The FDA panel recommends changing Covid’s plans to deal with omicron this fall

The panel of independent food and drug administration vaccine experts voted Tuesday 19 and 2 this fall to recommend new Covid-19 shots aimed at the omicron variant when public health officials expect a new wave of infection.

This is the first time that panelists have proposed that vaccine authors change plans to target another variant. It is likely that the FDA will accept the commission’s recommendation and allow a vaccine change. However, the panel did not recommend which planes or omicron subvariant should be targeted.

Pfizer, Moderna, Novavax and Johnson & Johnson developed vaccines against the original Covid strain that originated in 2019 in Wuhan, China. But as the virus has evolved rapidly during the pandemic, vaccines have been effective. they protect against mild infections and diseases, although they generally continue to be protected from serious diseases.

A health worker prepares a syringe with the Modern COVID-19 vaccine at a vaccination site managed by SOMOS Community Care in Manhattan, New York, on January 29, 2021, during the COVID-19 pandemic.

Mike Segar | Reuters

Vaccines target the peak protein that the virus uses to invade human cells. However, the shots have trouble recognizing and attacking the point that is far removed from the original version of the virus. The Omikron variant is still the most dramatic example of more than 30 mutations. That’s one of the main reasons why omicron caused such a big wave of infection last winter, even though so many people are fully immersed.

Autumn promotion campaign

Omicron continues to mutate into more contagious subtypes. Dr. Peter Marks, who heads the FDA’s vaccines division, said the U.S. is facing Covid’s outbreak in the fall and winter as the virus evolves, as vaccine immunity declines, and people spend more time indoors, where Covid spreads much more easily than outdoors. which can.

“That’s why we need to consider a promotional campaign this fall to help protect us,” Marks told the committee. “The better we match the vaccine with circulatory tension, we believe it can improve the effectiveness of the vaccine and improve the durability of the vaccine.”

Justin Lessler, an epidemiologist at Chapel Hill University in North Carolina, said 95,000 more people could die by March 2023 as a result of Covid in the most optimistic projections of a group of scientists developing pandemic trajectory models. In the worst case scenario, 211,000 people could die from the virus by March next year, he said. However, Lessler noted that there is a great deal of uncertainty in these projections.

Three doses of the current vaccine are only 19% effective in preventing omicron infection after administration for 150 days or more among adults over the age of 18, according to data presented by the Centers for Disease Control and Prevention. This low protection against infection is likely due to the evolution of omicron into the infectious subariant BA.2 and BA.2.12.1, Dr. Ruth Link-Gelles, a CDC official, said. A third dose was 55% effective in preventing the hospitalization of these variants among adults within 120 days or more of receiving the shot, according to the data.

Limited data, limited time

The virus is evolving so fast that vaccine companies are struggling to keep going. Pfizer and Modern developed their omicron planes against the original version of the variant, BA.1. However, BA.1 is no longer circulating in the U.S. A more contagious subtype of Omicro, BA.2, dominated during the spring. Omicron sub-variants BA.4 and BA.5 are now gaining momentum in the US and are ready to dominate, Marks said.

Pfizer and Moderna presented data based on small studies of hundreds of people showing that their omicron shots significantly boosted the immune response against omicron BA.1 compared to the original shots aimed at the strain of the virus that originated in China. However, the updated shots did not perform as well as against BA.4 and BA.5, although the immune response was still strong. No data are available on the real-world effectiveness of the updated shots, although the strength of the immune response as a whole indicates how much protection the shots will provide against disease.

But Dr. Paul Offit, a member of the committee, said it is not clear whether the immune response data will be an important protection.

“I think we need a higher standard of protection than we are given – which I think is uncomfortably poor,” said Offit, an infectious disease expert at Children’s Hospital in Philadelphia, about the data presented at the meeting.

FDA panel members agreed that it would be best to target omicron BA.4 or BA.5. But this could pose logistical challenges for vaccine companies as they are geared towards BA.1. The manufacturing process of another sub-variant would take about three months.

Panel member Mark Sawyer said the FDA risks falling even further behind in the evolution of the virus if it does not act soon.

“Given this state of evolution, we’re going to be behind eight balls if we wait any longer,” said Sawyer, a professor of pediatrics at the University of San Diego in California.

Novavax presented data showing a strong dose of its current vaccine, targeted to the strain of the original virus, that produced a strong immune response against omicron subtypes. Dr. James Hildreth, a member of the interim committee, said he was most surprised by Novavax’s data and encouraged the FDA to allow a quick shot in the U.S. However, FDA official Jerry Weir said Novavax’s data has not been independently verified. agency.

Panel member Cody Meissner said she was concerned that there is insufficient safety data on how changing the composition of vaccines can cause heart inflammation or myocarditis as a side effect. Pfizer and Modern’s current shots have been linked to an increased risk of myocarditis in adolescent boys.

“We need more research or research to find out what the link is with vaccines and myocarditis,” Meissner said.

Marks said it’s crucial to decide whether vaccines need to be updated soon, so manufacturers have time to make plans for the fall. However, Congress has not put any money into the U.S. to buy additional vaccines. The White House has warned that without further funding, the U.S. will have to facilitate shooting in the fall for people at greatest risk, such as the elderly.

Dr. Ashish Jha, who coordinates Covid’s response in the U.S., said other countries have already entered into negotiations with vaccine officials for updated plans. The White House has funded $ 5 billion to start talks with companies while the administration waits for more money from Congress. The $ 5 billion that the White House is initially using for vaccines was originally intended for Covid testing and protective equipment, which means there is now less money for these key tools to deal with the pandemic.

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The FDA panel recommends changing Covid’s plans to deal with omicron this fall

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