Early Research on Omicron, Plus More COVID-19 News

The whole world is watching the news about the new COVID-19 variant, Omicron, but it’s becoming obvious that it will be a week or two before enough is known about how well current vaccines and therapies work against it. 

Is Omicron Less Severe Than Delta?

Presently, not enough is known about Omicron to make accurate predictions. Some evidence suggests that the symptoms are mild—and different—than what has been seen with Delta and other variants. However, some studies suggest it is more contagious. According to epidemiologists, that would not be the worst scenario. If it is more contagious but causes less severe disease, it would crowd out more dangerous strains, such as Delta.

Tony Blakely, Ph.D., professor of epidemiology at the University of Melbourne, said, “That may actually be a good thing because it means that as it washes through populations, you’ll have less morbidity and mortality. We don’t have a lot of evidence, but what we hear out of South Africa so far is that people are getting less sick. What we really want is a decent cohort study.”

Otherwise, some experts are criticizing the wealthier countries for the emergence of Omicron. The repeated statement has been that “no one is safe until everyone is safe,” and they have urged the wealthy nations to share vaccines globally. They argue that Omicron happened when the virus was allowed to spread broadly in countries where vaccines have not been readily available.

Andrea Taylor, assistant director of programs at the Duke Global Health Innovation Center, said, “Africa right now is essentially a superincubator” and Omicron “is exactly what experts have been warning about for months. We saw what happened with India, which gave rise to the Delta variant. And we said, ‘Look, this is going to happen in Africa where there is uncontrolled transmission.’”

Although the Omicron variant was first detected in South Africa, which has a 35% vaccination rate, that doesn’t mean it originated there. South Africa has a more rigorous variant screening program than most countries. However, Africa as a whole is only about 6% vaccinated. Experts think it’s likely Omicron developed somewhere on the continent.

Pfizer Plans to Produce 80 Million Doses of COVID-19 Antiviral Drug

Pfizer has reported plans of manufacturing 80 million treatment courses of its new antiviral drug against COVID-19, Paxlovid. The original production announcement was for 50 million. Company Chief Executive Officer Albert Bourla, Ph.D., told CNBC, “We can right now commit to 80 million doses … thanks to our manufacturing machine.”

The U.S. Food and Drug Administration (FDA) is reviewing the drug for an emergency use authorization (EUA). Bourla also said he believes the drug will be effective against the Omicron variant.

Pfizer and BioNTech also indicated they plan to ask the FDA to authorize their vaccine booster shot for 16- and 17-year-olds very soon.

South African Biotech Attempts to Replicate Moderna’s mRNA Vaccine

Afrigen Biologics and Vaccines, based in Cape Town, South Africa, is attempting to replicate Moderna’s mRNA COVID-19 vaccine. Like many parts of Africa and other parts of the world, there are difficulties getting supplies of COVID-19 vaccines. With 1.2 billion people, the African continent has only had 6% of its population vaccinated, largely due to short supplies.

Afrigen, with assistance from the World Health Organization (WHO), international consultants including representatives of the U.S. National Institutes of Health (NIH), is part of the continent’s first training and technology transfer hub for mRNA vaccines. Moderna, citing intellectual property, has not shared its formula for the vaccine, but Afrigen is using publicly available data and help from experts to make its version. Unfortunately, this will take up to three years to do. Petro Terblanche, managing director of Afrigen, has said if Moderna would share the information, it could produce a version within a year.

Moderna, however, announced in October that it was spending up to $500 million to build its own vaccine factory in the continent, potentially in Senegal, Rwanda, or South Africa, to produce up to 500 million doses of the vaccine annually.

FDA Adcom Meets Today to Discuss Merck and Ridgeback’s Molnupiravir

The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) meets today to discuss Merck and Ridgeback Biotherapeutics antiviral drug, molnupiravir. On October 1, the two companies reported interim data on the Phase III trial in mild-to-moderate COVID-19. The data was strong, decreasing the risk for hospitalization and death in adults by about 50%. However, when the data was fully released, the final analysis had the drug at about 30% effectiveness. Two other concerns are expected to be discussed: whether the drug is safe for pregnant women, and if it could cause vaccine-resistant COVID-19 mutations, which does happen with antiviral drugs. However, Merck’s research to date hasn’t indicated that occurs with molnupiravir.

Moderna Chief Says Vaccines Less Likely to Be Effective Against Omicron

Although it may be a week or two until they know for sure, Moderna’s chief executive officer Stéphane Bancel said he does not believe current vaccines—including Moderna’s—will be as effective against the Omicron variant as they were against other strains, including Delta. The mRNA vaccines, such as Moderna and Pfizer-BioNTech, target the virus’s spike protein. The Omicron variant has mutations in up to half of its spike protein.

Bancel suggested this might require companies to modify their vaccine, which could take up to 100 days to accomplish. Pfizer-BioNTech has said they are already testing their vaccines and deciding how to modify them. China company Sinovac said it is also collecting samples of Omicron to determine if its inactivated vaccine, CoronaVac, works against the variant. Some of the COVID-19 vaccines worldwide target the entire virus or the spike protein and other components. Although that would require testing, theoretically, those types of vaccines would be as effective against Omicron as against other strains.

Pfizer is hopeful that booster shots will offer enough protection against Omicron, although it is testing and making plans to develop a new vaccine if necessary. Pfizer believes they will know enough about Omicron by the end of the month.

“We do take the new variant of concern, Omicron, with seriousness,” Mikael Dolsten, M.D., Ph.D., Pfizer’s chief scientific officer, told STAT. “It can indeed be a potential new threatening wave … although we don’t know that yet. But we always start with being prepared for the worst.”