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FDA may move towards vaccine renewal

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Washington — A panel of independent experts advising the Food and Drug Administration launched an existing Covid-19 vaccine on Tuesday to target a new version of the coronavirus with booster shots that Americans may get in the fall. We recommend whether to update.

The federal government wants to improve the vaccine to boost people’s immunity before the virus may relapse this winter. But to get it done quickly, a faster process that abandons the long human trials that have been used to test coronavirus vaccines over the past two years and relies more on laboratory and animal testing. May need to be upheld.

The latest test by human volunteers took 5 months, even with a relatively small group. However, due to the rapid evolution of the virus, new vaccine formulations are obsolete before such trials are completed.

Two major vaccine makers, Pfizer and Moderna, are both researching the latest vaccines targeting the predominant Omicron mutants last winter. Both companies have taken financial risk and have bet that the government will choose it as an autumn booster and have begun production of its updated version.

However, Omicron itself has been overtaken by a series of subvariants that began almost three months ago, and many scientists claim it is a threat that has passed.

“Omicron is clearly in the rear-view mirror,” said Dr. Peter J. Hotez, a vaccine expert at Baylor College of Medicine. Boosters targeting Omicron are meaningless unless they also work against the latest subvariants, he added, “I haven’t seen any evidence of that.”

At a meeting on Tuesday, the FDA will ask the advisory board if the modified vaccine should target a version of the Omicron family of viruses. It leaves it up to federal regulators to decide exactly which formulation to use in the fall.

Scientists initially had high hopes for the so-called bivalent vaccine, which combines an existing formulation with a formulation that targets Omicron itself. The results of a clinical trial released this month by Moderna and Pfizer with partner BioNTech have found that they induce higher levels of antibodies to Omicron than existing vaccines.

But while companies released their findings, outside scientists weren’t impressed with the less than double increase. Dr. Dan H. Baruch, a virologist at the Beth Israel Deaconess Medical Center in Boston, described it as “relatively modest.” And the FDA, With a new briefing document for the advisory boardBivalent Targeting Omicron said it was “already a bit outdated.”

Instead, federal regulators may require a bivalent vaccine that targets two subvariants of Omicron, BA.4 and BA.5. They currently account for more than one-third of infectious diseases in the United States and may resemble the incarnation of the virus that is prevalent in the fall.

However, the divalent targeting those subvariants is also problematic. Neither Pfizer nor Moderna are focused on development and no one knows how well it works. As of this later of the year, using human clinical trials for such vaccines, followed by the two months required to produce a dose, the release of the new vaccine was successful in the next wave of virus. It may be pushed in.

This suggests that authorities must make decisions primarily on the basis of animal and laboratory studies.

Dr. Kelly L. Moore, president of Immunize.org, a non-profit organization working to improve immunity, said such an accelerated process is already being used to renew the flu vaccine each year. rice field.

This is the first puncture wound in the country for the next-generation Covid vaccine, but she said existing vaccines are safely given to hundreds of millions of people. Updating them may require “very well-educated guesswork,” she said, but such deductions are “appropriate for the situation.”

If the government decides to do booster shots targeting BA.4 and BA.5, the competition to generate doses will continue by the fall, even with accelerated testing. According to two people familiar with Pfizer’s business, Pfizer may be able to meet the October deadline.

However, Moderna’s medical director, Dr. Paul Burton, said in an interview last week that the company is unlikely to be able to provide doses very late this year or until early next year. “We don’t think we’re ready to support the fall booster campaign,” he said.

It is possible that the virus will evolve again and the updated vaccine will be invalidated.

“Are you targeting BA.4 and 5? They will probably peak sometime next month or two months,” said Clinical Research Director, National Institute of Health, who conducted multiple coronavirus vaccine studies. Said Dr. John Begel. “It may be old news by the time autumn comes.”

Dr. Beigel said one option is to use the existing vaccine as is. Existing vaccines continue to provide strong protection against severe illness, but little protection against infection.

The Centers for Disease Control and Prevention, as of February, 60% of Americans are already infected with the virus It provides them with at least some temporary immunity. Breakthrough infections in vaccinated individuals are now common, but many cases are mild.

Still, the World Health Organization said this month that defenses against symptomatic treatments are rapidly deteriorating and that updated versions of the vaccine need to be studied.

Dr. Beigel and other public health officials say the virus is more agile than ever in avoiding antibodies that provide the first line of defense against infection.the study Existing booster shots show significantly lower levels of neutralizing antibodies to BA.4 and BA.5 than neutralizing antibodies to Omicron.

On average, 255 Americans still die daily from Covid and about 4,400 are hospitalized. According to the FDA’s briefing document, “a combination of weakened immunity, further evolution of mutants, and increased indoor activity” increases the risk of another large-scale Covid outbreak later this year.

The advisory board can be divided between those who believe that fall boosters are widely needed and those who limit additional shots to high-risk individuals. Dr. Arnold Monto, a professor of public health at the University of Michigan, who chairs the panel, predicted that booster shots would be provided over a large area of ​​the population.

“I know it’s declining,” he said in an interview. “We need to boost, and it’s better to boost with a more relevant vaccine than existing vaccines.”

At the other end of the spectrum is Dr. Paul Offit, a vaccine expert at the Philadelphia Children’s Hospital. “Hospitalization is declining. Deaths are much less because we are protected from serious illness,” he said. “That’s important.”

He may need a fall booster shot because only people over the age of 70 and people over the age of 50 with serious underlying illness can have serious consequences for Covid infections in these groups. Said to be high.

After all, how much spending is available to the government can determine the size of the new booster campaign. Congress has rejected the $ 22.5 billion White House request for emergency coronavirus funding, and a compromise to spend $ 10 billion has been stalled since April.government Shifted $ 5 billion in funding for coronavirus testing and protective equipment to buy new vaccines.

“We were able to use the resources we collected to collect vaccines for the fall, so it’s clear that not all adults who want a vaccine have enough vaccines,” said Dr. Ashish Jar of the White House. That’s it. ” The pandemic coordinator said in a briefing last week.

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