Questions About Omicron Remain as First Case Identified in US


With the first case of the Omicron variant identified in the U.S., questions remain about how dangerous the mutation is. And they’re unlikely to be answered for at least another week or two. 

First Omicron Cases IDed in the U.S.

The U.S. Centers for Disease Control and Prevention (CDC) reported that the Omicron variant of COVID-19 had been identified in California. The case was a resident of San Francisco who had traveled to South Africa recently. The patient was fully vaccinated and had mild symptoms. Health officials are conducting contact tracing to determine who the person was in contact with. To date, they have all tested negative. The CDC has said they are looking at potential other cases but did not say how many.

Some sources are suggesting that the Omicron variant, which appears to be more contagious than previous mutations, may have milder symptoms. The biggest concern at this time is the changes to the spike protein might allow it to evade immunity from vaccination and treatments with antibody therapies. People with natural immunity from COVID-19 infections would be expected to have immunity against Omicron.

However, Maria Van Kerkhove, the technical lead of the WHO’s coronavirus response, said officials in South Africa have reported Omicron cases with symptoms ranging from “mild disease all the way to severe disease.” So far, no deaths have been reported with Omicron. She also said that, so far, “there is no evidence to suggest that the vaccines don’t work” against Omicron.

An anecdotal case in Israel of a physician who tested positive with Omicron who accidentally exposed hundreds of people before he tested positive has resulted in only one positive test in the five days since. Most of the exposed people had received three shots of the Pfizer-BioNTech vaccine, although the incubation period is not yet over. The hope is that this indicates that people with booster shots will have protection against Omicron, although it’s still too early to know for certain.

However, in South Africa, Omicron is the most prevalent strain of the virus, replacing Delta. In November, approximately 75% of the 249 positive tests samples checked genetically in South Africa were Omicron. New cases are also rising after having dropped in recent months.

Moderna Says It Could Have Omicron Booster Ready by March

Stephen Hoge, president of Moderna, said yesterday that the company should have a booster shot targeting the Omicron variant tested and ready for U.S. Food and Drug Administration (FDA) authorization as early as March. Hoge said the second quarter would be more realistic. They have already begun the program to carry genes that target specific mutations in Omicron’s spike protein. It is also working on a multi-valent vaccine with four different coronavirus variants, including Omicron. It’s still unclear if a booster specific to Omicron will be necessary.

Moderna May Face Patent Infringement Lawsuit

The Federal Circuit U.S. Court of Appeals ruled that an administrative panel’s findings that Arbutus Biopharma’s patents on key technology for Moderna’s COVID-19 mRNA vaccine are valid. This opens up the possibility that Moderna will face a patent infringement lawsuit over the vaccine. Moderna previously stated in court filings that it thought Arbutus would sue for royalties from the vaccine if the patents were upheld. At the company’s most recent forecast, they projected 2021 vaccine sales of $15 billion to $18 billion, with $17 billion to $22 billion for next year. Currently, the vaccine is Moderna’s sole commercial product.

A New Kind of COVID-19 Vaccine in the Works

The COVID-19 pandemic has seen the rise of a number of new vaccine technologies, most prominently the mRNA vaccines by Moderna and Pfizer-BioNTech. Researchers at Novavax are about to roll out a new kind of COVID-19 vaccine called a protein subunit vaccine. In these types of vaccines, tiny pieces of the virus, specifically the spike protein in SARS-CoV-2, are injected into people. They are usually stable, so they do not require the extremely cold temperatures the mRNA vaccines demand. Novavax has shown a lot of promise but hasn’t quite lived up to it so far, constantly running behind their schedules for studies. The vaccine appears to work quite well but has had some manufacturing problems that delayed regulatory approval in the U.S. and other countries. They have partnered with several vaccine manufacturers, including the Serum Institute of India.

Germany Imposes Restrictions on the Unvaccinated

Outgoing Chancellor Angela Markel and Olaf Scholz, her successor, announced that Germany is banning unvaccinated people from all but the essential business, meaning grocery stores and pharmacies. They also restrict the number of people from large events, such as soccer matches. The German parliament is expected to vote on the issue before the end of the year, largely on the issue of mandatory vaccinations.

AstraZeneca Abandons Booster Plan

Recent announcements indicate that AstraZeneca is abandoning its plans to test the COVID-19 vaccine it developed with the University of Oxford for a third booster shot. It recently sent a letter to clinical trial participants, urging them to look for a third dose somewhere else. New York’s Montefiore Medical Center told trial participants earlier this week that after talks with the U.S. Food and Drug Administration (FDA), AstraZeneca was unlikely to test for a third dose. AstraZeneca-Oxford has yet to submit for clearance in the U.S. At this time, AstraZeneca has not made an official statement.

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