December 8, 2021
Last week the CDC confirmed the first U.S. case of the newly identified variant of concern, Omicron (B1.1.529). Presently little is known about the Omicron variant. The CDC recently released a Health Alert Network (HAN) health advisory emphasizing how important it is for the public health, medical communities, and the general public to remain vigilant to reduce potential exposure. The health advisory provides current knowledge on Omicron and includes guidance on how to best detect this variant within the U.S. to help mitigate its spread. Vaccination remains the best protection against COVID-19, including the Delta variant.
It remains Ventegra’s deep commitment to our clients to provide the most updated and relevant one-stop-shop resource on COVID-19.
Key highlights for this update:
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The Delta variant continues to account for more than 99% of the sequenced COVID-19 cases in the U.S.
- Omicron variant and what you need to know
- Viral mutations and the role of vaccinations
- FDA advisory panel vote to recommend EUA for Merck’s oral antiviral, molnupiravir
- MedPage Today Track the Vax podcast: Does a Past COVID Infection Protect Just as Well as Vaccines by Bob Wachter, M.D.
COVID-19 VARIANTS
The CDC genomic surveillance program continues to identify new and emerging SARS CoV2 variants and provides an estimated bi-weekly proportion of the most common variants circulating in the U.S. Currently, the highly transmissible Delta (B.1.617.2) variant accounts for almost 100% of the sequenced COVID-19 cases in the U.S.
Omicron (B1.1.529) Variant
The Omicron (OH-muh-kraan or OH-my-kraan) variant was first identified in South Africa in late November and is now classified as a variant of concern by the World Health Organization. Early analysis of the Omicron variants shows a higher number of mutations, but the significance of these changes is still unknown and continues to be studied.
The three main areas of concern for new variants like Omicron are:
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Transmissibility: still unknown, some changes (mutations) seen with Omicron could increase its ability to spread to others, but it is still unclear how this compares to the Delta variant
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Disease severity: still unknown, but preliminary data from South Africa shows no unusual symptoms
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Ability to evade current vaccinations and treatments: still unknown
On November 29th, 2021, the CDC strengthened its previous recommendations for booster doses for individuals 18 years and older, in part due to the emergence of the Omicron variant. The CDC is closely monitoring the Omicron variant activity, and despite many of the unknowns, vaccination remains the best public health measure to slow the transmission of COVID-19. Masking, testing, and use of all the tools available to protect yourself and others are recommended until we know more about Omicron.
Expect to see more data and information on the Omicron in the coming weeks.
Why viruses mutate and the role of vaccinations
Viruses cannot survive on their own; they require the support of a host to replicate. Once infected, the host’s cells are leveraged to make more virus copies. Sometimes during that process of viral replication, errors (mutations) occur that can change the viruses’ characteristics.
Not all mutations are clinically significant, but some can be (see above on Omicron and main concerns). Viruses with one or more mutations are called variants. Through an evolutionary process (survival of the fittest), mutations that make the virus more infectious and robust can lead to new, dominant variants.
Individuals with weakened immune systems, or those without an adequate level of protection for a given virus, cannot as easily defend against that virus’ replication cycle. A higher number of replications inevitably increases the risk of new variants.
The risk of COVID-19 infection cannot be eliminated entirely with vaccination, but one of the main targets of the current vaccines is to decrease viral replication by preventing entry into the host’s cells. Therefore vaccines are an essential defensive tool for reducing viral replication and the emergence of future variants. Improving vaccine uptake in the U.S. as well as increasing global vaccination rates are important steps toward overcoming the global pandemic.
Approximately 71% of the U.S. population has received at least one dose of a COVID-19 vaccine, worldwide 55%, but in low-income countries, only 6.2%. That means over 3 billion remain unvaccinated. We live in a global economy, and SARS-CoV-2 is an equal opportunity pathogen, so we must address this challenge holistically. The Omicron variant is an example of things we will see in the future if we cannot overcome the global pandemic. To hear more on this topic – listen to the Ventegra webinar from August 31, 2021, discussing COVID variants with Dr. Steven Park.
FDA Advisory Panel votes to recommend EUA for Merck’s oral antiviral, molnupiravir
On November 30, 2021, the Antimicrobial Drugs Advisory Committee voted 13 to 10 in favor of molnupiravir, a novel oral antiviral medicine for the treatment of mild to moderate COVID-19 in adults. Keys areas of discussion included the relative risk reduction of hospitalizations and death and the risk/benefits in various patient scenarios (pregnancy, access to monoclonal antibodies).
The EUA approval is now in the hands of the FDA for their decision. The FDA is not bound by the advisory committee’s recommendations but generally considers the committee’s advice.
MedPage Today - Track the Vax podcast: Does a Past COVID Infection Protect Just as Well as Vaccines by Bob Wachter, M.D. – December 1, 2021 release
In Ventegra’s November 17, 2021 E-blast, we highlighted natural immunity, vaccinated immunity, and correlates of protection. A Track the Vax podcast with Bob Wachter, M.D. Professor and Chair of Medicine at the University of California, San Francisco, provides thoughtful insight on this topic in a 21-minute podcast.
