As the pandemic continues to evolve, Eden Health is here to keep HR teams and employers updated on the latest news and science.
This week, we’re addressing:
- Merck’s announcement about the success of its antiviral pill that reduces hospitalizations for COVID-19 by 50%
- How the flu and COVID-19 vaccines/boosters should be timed. Good news: They can be completed on the same day.
- Updates on the timeline for vaccines for children aged 5 to 11
- At-home testing shortages and the Ellume recall
- Where vaccine mandates stand. OSHA is expected to finish drafting the rule for employers in the next few weeks.
1. What do I need to know about Merck’s announcement regarding a pill for COVID-19?
The news from Merck about its antiviral pill, molnupiravir, was met with enthusiasm when it was announced on October 1. In a Phase 3 clinical study, molnupriavir halved the risk of hospitalizations in mild to moderate COVID-19 patients who are at high risk for COVID-19 infection. Besides the fact that it gives us another therapeutic in the fight against COVID-19, molnupiravir can be delivered in pill form versus intravenously like most monoclonal antibody treatments, our only other treatment for mild to moderate COVID-19. While the news is encouraging, further analysis of the trial and safety data is still needed. Merck is expected to submit their data on the trials soon for emergency use authorization (EUA) from the FDA.
There is also more in the pipeline for COVID-19 therapeutics. By the end of the year, we are likely to see results for other drugs, such as a similar pill from Atea Pharmaceuticals and Roche.
While the development of more therapeutics provides us with additional tools to fight COVID-19, there is no silver bullet, and the best course is to do your best to avoid infection. Vaccination, boosters, and non-pharmaceutical interventions which include wearing face masks in crowds and indoors, washing your hands with soap and water for 20 seconds, and maintaining physical distance, are still key to slowing and ending the pandemic.
2. It’s time for flu shots. Can COVID-19 vaccines and boosters be given at the same time as flu shots?
Flu season is about to start and while we don’t know how bad of a flu season we are going to have this year, it is likely we will see more flu this year than we did last. This is because more people are back in the office, traveling, and safety protocols like indoor masking and distancing have been relaxed in most places. The good news is that you can safely equip yourself and your employees against seasonal flu and COVID-19.
The time is now to make your appointment for a flu shot, as flu season typically starts in October/November and runs through March. The CDC strongly recommends all persons aged 6 months of age and older get an annual flu vaccination. Flu shots and COVID-19 vaccines/boosters can be given in a single visit. Side effects of getting both vaccines at the same time are similar to receiving the second dose of the vaccines or COVID-19 booster. If any of your employees have concerns or they aren’t feeling well the day of their flu shot or COVID-19 vaccine/booster appointment, they should contact their Eden Health provider to discuss the best course of action.
3. Is there an update on vaccines for children aged 5-11?
On October 7, Pfizer-BioNTech submitted their official request to the FDA for emergency use authorization (EUA) of its vaccine for children aged 5 to 11 years. Data from Pfizer-BionNTech’s trial among children showed that about one-third of the adult dose resulted in neutralizing antibody responses similar to those of adults.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) panel will meet on Tuesday, October 26 to discuss the data presented by Pfizer-BioNTech. If usual protocols are followed, a formal recommendation to the CDC Advisory Committee on Immunization Practices (ACIP) will be made shortly after the VRBAC meets. The CDC ACIP will then either accept, reject, or modify the recommendations put forth by the FDA advisory committee. Assuming things continue on the current timeline, a decision to extend a EUA to Pfizer for a COVID-19 vaccine for children should come no later than Thanksgiving.
4. I’ve heard there is a shortage of COVID-19 testing kits, especially at-home tests. What’s going on?
The demand for at-home COVID-19 test kits is at an all-time high and supply cannot keep up with demand. This is especially concerning given we are waiting for word from OSHA on specifics around the workplace vaccine mandate for employers with more than 100 employees. As described so far, the final language will likely include a requirement for regular testing for those employees who are not vaccinated. It has been reported that a final draft of the rule should be released in the coming weeks in time for the November deadline.
There are several reasons for the lack of supply. First, many of the government-provided mass testing sites have closed, pushing those who need a test to find alternatives such as over-the-counter tests. Second, only a few suppliers are approved by the FDA to make the at-home tests, limiting the bandwidth for production. Third, a major supplier of at-home tests, Ellume, is recalling a number of at-home COVID-19 rapid antigen test kits after an increased number of false-positive test results. The recall will affect the upcoming availability of home testing kits overall.
The FDA recently approved a new rapid antigen home testing kit that should help alleviate some of the supply-demand later this year. At this time, PCR testing remains widely available as a weekly testing option. To reduce the need for testing once the final OSHA rule is in place, we are here to support employers in their workforce vaccination efforts.
5. What is the latest on OSHA and vaccine mandates?
One month ago, the White House tasked OSHA with drafting an emergency temporary standard (ETS) requiring employers with more than 100 employees to either require employees to be fully vaccinated or to submit to regular testing. OSHA is still a few weeks away from releasing the final ETS.
The US Chamber of Commerce submitted a series of questions to OSHA which will help them draft the finer details of the vaccine and testing mandates. Some of the questions OSHA is considering as they draft the standard include:
- How employees will be counted (i.e. to include or not include permanent work from home employees, by location or in totality, etc.)
- Who will pay for testing
- What level of proof of vaccination will be required
- Does testing need to be proctored or done by a medical professional
We hope to have a final ETS by early November.
Eden Health is here to keep you up-to-date and answer your questions about the evolving pandemic. To learn more about our COVID-19 solutions, contact us today.
Authored by Heather Towery, M.D., VP Clinical Strategy and Enterprise Partnerships at Eden Health
Disclaimer: This information is based on current resources available and is subject to change. This document and its contents are provided for informational purposes only, and not intended to be, and should not be understood or treated as, a substitute for professional medical advice around COVID-19, its risks or symptoms, or to take the place of any local, state and national laws and guidelines around COVID-19. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition.