How Covid Vaccine Makers Are Preparing Their Omicron Response

There has long been an expectation that a potentially dangerous variant would emerge so vaccine makers anticipated that by testing vaccines that could handle multiple strains. 

Those new vaccines await testing to determine if a new vaccine is even necessary and if so, which of their off-the-shelf alternatives will work best. Despite the global panic, the Omicron variant is very similar to the original virus and has not yet caused a rise in hospitalizations or deaths. JL

Gregory Zuckerman reports in the Wall Street Journal:

Vaccine makers will spend several weeks assessing the danger of the Omicron variant. Immunologists (are) determining whether antibodies generated by current vaccines protect against the Omicron variant or if new vaccines will be needed. Companies are awaiting lab tests to see. The variant has so far produced few severe cases of Covid-19. Existing vaccines may prove capable of protecting against hospitalization and death by Omicron, even if they prove less effective at preventing infections. Vaccine companies, anticipating potentially dangerous variants, already tested vaccines (to) tackle multiple strains of the virus, which have been on the companies’ shelves in case a need for them arose

Vaccine makers will spend several weeks assessing the danger and potential impact of the coronavirus’s new Omicron variant.

But they are already racing to develop ways to combat it.

“We’re on it,” said Dan Barouch, an immunologist at Beth Israel Deaconess Medical Center in Boston who helped develop Johnson & Johnson’s Covid-19 vaccine. Now, he is working to determine whether immune-system agents known as antibodies and T cells generated by current vaccines protect against the Omicron variant or if new vaccines will be needed.

On Thursday, South African scientists issued a warning about the variant, which has a high number of mutations. On Friday, the World Health Organization arranged a meeting of experts to declare the new strain a “variant of concern.”

By then, vaccine makers had already begun work to protect against the variant, which has been named Omicron.

At Moderna Inc.’s offices in Cambridge, Mass., alarm bells went off last Tuesday. The company’s team that tracks variants noticed unusual activity in a global database run by the nonprofit Global Initiative on Sharing All Influenza Data, or GISAID, as scientists around the world began uploading information about a new strain, says Moderna President Stephen Hoge.

The Moderna team saw roughly 50 mutations on the new variant, which could potentially render it more transmissible and allow it to evade immune responses generated by vaccination and previous infection.

“Everyone’s blood pressure went through the roof,” says Dr. Hoge. “It was all the mutations we didn’t want to see together in one variant.”

On Thursday morning, the Thanksgiving Day holiday in the U.S., government scientists including Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and John Mascola, director of the institute’s vaccine research center, spoke with leading vaccine makers to discuss how to respond, according to a person familiar with the discussions.

The Biden administration and leading academics also were in touch with the major vaccine companies to debate strategy.

For now, it is too early to determine a course of action, researchers at the vaccine companies say. Over the next few weeks, they will watch to see if infections from the new variant lead to a surge in hospitalizations and deaths, a sign that Omicron is more dangerous than previous coronavirus variants.

Until now, Omicron has mostly been detected in Southern Africa, where populations are younger and healthier than in some Western countries. Researchers want to see how older populations with other medical conditions in Europe and elsewhere are affected by the variant.

Vaccine companies are also awaiting data from lab tests under way to see if existing vaccines generate sufficient neutralizing antibodies to combat the new variant. If antibody levels remain high, it could suggest the shots will continue to provide ample protection.

Data from the testing and from the real-world impact of the variant on populations in the West will likely arrive around the same time, by the middle of December, the researchers say.

The good news, according to scientists at the vaccine makers: The variant has so far produced few severe cases of Covid-19. Existing vaccines may prove capable of protecting against the worst outcomes, including hospitalization and death caused by Omicron, even if they prove less effective at preventing infections.

While the new variant has dozens of potentially important mutations, the virus’s spike protein still largely resembles that of the original strain of the coronavirus, sharing 95% of the same amino acids. As a result, the body’s immune system may be able to identify the virus and mobilize an effective response to Omicron, just as the shots proved largely effective at fighting previous variants.

If existing vaccines provide sufficient protection, it could signal they can handle even the most worrisome variants, signaling a potential turning point in the fight against the coronavirus.

If high numbers of cases of severe disease emerge or antibody data from the vaccines proves disappointing, however, the vaccine makers have several options. Some could distribute updated, higher-dose booster vaccines potentially capable of fighting Omicron. Moderna has already conducted clinical trials of a high-dose Covid-19 vaccine and has existing safety data, so the company likely wouldn’t have to conduct a time-consuming trial of the new vaccine, the company says.

At the same time, some vaccine companies, anticipating potentially dangerous variants, have already tested multivalent vaccines, or those that can potentially tackle multiple strains of the virus. These souped-up vaccines, which have been on the companies’ shelves in case a need for them arose, also may be able to handle Omicron, though these shots would still need to be manufactured, which could take months.

If these existing vaccine approaches prove unable to sufficiently protect against Omicron, companies whose Covid-19 vaccines are based on the genetic sequence of the virus—including Pfizer Inc. and partner BioNTech SE, BNTX +2.86% Moderna, J&J and AstraZeneca PLC—could return to their labs and rework their shots to include the sequences of the new variant to produce protective shots.

It likely would take Moderna and Pfizer-BioNTech, which developed Covid-19 vaccines using messenger RNA molecules, about two months to develop new vaccines to specifically combat Omicron, scientists said.

Last week, Moderna began work on such a new vaccine, in case it is needed. A spokeswoman for Pfizer said the company and BioNTech have long prepared to adapt their vaccine within six weeks and ship initial batches in 100 days in the event of a new, dangerous variant.

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New vaccines specifically aimed at combating Omicron would still need to be tested in clinical trials. That would take a period of time that would depend on the data demanded by regulators, said Prof. John Bell, a senior University of Oxford academic who negotiated the university’s vaccine alliance with AstraZeneca last year.

Clinical trials could take several months. But a new Moderna vaccine aimed at protecting against Omicron could be ready to go into arms in the late winter or early spring, Dr. Hoge says. J&J and AstraZeneca PLC, which produce Covid-19 vaccines using adenoviruses, rather than mRNA, likely could update their vaccines in a somewhat longer period, researchers said.

AstraZeneca, which developed its vaccine with the University of Oxford, said it is conducting research in Botswana and Eswatini, locations where the Omicron variant has been identified to obtain real-world data about how the vaccine performs against the latest mutated virus.

“We are closely monitoring newly emerging Covid-19 virus strains with variations in the SARS-CoV-2 spike protein and are already testing the effectiveness of our vaccine against the new and rapidly spreading” variant, a J&J spokesman said.

On Friday, Moderna shares climbed nearly 21%; BioNTech rose 14%, and Pfizer climbed 6%, a sign that investors believe new demand will emerge for the vaccines and they will be effective against Omicron.