COVID-19 Update #83 for 5/19/2021

COVID-19 Vaccines 
 
The CDC’s Advisory Committee on Immunization Practices (ACIP) recommended use of the Pfizer-BioNtech vaccine to adolescents 12 to 15 on 5/14/2021.
 
Researchers from Pfizer, BioNTech and the University of Texas tested antibodies from the Pfizer-BioNTech COVID-19 vaccine against the new COVID-19 variants, B.1.526, B.1.429, and B.1.1.7+E484K. In the lab tests the antibodies were able to neutralize all three variants.
 
A pre-publication draft describes an analysis by British researchers of 175 patients, who were 80 or older and received the Pfizer-BioNTech COVID-19 vaccine. Patients received the second dose at the standard 3-week interval or at an extended 12-week interval. The 12-week interval produced antibody titers that were 3.5-fold higher, but the cellular immune responses was 3.6-fold lower.
 
The EMA recommended extending the storage time for the Pfizer-BioNTech COVID-19 vaccine from five days to 31 days at normal refrigerator temperatures. In the U.S. the vaccine may be kept at standard freezer temperature for up to two weeks.
 
A retrospective study by Yale identified 16 patients that developed a delayed localized cutaneous reactions 2 to 12 days after receiving the Moderna COVID-19 vaccine. The reaction was near the injection site and was pruritic and painful with edematous pink plaques. The reaction developed in 11 of the patients with the second dose. The reaction was also seen in a small number of patients during the pivotal COVE trial. The reaction had a duration of five days.
 
Researchers examined data from 30 pregnant, 16 lactating, and 57 non-pregnant/non-lactating patients and found the mRNA vaccine response was equivalent for pregnant and lactating women compared to non-pregnant/non-lactating women. Further, the immune transfer to neonates occurred via placental and breastmilk. Pregnant and lactating women also developed neutralizing antibodies that were active against the B.1.1.7 (U.K.) and B.1.351 (South African) variants.
 
CDC researchers analyzed the outcomes in 1,843 health care professionals and found the mRNA vaccines’ efficacy to be 82% in preventing COVID-19 after one dose and 94% after two doses.
 
Animal studies suggest that an influenza-COVID-19 combination vaccine would elicit antibodies for both viruses at levels similar to that seen with the individual vaccines. The vaccine also prevented infection from a virus challenge.
 
Novavax will delay seeking an EUA for its COVID-19 vaccine to July 2021 due to manufacturing issues that include a quality control assay and problems with supplies needed to grow cell cultures.
 
On 5/12/2021, the CDC announced it had identified 28 cases of thrombosis with thrombocytopenia among 8.7 million patients that received the J&J COVID-19 vaccine and considers the relationship between the vaccine and the adverse event to be a "plausible causal association".
 
Sanofi and GSK announced interim results from a 722 patient, Phase II trial (NCT04762680), where the companies’ COVID-19 vaccine elicited antibody levels comparable to recovered patients following a second dose in all age groups (18 to 95 years old) of patients from the U.S. and Honduras. Based on the interim results from the Phase II trial, Sanofi and GSK are planning to initiate a 35,000 patient Phase III trial with the goal of submitting data for an emergency use authorization (EUA) in 4Q21.
 
A pre-publication draft describes interim results from a 588 patients enrolled in the Phase II portion of a Phase II/III trial (NCT04636697), where the Medicago COVID-19 vaccine (CoVLP) with GSK’s AS03 vaccine adjuvant elicited antibody titers after a second dose in all adult age groups that were ten times higher than a panel of recovered COVID-19 patients.
 
COVID-19 Antivirals
 
Due to the volume of press releases from CytoDyn, the FDA provided a “Statement on Leronlimab” stating that neither an 86 patient trial in mild-to-moderate COVID-19 infection, nor a 394 patient trial in patients with severe disease provided evidence to support a benefit in using leronlimab in the treatment of COVID-19. The FDA does not feel that a positive finding in a sub-group supports use of the drug, rather it suggests design parameters for a new trial.