WHO, US, EU, Pharma Provide Updates on Omicron Variant

The World Health Organization (WHO), the US Food and Drug Administration (FDA), the European Commission (EC), Pfizer, Moderna, and Johnson & Johnson (J&J) have provided updates regarding the COVID-19 B.1.1.529 variant (Omicron).

Updates from global regulators

Late last month (November 26, 2021), the World Health Organization (WHO) designated the Omicron coronavirus variant, first identified in South Africa, as a variant of concern on the advice of WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). Researchers in South Africa and globally are conducting studies to better understand the variant.

WHO says it is not yet clear whether infection with Omicron causes more severe disease compared to infections with other variants, including the Delta variant Preliminary data suggests that there are increasing rates of hospitalization in South Africa, but this may be due to increasing overall numbers of people becoming infected, rather than a result of specific infection with the Omicron report.

Meanwhile, thus far (as reported on December 2, 2021), cases of the Omicron variant have surfaced elsewhere, including in the US, the Europe Union, and elsewhere globally. In a November 30, 2021 statement from Janet Woodcock, M.D., Acting Commissioner of Food and Drugs, the FDA says it is actively working with federal partners, international regulators, and medical product companies to quickly address any potential impacts of the new Omicron variant.

 “The FDA anticipates having more information from the ongoing evaluation regarding if and how well the current vaccines work against this variant in the next few weeks.” Dr. Woodcock said in the November 30, 2021 statement, “If a modification to the current vaccines is needed, the FDA and companies will work together to develop and test such a modification quickly.”

The EC also issued a statement to reiterate calls to step up vaccination, deployment of boosters, and reaction to Omicron variant. The EC says the EU and its member states must demonstrate the capacity to address the upsurge in the virus and to maintain the drive for a long-term response. As one measure, the EC says member states should rapidly deploy booster doses to maintain strong levels of protection against the virus, including the Omicron variant, starting with the most vulnerable patient groups. The EC also says it will step up efforts to produce, authorize, and jointly procure COVID-19 therapeutics. A full outline of the suggested urgent responses can be found here.

Updates from pharma companies

At the same time, vaccine manufacturers have announced plans to address the Omicron variant. Pfizer says it has established an approach to develop and produce variant versions of its COVID-19 vaccine in ~100 days (as reported on December 2, 2021), if needed, subject to regulatory approval. The company says it has already started working on a DNA template to match the Omicron variant to provide protection against the COVID-19 variant if its current vaccine does not provide enough protection. Pfizer has already produced 3 billion doses of its COVID-19 vaccine in 2021 and says if it needs to update the vaccine for Omicron, subject to authorization, the company will be ready to produce the same number of doses of the new vaccine.

Moderna says it will pursue a strategy involving three levels of response should its currently authorized 50-µg booster dose of its COVID-19 vaccine prove insufficient to boost waning immunity against the Omicron variant. The three levels of response include: (1) testing a higher dose booster (100 µg) of its vaccine  in healthy adults; (2) evaluating two multi-valent booster candidates being evaluated against variants, such as the Omicron variant; and (3) advancing an Omicron-specific booster candidate (mRNA-1273.529).

J&J says it has been closely monitoring newly emerging COVID-19 variants. In collaboration with academic groups in South Africa and globally, the company has been evaluating the effectiveness of its COVID-19 vaccine across variants, including now the new Omicron variant. J&J is testing blood serum from participants in completed and ongoing booster studies to look for neutralizing activity against the Omicron variant. In addition, the company says it is pursuing an Omicron-specific variant vaccine and will progress it as needed.

Additionally, Inovio, a Plymouth Meeting, Pennsylvania-based biopharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, is moving to evaluate its COVID-19 DNA vaccine candidates, INO-4800 and INO-4802, against the emerging Omicron variant. Concurrently, Inovio has initiated pre-clinical development of an Omicron-specific DNA vaccine candidate and will progress if needed.

Source: World Health Organization, US Food and Drug Administration, European Commission, Pfizer, Moderna, Johnson & Johnson, and Inovio