FDA panel meeting to discuss whether next-generation vaccines should target Omicron

Independent Advisory Board of the Food and Drug Administration Meeting on Tuesday Members are considering options for updating the coronavirus vaccine for booster campaigns aimed at preventing fall and winter spikes.

At the end of the all-day meeting, experts will vote on whether the vaccine should be represcribed to target Omicron or its submutants. Here you can watch the meeting live on YouTube..

Discussion questions According to the FDA’s circulation, the advisory group will also be asked if a vaccine that combines the original formulation with a vaccine that targets Omicron is preferable to a vaccine that targets only Omicron.Data supporting so-called “prototypes” or options that combine existing vaccines with Omicron have been extensively reviewed with regulatory agencies so far. Suggestions in briefing materials At the Tuesday meeting, such a design was “already somewhat outdated.”

Dr. Peter Markes, who oversees the FDA’s Vaccine Department, said at the beginning of Tuesday’s meeting that a good match between vaccines and mutants could lead to improved vaccine efficacy and durability.He said that a subvariant of Omicron known as BA.4 and BA.5 is currently composed. More than one-third of domestic casesIs “ready to become the dominant variant”, a hint on where regulators should look when choosing a new composition of coronavirus shots.

Dr. Marks displayed a timeline suggesting that an autumn booster campaign with newly designed shots could start in October, with manufacturers choosing vaccine designs to start dose production. He added that it would take about 3 months to do so.

Regulators will also ask advisors if healthcare providers should continue to use the original vaccine product this fall for those who have not yet been fully vaccinated if the booster shot composition changes. I am planning.

Members of the FDA committee may disagree on who should be vaccinated with the new vaccine. Some say there is a widespread need for fall boosters, while arguing that the next shot should be limited to high-risk individuals because the current vaccine protection against severe forms of Covid-19 is maintained. There are also people. start. Dr. Paul Offit, a vaccine expert and committee member at the Philadelphia Children’s Hospital, said that only people over the age of 70 and people over the age of 50 with serious underlying illness may need autumn booster shots. Is high.

The potential for more advanced vaccines has been teased for months by federal health officials who warned that as the virus evolves rapidly, its vaccine-induced protection against infection diminishes, enabling some Americans. Have come Reinfect Even in a few months.

In a briefing document released prior to Tuesday’s meeting, FDA officials said another large Covid later this year, “due to a combination of weakened immunity, further evolution of mutants, and increased indoor activity.” He said the risk of outbreaks would increase.

who Said this month Vaccine protection against symptomatic treatment is rapidly deteriorating and an updated version of the vaccine should be considered.

Two of the most widely used vaccine manufacturers in the United States, Moderna and Pfizer, are both researching Omicron-specific vaccines and hope to be seriously considered as a fall booster option. However, the research is complicated by subvariants, and neither company has yet developed a shot.

If the government decides that booster shots targeting BA.4 and BA.5 are needed, vaccine manufacturers will have to compete to produce doses by the fall. Pfizer may be able to meet the October deadline, but Moderna is likely not ready for the option until the end of this year or the beginning of next year, according to people familiar with the company’s business. ..

Tuesday’s debate could serve as a kind of referendum on the future of the pandemic in the United States and whether a rapidly changing virus could lead to a significant surge in hospitalization later this year. Justin T. Wrestler, an epidemiologist at the University of North Carolina at Chapel Hill, will present modeling to the Commission on Virus Trajectories.

Dead (number) It’s been less than 400 a day for the past few weeks Even when the number of cases of Omicron surged this spring, people died of Covid at a rate close to the lowest in a pandemic. Infectious disease experts attribute this trend to the protection that Americans have gained from vaccination and infection, and from new treatments such as: Oral antiviral drug Paxlovid..