Medical experts continue to have active discussions on how best to combat the COVID-19 pandemic. Most recently, the advisory committees for the FDA and CDC had a robust and open discussion on the use of COVID-19 vaccine booster doses for a subset of fully vaccinated individuals. Despite the varying opinions expressed during these meetings, one thing has been clear with both committees - the importance of vaccinating first-time individuals and practicing non-pharmaceutical interventions.
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:
- CDC urgent alert regarding pregnant people and vaccination against COVID-19.
- The more transmissible Delta variant continues to account for 99% of the sequenced COVID-19 cases in the U.S.
- Pfizer/BioNTech COVID Vaccine (Comirnaty) receives FDA emergency use authorization (EUA) and the CDC endorsement for booster dosing.
- Moderna and Johnson & Johnson booster doses.
- Pfizer/BioNTech announce positive results with their COVID-19 vaccine in children 5 to 11 years.
- Data Journalism and the COVID-19 Pandemic: Opportunities and Challenges – Article in The Lancet.
CDC Urgent Action Recommendation in Pregnancy
The CDC released a Health Alert Network Advisory (HAN) recommending urgent action for accelerating COVID-19 vaccination among people who are pregnant (including those lactating), trying to become pregnant now, or may become pregnant in the future. The agency reports 161 pregnant women have died of COVID, with 22 deaths in August 2021 alone. The CDC emphasizes the benefits of vaccination against COVID-19 to prevent severe illness, death, and pregnancy complications related to COVID-19. With less than one-third of pregnant people being fully vaccinated against COVID-19, the agency urges healthcare providers to increase outreach efforts to pregnant people strongly recommending they receive an authorized or approved COVID-19 vaccination as quickly as possible.
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 99% of the sequenced COVID-19 cases in the U.S.
Booster Doses with Pfizer/BioNTech COVID Vaccine (Comirnaty)
The FDA recently amended the EUA for Comirnaty, allowing for a single-dose booster at least 6 months after the primary 2-dose series. The CDC recommends this booster for people 65 years of age and older, residents in long-term care settings or people 50 – 64 years of age with underlying medical conditions. People aged 18 – 49 years of age with underlying medical conditions and those 18 – 64 years of age who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may also receive the booster.
Booster Doses for Moderna and J&J COVID-19 Vaccines
Currently, Pfizer/BioNTech (Comirnaty) is the only COVID-19 vaccine with EUA for the administration of a booster. Moderna has initiated their FDA submission for a 50 µg dose booster given 6 months after the primary series of two 100 µg doses. Johnson & Johnson conducted two Phase 1/2a studies in people previously vaccinated with its single-shot vaccine demonstrating a booster dose generates a rapid and robust increase in spike-binding antibodies.
The following Ventegra COVID-19 Vaccine Grid provides a quick-reference resource for tracking vaccine types, series, boosters, and recommendations that will be updated regularly as additional information becomes available.
Findings recently published in the CDC Morbidity and Mortality Weekly Report indicate side effects from a third dose of Pfizer/BioNtech or Moderna COVID-19 vaccine so far appear similar to the second dose.
Pfizer/BioNTech COVID-19 vaccine for 5 to <12 years
Pfizer/BioNTech announced results from their pivotal COVID-19 vaccine trial in children 5 - <12 years of age, demonstrating a favorable safety profile and robust neutralizing antibody response using a two-dose series of 10 ug administered 21 days apart. This dosage is one-third (1/3) of the current two-dose series of 30 ug for people 12 and over. Pfizer/BioNtech has recently shared this data with the FDA for initial review and a formal submission request for EUA is expected within the following weeks.
Data Journalism and the COVID-19 Pandemic: Opportunities and Challenges
A commentary article (PDF version) written in the medical journal, The Lancet outlined how the demands for various analytics and real-time data due to pandemic has led to the development of non-traditional disease surveillance tools. The article concludes the need for rapid, accurate information during these outbreaks, the cross-collaboration between various stakeholders and how they should complement traditional public health efforts.
