely to spread globally in the foreseeable future, booking a place alongside other common respiratory viruses such as influenza. This may necessitate a similar annual study to update the vaccine's composition,"he said.
"In the process of developing a scheme and selecting the covid-19 vaccine for 2022-2023, it is important to recognize that the autumn season will provide a significant opportunity to improve covid-19 vaccination coverage, with the aim of reducing future community unrest and saving lives,"the doctors said.
"By developing an implementation plan for this year's vaccine selection mechanism, society is moving towards a new normal that may include annual covid-19 vaccination, similar to seasonal influenza vaccination,"they added.
June is likely to be the month during which FDA officials will make a decision on the composition of the "covid-19" vaccines for the fall and winter, and what the vaccination schemes are.
Officials at the agency, marks, Woodcock, Calif., said that by this summer, "decisions should be made" about who is eligible for additional covid-19 doses in the fall, and that vaccine formulations should be determined by June.
The food and Drug Administration announced last week that the Advisory Committee on vaccines and Related Biological Products will hold a meeting on June 28 to discuss whether the current "covid-19" vaccine formula should be modified and, if so, what updates should be chosen for the fall.
"With regard to practical considerations, the recent meeting of the Advisory Committee on vaccines and Related Biological Products concluded with a relatively uniform agreement that a single vaccine formulation would be favoured by all manufacturers, and that data would be needed to inform and guide the selection of a single, bivalent or trivalent covid-19 vaccine,"the researchers said.
"There was also general agreement that the recommendation of a new vaccine formulation should be based on the totality of available clinical and epidemiological evidence, and may be best used as a primary vaccine and as a booster dose,"the researchers added.
Members of the Advisory Committee on vaccines and Related Biological Products met in April to discuss how the combination of covid-19 vaccines could be changed to target any new and emerging variants of the coronavirus. The committee agreed that there was a need to develop a framework for how and when such adjustments would be made. The advisers plan to continue their discussion in the coming months.
FDA officials explained that " by the summer, decisions will be made for the 2022-2023 season on who is eligible to receive the vaccine with additional boosters, and the composition of the vaccine. Giving additional doses of covid-19 vaccine to eligible individuals this fall, within walking distance of the usual flu vaccine campaign, may protect vulnerable individuals from hospitalization and death, and the FDA should study this,"he said.
Some immunocompromised people aged 50 and over are eligible for additional booster doses of the"covid-19" vaccine in the United States. For those who have not yet been vaccinated or strengthened, getting a vaccine dose now will not have adverse effects that prevent getting an additional dose in the fall, agency officials said.
The current vaccine formulation could be updated to target circulating virus variants. The authors of the paper noted that in the coming autumn and winter, three factors may combine and put the country at additional risk of contracting the disease caused by "covid-19": weakened immunity, seasonal waves caused by the spread of the coronavirus, and the ongoing evolution of the coronavirus that leads to the emergence of new mutations.