Vaccine manufacturers pursue Omicron-targeted shots, which health authorities say may not be necessary

While Covid-19 vaccine manufacturers are preparing Omicron-specific shots, federal health officials say there are signs they may not be needed.

Research continues, however, and industry and global health officials say doses are targeted the highly transferable new variant may be necessary in the long run, especially if it ends up displacing past strains globally.

Different opinions on the need for Omicron-targeted shots highlight the persistent uncertainty about the relative effectiveness of current vaccines over the variant weeks after it began. sweeping across the United States

Researchers designed the existing Covid-19 shoots to fight the original coronavirus strain that dominated in 2020. Since then, the vaccines have remained effective against newer variants such as Delta, which have emerged and overtaken the original strain.

Cars lined up at a drive-through Covid-19 test site in Miami last month.


Photo:

Joe Raedle / Getty Images

The U.S. Omicron rise has sparked concern that vaccines may need to be adjusted to specifically target the strain because existing shoots do not appear to work as well against it, leading to several breakthrough infections.

Compared to the original coronavirus strain first identified in China, Omicron has a large number of mutations on the tip protein that may make it resistant to currently approved vaccines, scientists say. In an attempt to stay on the safe side, drug manufacturers including

Pfizer Inc.,

his partner

BioNTech SE

and

Modern Inc.

is preparation of modified shoots.

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U.S. health officials say there are practical reasons why Omicron-targeted shots may not be useful, and a good chance they would not be needed to counter the current Covid-19 increase.

“The reason for having an Omicron-specific vaccine is if you thought it would be the new normal – the new variant that will take over and continue to circulate over time,” said Peter Marks, Food and Drug Administration’s top vaccine. regulator, said. “Once we have an Omicron-specific vaccine manufactured, this wave will be over.”

Researchers also want to see how the immune responses generated by an Omicron-targeted shot are compared to those from original vaccines. For now, some experts in infectious diseases say, existing vaccines appear to be capable of protect against serious illness caused by Omicron as long as people get booster shots, although research continues.

A facility in Norwood, Mass., Run by Moderna, whose existing mRNA-based Covid-19 shot appears to protect against serious illness, though scientists say immunity may decline over time.


Photo:

Maddie Malhotra for The Wall Street Journal

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

Dr. Marks said the next two months should show whether Omicron is likely to dominate in the long run, outcompete other tribes like Delta, or fall back quickly like previous variants. For now, this uncertainty means there are risks and costs to pushing new vaccines prematurely, he and Drs. Mascola.

“We have strong evidence that current vaccines with a boost are working well.”


– Dr. John Mascola, Director of NIAID’s Vaccine Research Center

Pharmaceutical companies would have to start renewing their manufacturing processes and facilities to make new shoots, which would disrupt the production of existing vaccines necessary to immunize people globally, said Dr. Marks.

“You do not want to disturb anything unless you are pretty sure you actually need it,” he said.

However, industry leaders and global health officials have indicated that an Omicron-specific shot or additional boosters are likely to be needed in the end. While current mRNA-based vaccines like Pfizers and Modernas appear to protect against serious illness after a booster, protection may diminish over time.

After Merck’s Covid-19 vaccine candidates failed, the drugmaker partnered with rival Johnson & Johnson. WSJ reporter Jared Hopkins takes us behind the scenes as the first Merck-produced images are released for distribution. Photo: Hannah Yoon / WSJ

It said a technical advisory group from the World Health Organization on Tuesday current vaccines may need to be updated to provide adequate protection against infection and disease from variants such as Omicron.

Pfizer CEO Albert Bourla said “the most likely scenario” is for the company to switch to making an Omicron-targeted shot that is also effective against previous variants.

“I think we’re almost ready to go in [for authorization] and launch, if successful, and if we need it, in March, ”said Mr. Bourla at the JPMorgan Healthcare Conference on Monday.

An FDA spokeswoman declined to comment on Mr Bourla’s remarks.

Modern CEO Stéphane Bancel said at recent investor conferences that the current booster shot protection against Omicron may decline over time. He said he expects people will need another dose of Moderna’s vaccine in the fall, and it is possible that it will target Omicron alone or more than one strain. The drug maker said it plans to launch a clinical trial with its Omicron-specific booster early this year.

‘We are in this kind of Sisyphean game, where we always push the variant du jour forward until it is either necessary or not necessary.’


– Dr. Filip Dubovsky, Novovax’s chief physician

Novavax Inc.,

The manufacturer of a new vaccine not yet approved in the United States began manufacturing an experimental Omicron vaccine in December for test use, in case the company decides to start clinical trials in the first quarter, a spokeswoman said.

Novavax Chief Medical Officer Filip Dubovsky 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 emerged, though so far no one has been needed.

“We are in this kind of Sisyphean game, where we always push the variant du jour forward until it is either necessary or not necessary,” said Dr. Dubovsky.

Public health officials say they would like to know if any new Omicron vaccines are as effective as the current shots against other variants because strains like Delta continue to circulate and may rise again or develop into ever newer variants later.

It would take about three months for companies to complete the necessary studies to evaluate the strength of their vaccines against other variants and support an FDA approval, said Dr. Marks. He added that the risk that a new vaccine would not be as effective as the current one is an issue “that could keep me awake all night for a long time.”

In the longer term, the hunt for variants underscores the need for a next-generation vaccine that can fight various SARS coronaviruses and several variants, including known strains and those that come, some health experts say.

Still, some physicians with infectious diseases doubt that any “pan-coronavirus” vaccine will prove effective in the near future, citing researchers’ difficulties in developing pan-flu vaccines.

The U.S. military’s Walter Reed Army Institute of Research is develop an experimental Covid-19 vaccine which can potentially work against several variants. It started a small, early clinical trial with the shot last year, and the results await.

For biotechnology Inc.

and

GlaxoSmithKline

PLC is collaborating to develop a pan-coronavirus vaccine targeting several variants of the current coronavirus as well as future coronaviruses that may emerge.

The companies’ scientists aim to make a vaccine that not only works against all virus variants, but provides protection for up to several years compared to several months for current vaccines, said Vir Chief Scientific Officer Skip Virgin.

»If we could get three to five years [of protection], it would be a big step forward, ”he said.

Write to Joseph Walker at joseph.walker@wsj.com and Peter Loftus at peter.loftus@wsj.com

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