The national news cycle may have largely moved on from coverage of the COVID-19 pandemic — despite, as of this writing, infections being on the rise and more than 300 deaths tallied daily from the disease. But that certainly doesn’t diminish the unprec…
FDA says updated COVID-19 Omicron boosters won’t require new clinical trials
A Food and Drug Administration official said COVID-19 vaccine makers won’t need to carry out fresh clinical trials to receive approval for booster shots they’re updating for newer Omicron variants. Dr. Peter Marks, who runs the FDA’s Center for Biologics Evaluation and Research, told Reuters the agency will use data from trials for vaccines that target BA.1 — the Omicron variant that caused a huge surge in infections last winter — as well as manufacturing data to assess the vaccines. Safety data and preclinical data from animal studies may also be used.
This week, the FDA asked vaccine manufacturers to modify booster shots to target the Omicron BA.4 and BA.5 variants in addition to the original strain of the virus. The agency hopes the updated boosters will be ready by the fall. “It’s going to be really critical as we move into this fall where we’ve seen this evolution into BA.4/5, where we could see further evolution, to try to get as many people boosted as we can,” Marks said.
The Centers for Disease Control and Prevention says BA.1 isn’t circulating in the US anymore, but BA.4 and BA.5 now account for over 52 percent of COVID-19 infections in the country. Combined, they made up just 0.5 percent of cases in the US at the end of April.
Pfizer and Moderna this week released clinical trial data which suggests versions of their shots that target BA.1 offered a stronger immune response than the initial COVID-19 vaccines. Those boosters did not perform quite as well against BA.4 and BA.5. However, the data showed that the immune response was still robust.
FDA asks COVID-19 vaccine makers to update boosters to target new Omicron variants
The Food and Drug Administration has asked COVID-19 vaccine makers to update booster shots to tackle newer Omicron variants that are on the rise. It says the manufacturers should add a spike protein component to shots to target the Omicron BA.4 and BA.5 variants in addition to the original strain.
An “overwhelming majority” of the FDA’s advisory committee voted this week in favor of updating shots with an Omicron component, in the hopes of starting to use those modified boosters in the fall. The advisory is only for booster shots and not primary inoculations.
Vaccine makers are essentially playing whack-a-mole with the various strains of COVID-19. Pfizer and Moderna have created versions of their vaccines that target BA.1, the Omicron variant that caused a significant upswing in COVID-19 cases during the winter.
However, that strain isn’t circulating in the US anymore, according to the Centers for Disease Control and Prevention. Earlier this week, the CDC said BA.4 and BA.5 now account for over 52 percent of COVID-19 infections in the US. That figure is expected to rise in the coming weeks.
As CNBC notes, Pfizer and Moderna released clinical trial data this week showing that the current Omicron shots performed better against BA.1 than the original versions of their vaccines in terms of offering a stronger immune response. While the immune response against BA.4 and BA.5 was still said to be robust, the Omicron inoculations were less effective against those strains. It’s unclear how long it will take vaccine makers to develop shots that take aim at BA.4 and BA.5.
“Vaccine manufacturers have already reported data from clinical trials with modified vaccines containing an Omicron BA.1 component and we have advised them that they should submit these data to the FDA for our evaluation prior to any potential authorization of a modified vaccine containing an Omicron BA.4/5 component,” the FDA said. “Manufacturers will also be asked to begin clinical trials with modified vaccines containing an Omicron BA.4/5 component, as these data will be of use as the pandemic further evolves.”