On 5/19/2021, the FDA approved storage of the Pfizer-BioNTech COVID-19 vaccine at refrigerator temperatures for up to 30 days.
Moderna announced that in the 3,732 patient, Phase II/III TeenCOVE trial (NCT04649151), no cases of COVID-19 were reported among adolescents ages 12 to 17 years that received two doses of the Moderna COVID-19 vaccine compared to the placebo group in the adult Phase III COVE study. Efficacy was 93% when measured 14 days after the first dose. The vaccine was well tolerated with no serious adverse events.
The World Health Organization announced that COVID-19 vaccines currently approved in the U.S. and Europe are effective against virus variants. This includes the B.1.617 (India), B.1.351 (South Africa), B.1.1.7 (U.K.) and P.1 (Brazil).
A review of outcomes in British patients over 70, found vaccine effectiveness after one dose, at 28 to 34 days, to be 61% with the Pfizer-BioNTech vaccine and 60% with the Astra Zeneca vaccine. The vaccines provided approximately 80% protection against hospital admission. Effectiveness after a second dose of the Pfizer-BioNTech vaccine was estimated at 90% in patients 80 and older. No estimate was provided for effectiveness after a second dose of the Astra Zeneca vaccine.
In the 28-day, 4,116 patient, Phase III, DISCOVERY trial (NCT04381936), adding tocilizumab to usual care resulted in 31% mortality compared to 35% with usual care alone in hospitalized adults with COVID-19 with oxygen saturation < 92% or requiring oxygen therapy and C-reactive protein of 75 mg/L or >. Corticosteroids were used in 82% of the study population.
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.
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.
The FDA expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age. The previously announced 2,260 patient, Phase III trial, found 100% efficacy with no cases of COVID-19 in patients 12 to 15 immunized with their COVID-19 vaccine compared to 18 cases in the placebo group. The FDA has updated the Fact Sheets for Healthcare Providers and Patients and Caregivers with information to reflect the use of the vaccine in adolescents.
Pfizer and BioNTech are working on a new formulation of their COVID19 vaccine that will be stable at refrigerator temperatures (2 to 8 degrees C) for six months. Moderna has reported a new formulation that is stable for three-months at 2 to 8 degrees C.
Moderna announced that preliminary data from a 40-patient trial suggested that booster injection with either the original Moderna COVID-19 vaccine or a new vaccine targeting the B.1.351 (South African) variant increased antibodies against that variant and the P.1 (Brazil) variant. All participants were previously fully vaccinated with Moderna’s vaccine. The new vaccine is designed to elicit antibodies for the B.1.351 variant eliciting higher titers of antibodies for the variant.
Moderna announced preliminary data from the Phase II/III TeenCOVE trial (NCT04649151) suggested 96% efficacy in adolescents ages 12 to 17 years. The vaccine was well tolerated with no serious adverse events.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is examining whether the Pfizer-BioNTech COVID-19 vaccine increases the risk for myocarditis. PRAC has also asked Moderna for data. Neither the CDC nor PRAC have found an association for myocarditis with current data.
Researchers in Qatar estimated the efficacy of the Pfizer–BioNTech COVID-19 vaccine as 89.5% against the B.1.1.7 (U.K.) variant and 75% for the B.1.351 (South Africa) variant. For severe, critical, or fatal disease due to the B.1.1.7 or B.1.351 variants, efficacy was 97.4%. During data collection, 50% of cases were from the B.1.1.7 variant and 44.5% from the B.1.351 variant.
In a 4,387 patient, Phase IIb trial (NCT04533399), where two doses of the Novavax COVID-19 vaccine given 21-days apart resulted in 49.4% efficacy in a South African population. Most cases of COVID-19 were the B.1.351 (South African) variant. The trial population included medically stable, HIV-positive adults. Efficacy was 60.1% among HIV negative patients.
Adagio Therapeutics is developing ADG20, a monoclonal antibody directed at a binding site not identified to mutate. ADG20 is being developed in a high concentration solution for intramuscular injection with a long duration of action to prolong immunity.
The U.S. will share its stockpile of the AstraZeneca COVID-19 vaccine with other countries. Up to 60 million doses are expected to be available.
In the 23,324 patient, SIREN trial, the Pfizer-BioNTech COVID-19 vaccine was 70% effective 21 days after the first dose and 85% effective seven days after the second dose in British health care professionals. The dominant variant in circulation during the study was the B1.1.7 (U.K.) variant.
In Scotland, the second dose of a COVID-19 vaccine is given 12-weeks after the first dose. An analysis of 1,331,993 patients, found the Pfizer-BioNTech COVID-19 vaccine was 91% effective and the AstraZeneca vaccine was 88% effective in preventing hospital admission for COVID-19 28–34 days after vaccination. In patients 80 and older, the vaccines were 88% and 81% effective.
Researchers analyzed data from the World Health Organization pharmacovigilance database and identified 0.6% of adverse events with the mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna) as facial paralysis-related events (e.g., paralysis, paresis, spasms). Most events were linked to the Pfizer-BioNTech vaccine. This compares to 0.5% with other viral vaccines and 0.7% with the influenza vaccines. The researchers concluded that if an association with facial paralysis exists, it would be very low and similar to other viral vaccines.
Researchers analyzed data from 417 patients, who were 65 or older and hospitalized with COVID-19 symptoms. 187 patients tested positive for COVID-19, while 230 were negative. When examining the impact of vaccination in preventing COVID-19 infection, efficacy was estimated to be 94% for fully vaccinated patients and 64% for patients that only received the first dose of the Pfizer-BioNTech or Moderna COVID-19 vaccines.
Synairgen announced that in a 28-day, 120 patient, Phase II trial (NCT04385095), only two patients in the placebo group advanced to hospitalization compared to none in the nebulized interferon beta-1a group in high risk, British outpatients with COVID-19. Due to the low incidence of hospitalizations, prevention of progression to severe COVID-19 could not be calculated. An analysis of a small group of patients with severe breathlessness suggested that use of nebulized interferon beta-1a may help patients recover more quickly. When combining all patients who were markedly or severely breathless in both the home treatment cohort and hospital treatment cohort, treatment with nebulized interferon beta-1 increased the likelihood of recovery.
Roche and Atea Pharmaceuticals are developing AT-527, as an oral antiviral treatment for Covid-19. The therapy works by blocking the viral RNA polymerase enzyme needed for viral replication.
Lilly and AbCellera are developing LY-CoV1404, a monoclonal antibody targeting mutated region of the SARS-CoV-2 spike protein. A preclinical study has shown the antibody can neutralize all known variants (B.1.1.7, B.1.351, B.1.427/B.1.429, P.1, and B.1.526). LY-CoV1404 is being evaluated as part of the Phase III, BLAZE 4 trial (NCT04634409) in patients with mild to moderate COVID-19.
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