Source: Washington Post
Read more: https://www.washingtonpost.com/health/2 ... ter-shots/New omicron-targeting coronavirus booster shots are poised for rollout after being authorized Wednesday by the Food and Drug Administration -- a move designed to improve protection against severe illness and death during a potential rise in covid-19 cases this fall and winter. The boosters, reformulated to take aim at the BA.4 and BA.5 omicron subvariants dominant in the United States, are scheduled to be reviewed by advisers to the Centers for Disease Control and Prevention on Thursday.
If the outside experts recommend the shots, and CDC Director Rochelle Walensky agrees, some boosters may be available starting this weekend, with more showing up in pharmacies, doctors offices and clinics after Labor Day. The emergency authorizations of the boosters -- one by Moderna and the other by Pfizer and its German partner, BioNTech -- mark the start of a high-stakes effort by the Biden administration to deploy a more muscular defense against a virus that has evolved drastically over the last 2 years and is still killing an average of 400 to 500 people a day in the United States.
The changes are the first since the mRNA vaccines debuted in December 2020. Scientists and physicians wonder whether the American public, which has been slow to embrace boosters, will show more enthusiasm for the newest crop of shots, which will be free to the public. Some experts, including Paul A. Offit, one of the FDA's most prominent vaccine advisers, have criticized the agency for moving too quickly, saying it is not clear the new booster is better than the current one and warning the agency's heavy reliance on mouse studies could fuel skepticism.
"We already have a problem with booster acceptance," Eric Topol, a professor of molecular medicine at Scripps Research, said. If that is exacerbated by the paucity of human data for the new shots, "I think that would be unfortunate." Peter Marks, top vaccine official at the FDA, defended the agency's approach, saying the mRNA vaccines have a strong safety record. And while cases are decreasing now, he said, some experts worry there could be a sharp rise in infections by Thanksgiving, as people flock indoors and immunity continues to wane. Waiting for additional data could cause a substantial delay in releasing the boosters, he said. "We have constantly been behind this virus, and we had to think creatively about how to safely catch up," Marks said in an interview before the authorizations. "If we are going to intervene, the time is ripe to do it now."