An FDA review of data available for the Omicron variant vaccines from Moderna and Pfizer-BioNtech found that both vaccines improved the neutralizing antibody response to Omicron BA.1. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 19-2, on 6/28/2022, to recommend incorporating a component of the omicron variant into future COVID booster vaccines. The Omicron BA.4 and BA.5 subvariants now comprise more than 50% of COVID-19 cases. If the FDA requests a new booster vaccine to include these variants, Moderna and Pfizer-BioNTech would be able to create the vaccines by October. VRBPAC recommended a new booster be bivalent and contain BA.4 or BA.5 subvariants of Omicron.
A case–control test-negative study by the CDC found vaccine effectiveness to prevent COVID-19 hospitalization in infants born to mothers immunized with an mRNA vaccines to be 80% during the Delta variant dominant period and 38% during the Omicron dominant period. Administration, of the second COVID-19 vaccine dose after 20 weeks of pregnancy was more effective than when given before the first 20 weeks (69% vs. 38%).
An in-vitro analysis of neutralizing antibody titers in serum from 27 patients that had received two doses of the Pfizer-BioNTech COVID-19 vaccine and 27 patients who had been infected with the BA.1 or BA.2 subvariant found that titers were lower for BA.2.12.1, BA.4, and BA.5 subvariants than BA.1 and BA.2.
FDA reviews of the Moderna and Pfizer- BioNTech mRNA COVID-19 vaccines found them to be as effective for children 6 months to 5 years as in older children and young adults. No cases of myocarditis were experienced in this age group during trials.
• 76.8% for children 6 to 11 years
• 36.8% for toddlers 2 to 5 years
• 50.6% for infants 6 to 23 months
Note: Only the results for children 6 months to 5 years were during an Omicron dominant period. The results are based on preliminary results and may not represent the actual effectiveness.
The FDA expanded use of both mRNA vaccines to all patients 6 months and older. The CDC expanded their COVID-19 vaccination recommendations to include the same age groups.
An analysis of data from a Qatar healthcare database found effectiveness against the Omicron BA.2 variant to be:
Sanofi and GSK announced that in the 247 patient, Phase III, COVIBOOST trial (NCT05124171), a booster dose after two doses of the Pfizer-BioNTech COVID-19 vaccine resulted in a 10-fold increase in antibody titers in:
Pfizer announced that in the 28-day, 1,153 patient, Phase II/III, EPIC-SR trial (NCT05011513), treatment with nirmatrelvir plus ritonavir did not increase resolution of symptoms compared to placebo in patients with COVID-19, who were at standard risk for developing severe COVID-19.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21-0 with one abstention to recommend an EUA for Novavax’s two-dose COVID-19 vaccine for patients 18 years and older. An FDA review and the discussion by the VRBPAC expressed concern about myocarditis, although the adverse effect appears to be rare.
Moderna announced interim data from a Phase II/III trial where an investigational bivalent COVID-19 vaccine containing a combination of the original vaccine and an Omicron variant specific vaccine elicited higher antibody levels for both the original SAR-COV-2 virus and the Omicron variant.
A systematic review and network meta-analysis of 38 WHO COVID-19 databases comprising 53 studies found that a three dose regimen of an mRNA COVID-19 vaccine is most effective for prevention of COVID-19. This includes patients who are immunocompromised and/or older than 65 years.
The FDA has provided additional information about use of Paxlovid in a 5/4/2022 posting. The FDA addresses reports of rare infection recurrences after completing a course of the drug combination. A re-analysis of Paxlovid data found that while 1-2% of patients may test positive after treatment, it was unclear whether this was a drug effect, because the same results were seen in placebo patients (tested negative, then tested positive). Based on limited information, the CDC found that COVID-19 rebound usually occurs 2 to 8 days after initial recovery and include COVID-19 symptoms or a new positive viral test after having tested negative. The natural course of COVID-19 may include a brief return of symptoms, regardless of treatment or vaccine status. Current cases of rebound COVID-19 rebound after Paxlovid have been mild. There is no evidence to support use of the Paxlovid beyond five days, but the CDC recommends following Guidance on Quarantine and Isolation.
In the 29-day, 1,047 patient, Phase III, ACTT 4 trial (NCT04640168), mechanical ventilation-free survival was similar between baricitinib plus remdesivir and dexamethasone plus remdesivir (87% vs 87.6%) in hospitalized patients with COVID-19. There were more treatment related adverse events and severe or life-threatening adverse events with dexamethasone plus remdesivir.
Stay informed, subscribe to the Prescribe Right Pharmaceutical Pipeline Tracker