The US FDA intends to simplify the COVID-19 vaccine process to make it look more like what happens in case of flu vaccine.This could include streamlining the composition of the vaccine, scheduling immunizations, and also providing periodic updates to the vaccines.
As per the FDA, it expects to evaluate the coronavirus circulating strains at least once annually and decide in June as to which strains to select for the fall. This is much like what happens in the case of annual flu vaccines.
As per the agency, going forward, most people may only need a single dose of the updated COVID-19 shot in order to restore protection, irrespective of how many jabs they have got before. There would be two doses needed for those who have never been exposed and are very young and those who have a weakened immunity and are elderly.
The agency is looking to shift towards only one vaccine composition rather than going ahead with monovalent vaccines, which are as of now used in the case of primary shots and aim at only one strain, and also bivalent vaccines used for boosters and aim at more than one strain.
According to the FDA, due to the simplification of the composition of the vaccine, the complexity can be reduced, thereby reducing the administration of vaccine errors because of the complex nature of the different vials that are present and thereby increasing vaccine compliance through transparent and robust communication.
The Vaccines and Related Biological Advisory Committee is set to meet on January 26 to discuss the future of COVID-19 vaccine schedules, and there is also a vote that might take place on whether the members agree on the parts of the FDA plan.
This has led to some mixed responses from vaccine experts. One of the former members of the FDA’s expert advisory panel states that the first and foremost thing to take into account is what is expected out of the annual vaccination.
It must be decided as to what the goal of the current vaccine is, and if that is to prevent serious disease or death, then that objective is already achieved. Before annual boosters are considered, the expert said that he would like to ascertain how the current, upgraded boosters fare against subvariants such as Omicron. The committee must also look to have a complete transparent approach from the FDA as well as the drug manufacturers during the decision making as per the expert. There were concerns raised in June last year as the FDA had not shared the entire data with the advisory committee which it possessed on bivalent boosters.
Dr. Peter Hotez, who happens to be the dean of the National School of Tropical Medicine at the Baylor College of Medicine suggests that he looks at the annual update plan as a balance between what is being rolled out and what science says is needed.
However, according to him, this plan has some flaws, as annual updates are just fine when it comes to the virus evolving incrementally based on the previous viruses that are circulating, but is there enough genomic surveillance to get hold of a radically different variant that pops out of nowhere just the way Omicron did. One does not have a surveillance mechanism to gauge it, and there isn’t any genomic sequencing in place either.
Director of the Institute of Immunology, University of Pennsylvania, Dr. John Wherry states the T-cells have been sticking around for up to nine months so far and they are indeed competent to protect against severe outcomes.
He has been studying how second-line immune defenders called T-cells are holding up against the coronavirus strains. Although there is no measurable decline in the T-cells, he is supportive of the FDA’s plans to have an annual COVID-19 jab.
