COVID-19 Vaccine & Drug Makers Gear Up to Fight Omicron

The pharma, biotech and medical devices companies played a vital role in bringing the pandemic slightly under control by making vaccines, diagnostic tests and medicines/antibodies to treat COVID-19. The vaccines allowed global economies to recover, to some extent, after crashing in the first half of 2020 when the pandemic began.

Just when countries like the United States and Europe were seeing signs of the disease slowing down after third/fourth waves, the Omicron variant (B.1.1.529) has spread a sense of dread across much of the world.

The Omicron variant, which was first detected in South Africa and Botswana, has a large number of mutations. Some of these mutations are associated with a decrease in antibody protection and higher transmission, per the World Health Organization (WHO). The potential high risks of the Omicron variant led the WHO to add it to its “Variant of Concern” list on Nov 26. So far, around two dozen countries across the world have reported cases of the Omicron variant.

The fear of the variant is high due to concerns that it is potentially more contagious than the highly transmissible Delta variant and also due to its ability to bypass the protections provided by the currently available vaccines. The Omicron variant has ignited fears that the currently available COVID-19 vaccines and treatments could be less effective against it.

Per a Financial Times article published on Nov 30, Moderna’s MRNA chief executive officer (“CEO”) Stéphane Bancel warned that the heavily mutated Omicron variant may reduce the effectiveness of its authorized COVID-19 vaccine or booster dose. Moderna CEO stated that it will take several months before an Omicron-specific booster can be made available in large quantities to vaccinate a large number of citizens.

On the other hand, rival Pfizer PFE partner BioNTech BNTX believe their vaccine will likely offer strong protection against any severe disease from Omicron variant. Getting a third or “booster” shot of their vaccine should provide further protection against Omicron infection.

Omicron has once again shifted the focus on pharma/biotech companies in the hope that they make redesigned vaccines or drugs to combat this new mutation of the virus. Some vaccine makers including Moderna and J&J JNJ have announced their strategies for developing updated vaccines and boosters in order to respond to this variant. Companies like Regeneron REGN, making monoclonal antibody treatments for COVID-19, have also responded on how their medicines work against Omicron.

Moderna has already tested a 100-microgram booster dose, compared to its authorized booster dose of 50-microgram of its COVID-19 vaccine, mRNA-1273. The higher dose of its booster dose has resulted in the highest neutralizing titers against prior SARS-CoV-2 strains. Moderna is now rapidly testing sera from participants of high-dose booster studies to see if the dose provides neutralizing protection against Omicron.

Secondly, Moderna is also testing its two other existing multi-valent booster candidates against the Omicron variant. Thirdly, Moderna is also planning to develop an Omicron-specific booster candidate.

J&J is testing the effectiveness of its single-dose COVID-19 vaccine against the Omicron variant. The company is testing the blood serum from participants of completed and ongoing booster studies for neutralizing activity against the Omicron variant.

J&J is also pursuing a new vaccine against Omicron, which will be pushed to clinical development, rapidly, if needed.

Pfizer and BioNTech’s COVID-19 vaccine, Comirnaty is reportedly being tested to see if antibodies found in the blood of people vaccinated with their shot works against Omicron. Pfizer and BioNTech expect to be able to ship redesigned Comirnaty, if needed, to provide protection against the Omicron variant in approximately 100 days per a Reuters article.

Novavax, whose vaccine is not yet authorized in the United States, is also evaluating its vaccine against the Omicron variant. Novavax has also begun developing an Omicron-specific vaccine construct.

With regard to companies making monoclonal antibodies to treat COVID-19, Regeneron said that its antibody cocktail, REGEN-COV could be less effective against Omicron. Further tests are being conducted to understand the impact using the actual Omicron variant sequence.

Regeneron’s REGEN-COV comprises two monoclonal antibodies, casirivimab and imdevimab and has been effective against the Delta variant, which is the predominant strain in the United States at present.

Reportedly, Lilly is working to understand how its COVID-19 antibody cocktail, bamlanivimab plus etesevimab, works against Omicron. Gilead, reportedly, believes its drug Veklury (remdesivir) may continue to be effective against Omicron. Glaxo and partner Vir Biotech said that the pre-clinical data showed that their monoclonal antibody candidate, sotrovimab, retains activity against key mutations of the Omicron variant

Meanwhile, new oral antiviral pills, Paxlovid and molnupiravir, respectively from Pfizer and Merck, are expected to hold up well against the variant and help reduce the severity of infections, if authorized by the FDA. Both companies have filed applications with the FDA for emergency use approval for the pills.

The monoclonal antibody makers may be required to update their medicines in case Omicron becomes widespread.

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