Vaccine Makers Pursue Omicron-Targeted Shots That Health Officials Say Might Not Be Needed

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Industry officials expected final demand for analog supplements, but US officials say existing evidence does not support rolling them out and cite practical reasons.

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The differing opinions on the need for Omron-targeted shots highlight the persistent uncertainty around the relative efficacy of existing vaccines against differing weeks after their widespread introduction in the US.

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Researchers have designed existing COVID-19 shots to fight the original coronavirus strain that prevailed in 2020. Since then, the vaccines have been effective against new variants such as Delta that have emerged and have overtaken the initial strain.

The US omicron boom has led to concerns that vaccines may need to be tweaked to specifically target the strain because existing shots don’t work as well against it, which could lead to more successful infections.

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Compared to the original coronavirus strain first identified in China, Omicron has a larger number of mutations on the spike protein that could make it resistant to currently authorized vaccines, scientists say. In an effort to be on the safe side, drugmakers including Pfizer Inc.,

Its partners BioNTech SE and Moderna Inc.

Preparing modified shots.

US health officials say there are practical reasons why omicron-targeted shots may not be useful and there’s a good chance they won’t be needed to address the current COVID-19 surge.

Food and Drug Administration’s top vaccinator Peter Marks said, “The reason for having an oomicron-specific vaccine is if you think it’s going to be the new normal—the new version that’s going to move over time and keep circulating. ” The regulator said. “By the time we manufacture an omicron-specific vaccine, this wave will be over.”

The researchers also want to see how the immune response generated by the Omicron-targeted shot compares to the original vaccines. For now, some infectious-disease experts say, existing vaccines appear to be able to protect against serious disease caused by Omicron until people get booster shots, though research is ongoing.

“We have strong evidence that existing vaccines work well,” said John Mascola, director of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases. He and other scientists there have collaborated with Moderna to evaluate its vaccine against Omicron.

Dr. Marks said the next two months should show whether Omicron is likely to prevail over the long term, beating other strains such as Delta, or retreating as rapidly as previous variants. For now, that uncertainty means there are risks and costs to pushing new vaccines prematurely, he and Dr. Muskola said.

Dr. Marx said pharmaceutical companies will have to start improving their manufacturing processes and facilities to create the new shots, which will disrupt the production of existing vaccines needed to immunize people globally.

“You don’t want to interrupt something unless you’re absolutely sure you really need it,” he said.

However, industry officials and global-health officials have indicated that an omicron-specific shot or additional boosters will probably be needed eventually. While current mRNA-based vaccines such as Pfizer and Moderna seem to protect against serious disease after a booster, protection may diminish over time.

The Technical Advisory Group of the World Health Organization said on Tuesday that Current vaccines may need to be updated To provide adequate protection against infection and disease from types such as Omicron.

Pfizer Chief Executive Officer Albert Boerla said the “most likely scenario” is for the company to switch to making an Omicron-targeted shot that is also effective against earlier versions.

“I think we’ll be almost ready to file [for authorization] And launch, if it’s successful and if we need it, in March,” Mr. Baurla said at the JPMorgan Healthcare conference on Monday.

An FDA spokeswoman declined to comment about Mr. Borla’s remarks.

Moderna CEO Stefan Bansel said at recent investor conferences that the current booster shot’s protection against Omicron could degrade over time. He said he expects people to need another dose of Moderna’s vaccine in the fall, and it’s possible that it will target Omicron alone or more than one strain. The drugmaker said it plans to begin clinical trials of its Omicron-specific booster earlier this year.

novavax Inc.,

The maker of a new vaccine, not yet authorized in the US, began manufacturing an experimental Omicron vaccine in December for trial use, if the company decides to begin clinical trials in the first quarter. So said a spokesperson.

Novavax’s chief medical officer Philip Dubowski said the company can prepare new variant-specific versions of its COVID-19 vaccine relatively easily and has done so in the past when new strains have emerged, although none are needed yet.

“We are in this sort of Sisyphean game always pushing the variant du jour until it is either needed or not,” Dr. Dubowski said.

Government health officials say they would like to know if any of the new Omicron vaccines are as effective as existing shots over other variants, as strains such as Delta continue to circulate and may later recur or evolve into new variants. can.

Dr. Marks said it would take about three months for the companies to evaluate the potential of their vaccines against other variants and to complete the necessary studies to support FDA authorization. He added that the risk that a new vaccine will not be as effective as currently in question is “one that could keep me up all night longer.”

Some health experts say that in the long run, the pursuit of variants underscores the need for a next-generation vaccine that can combat the various SARS coronaviruses and multiple variants, including known strains and those to come.

Still, some infectious-disease doctors are skeptical that any “pan-coronavirus” vaccine will be shown to be effective in the near future, citing researchers’ difficulties in developing pan-flu vaccines.

The US Army’s Walter Reed Army Institute of Research is developing an experimental COVID-19 vaccine that could potentially work against multiple variants. It began a small, early-stage clinical trial of the shot last year, and the results are pending.

for biotechnology Inc.

and GlaxoSmithKline plc are collaborating to develop a pan-coronavirus vaccine that can target multiple forms of the current coronavirus, as well as future coronaviruses that may emerge.

Weir’s chief scientific officer, Skip Virgin, said the company’s scientists aim to create a vaccine that will not only work against all virus types but will provide protection for many years, compared to several months for existing vaccines.

“If we can get three to five years” [of protection]This will be a big step,” he said.

Write Joseph Walker at [email protected] and Peter Loftus at [email protected]

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