Following are some of the latest developments regarding COVID-19, the Omicron variant and the progress being made with new vaccines and treatment options.
Omicron Variant by the Numbers
In the last week we have seen more Omicron variant cases in more countries, but it remains uncertain how quickly it is spreading, or how severe it is compared to the more common Delta variant. As of 12/13/21, it has been reported in 69 countries and 30 U.S. states, with New York reporting the highest number of cases at 30. The numbers however, don’t tell the whole story right now. Current testing in labs across the country are accurately identifying the Omicron variant as COVID, but to actually identify Omicron on a molecular level, additional specialty testing must be done. Almost 20 million COVID tests are being done daily in the USA, but only 5 to 10% of these tests are being sequenced in a more sophisticated manner to specifically look for the Omicron variant. Also to be considered is the significant variation in testing on a geographic basis, as some counties and states are doing more individual testing than others; in other communities, testing of wastewater (sewage) for Omicron, Delta and other variants is being conducted.
The Role of Vaccines and Boosters
Pfizer reported that a booster dose of its COVID vaccine increases antibody levels by a factor of 25 over two doses. However, these results are based on laboratory research and studies done in small numbers of people. We will not know for 5 to 6 weeks just how effective the Pfizer vaccine is after the initial two-dose series versus two doses and a booster – and unfortunately will not be able to look at these numbers in a statistically significant way until Omicron is much more prevalent. Meanwhile, the company announced on 11/25/21 (Thanksgiving Day) that work had begun on a new vaccine specifically targeting the Omicron variant, with initial testing anticipated in January 2022 and availability as initial dose or booster expected by March 2022. Pfizer’s medical doctors and scientists have publicly stated they believe future booster doses will be needed.
Moderna and Johnson & Johnson. I suspect that Moderna and J&J will be releasing similar updates, data and opinions in the coming weeks. We have noted that both companies seem to be slightly slower than Pfizer in terms of getting information, paperwork and product out the door and submitted to the FDA and CDC.
New Treatment Options
Two new treatment options for COVID are “in the pipeline” from Merck and Pfizer. While they work in different ways, both are oral, antiviral medications that prevent the virus from reproducing itself. Both must be started within five days of the onset of symptoms, and appear easy to take with few side effects.
Merck: The US FDA Advisory Committee narrowly approved its drug, called molnupiravir, on 11/30/21. Those who voted against its approval cited safety concerns and modest efficacy. Notably, the FDA Commissioner has not yet formally approved molnupiravir and some interpret this as a sign that approval may not happen because of these concerns.
Pfizer: Meanwhile, Pfizer is pushing forward with a combination of two drugs that work together, and appears to be safer and more efficacious than molnupiravir. Indeed, it was so effective that the independent monitoring group stopped the double-blinded study early. None of the participants had been vaccinated, so we don’t know what the numbers will look like in the general population, but the initial numbers are dramatic:
- Just 3 of 389 people who took the drug within 3 days of the onset of symptoms were hospitalized, compared to 27 out of 385 in the placebo group.
- 6 out of 607 who started the drug within 5 days were hospitalized, compared to 41 out of 612 in the placebo group.
- No one who took the antiviral drug died, compared to 10 who took the placebo.
This drug is likely to be approved in the near future.
My perspective. I consider these drugs similar to Tamiflu, used to reduce the severity and duration of seasonal influenza: Patients who are sick receive 75 mg of Tamiflu twice daily for 5 days, while those who were exposed to flu receive 75 mg once daily for 10 days. The hope is that multiple safe and effective medications such as these will be developed to help defeat COVID. We know the coronavirus is capable of mutations, so having a number of therapeutic options available will be better than relying on a single drug. We will keep you updated on further developments regarding the new antiviral therapies.
How to Stay Safe
Get your booster: We continue to offer booster doses to all members of Larew Internal Medicine as well as their family members and friends. If you or someone you know still needs a COVID booster, please call our office and we’ll be glad to schedule a vaccine appointment promptly.
Encourage the unvaccinated to get their shot. Getting more people vaccinated is still the key to defeating COVID. As stated last week, I think the strongest arguments you can offer are personal and heartfelt: “Please get vaccinated because I love you” or “Please get vaccinated because I want to be with you, enjoying life, on the other side of this pandemic.”
I’ll continue to update you, and as always, I encourage patients to reach out with questions on their personal health situation.
Dr. Richard Larew