COVID-19 related hospitalizations and deaths continue to decline in the U.S., however the 7-day moving average of new cases plateaued briefly and now is showing an uptick. Several areas are still in the high-community transmission zone. Vaccination remains to be 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:
- The more transmissible Delta variant continues to account more than 99% of the sequenced COVID-19 cases in the U.S.
- Pfizer/BioNTech COVID-19 vaccine is now available for children ages 5 through 11
- Natural immunity, vaccinated immunity, and correlates of protection
- Pfizer/BioNTech request FDA expansion of EUA for COVID-19 vaccine booster doses
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 more transmissible Delta (B.1.617.2) variant accounts for over 99% of the sequenced COVID-19 cases in the U.S.
Pfizer/BioNTech COVID-19 vaccine for children ages 5 through 11 years of age
The FDA authorized the Pfizer/BioNTech COVID-19 vaccine for children ages 5 through 11 years under emergency use followed by the CDC recommending its use in this age group. The vaccine was found to be 90.7% effective in preventing COVID-19, with no serious side effects being detected in the ongoing trial within this age group.
The pediatric formulation (5 to 11 years) is different than the current (for 12 years and older) with a primary series dose of 10 mcg (1/3 the current dose) but with the same 2-dose schedule, 21 days apart. In addition to the lower dosage, the pediatric formulation can be stored in a refrigerator [2ºC to 8ºC (35ºF to 46ºF)], for up to 10 weeks – because of this, there will be greater access through physician offices and pharmacies.
The American Academy of Pediatrics (AAP) and the American Academy of Family Practice (AAFP) also endorsed these recommendations.
Natural Immunity, vaccinated immunity, and correlates of protection
Natural immunity is individuals previously infected with COVID-19 and recovered and therefore have a level of protection from being reinfected. Vaccinated immunity, as it implies, means those who have received a COVID vaccine and have a level of protection from being infected. Correlates of protection (or immunity) are a surrogate measurement for predicting the level of protection one has against being infected or reinfected. Below are some commonly asked questions in this area. It is important to note that the data and science in this area continue to evolve and is subject to change.
So why are these terms important, and how are they interrelated?
Individuals who have been infected or vaccinated would like to know if they have protection against SARS-CoV-2 – hence, the importance of identifying a correlate of protection. In addition, there are active discussions on the level of protection for those previously infected and the value of vaccinating these individuals.
Is there a correlate of protection (immunity) for those naturally infected or fully vaccinated?
No – unfortunately, there is no FDA-authorized test that indicates if a person is protected or not. On-going studies are examining this and, depending on the type of immunity evaluated (natural vs vaccinated), will drive what is measured. Studies have shown that antibody titers correlate at a population level but are unknown at an individual level.
Does being previously infected with SARS-CoV-2 provide a level of protection against COVID-19?
Yes – per the CDC, the available evidence shows that individuals previously infected with SARS-CoV-2 and fully vaccinated with their primary series have a low risk of infection for at least six months.
Should I get vaccinated if I have already had COVID and if so, why?
The CDC is recommending that previously COVID infected individuals still be vaccinated. This is because the length of protection is still unknown for previously infected individuals and that vaccination can provide additional protection.
Information supporting vaccination after natural infections are:
- The vaccine provides a consistent and measurable dose of “inoculate” (immune producing agent) vs a natural infection where it is unknown.
- There is data supporting a heightened immunologic response for those infected and then receiving vaccination – called hybrid immunity.
- The data available for post-vaccinated protection will likely be more robust since it is easier to identify and monitor from a “vaccination event” versus a “confirmed SARS-CoV2 infection”.
Is it better for me to get natural immunity versus getting vaccinated immunity?
No – The consequences associated with a COVID-19 infection and its long-term consequences exceed the smaller risk of a serious adverse reaction to a COVID-19 vaccine.
Will the CDC provide additional guidance on natural immunity?
As more data and science becomes available, it’s reasonable to think more guidance will be forthcoming on natural immunity.
Promising new antiviral therapies for COVID-19
Oral antivirals could be the next game changer in the treatment of COVID-19. Two of the most promising recently released data from double-blinded trials showing a significant reduction in risk of hospitalization or death compared to placebo in non-hospitalized adult patients with COVID-19 who are at high risk of progressing to severe illness.
Merck’s molnupiravir works by introducing mutations into the viral genome during viral replication. Interim analysis of the MOVe-OUT trial shows a 50% reduced risk of hospitalization or death with molnupiravir compared to placebo. Pfizer’s Paxlovid acts by inhibiting an enzyme needed to process certain viral proteins into their final, functional form. The EPIC-HR trial preliminary data shows Paxlovid reduced the risk of hospitalization or death 89% compared to placebo. Due to these tremendous positive results, study enrollment has been stopped early for both trials. The FDA will evaluate Merck's molnupiravir on Nov. 30 and Pfizer plans to submit Paxlovid data through its on-going rolling submission with the FDA for Emergency Use Authorization (EUA).
Currently, neither agent may be taken as a preventative measure and are only for use by people who test positive for COVID-19 and are symptomatic. To best understand where these agents can be used, additional details are needed. Efficacy against variants of concern, the timing of treatment and correlation with efficacy to best determine the window of opportunity, safety, and potential drug resistance are all important factors that will help determine how these new oral anti-virals will impact the pandemic course.
Pfizer/BioNTech request FDA expansion of EUA for COVID-19 vaccine booster doses
Pfizer/BioNTech submitted efficacy and safety data from a Phase 3 trial along with a request last week to the FDA to expand the EUA to authorize boosters for all adults 18 and older. The FDA has not set a specific timeline for a decision on that request, but it is expected soon. If they do approve that request, the CDC will then weigh in on the expansion of eligibility. CDC advisers are scheduled to meet next on November 19.
