COVID-19 updates
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The FDA proposed that each June the Vaccines and Related Biological Products Advisory Committee (VRBPAC) would meet and determine the composition of a COVID-19 vaccine to used as a booster or primary immunization in the fall. The FDA further proposed use of a bivalent vaccine for both primary and booster immunizations. Patients that have been immunized with a COVID-19 vaccine in the past would receive one vaccination. Patients who have not received a COVID-19 vaccination (i.e. young children) or those with a blunted immune response (i.e. elderly patients or immunocompromised patients) would receive two doses. The VRBPAC agreed and voted 21-0 to recommend a harmonized bivalent composition for COVID-19 for primary and booster vaccines.
In the 28-day, 26,411 patient, open-label, PANORAMIC trial, adding molnupiravir to usual care did not decrease hospitalization or mortality compared to placebo in vaccinated UK outpatients with mild-to-moderate COVID-19 at risk to progress to severe disease.
In a 28-day, 771 patient, Phase III trial (NCT05341609), oral remdesivir analogue, VV116 was non-inferior to nirmatrelvir–ritonavir in the percentage of patients that achieved sustained clinical recovery in Chinese adults with mild-to-moderate COVID—19 with at high risk to progress to severe disease. COVID-19 Vaccines
The FDA said that conclusions could not be drawn from pre-publication drafts of two recent studies, because both studies were small and had imitations. The studies from researchers at Harvard and Columbia did not find an increase in antibodies with the new bivalent COVID-19 booster compared to the original vaccine. Pfizer and BioNTech announced early interim data from a 900 patient, Phase II/III trial (NCT05472038), which demonstrated an increase in antibody titers, one-month after immunization with their bivalent booster vaccine, for the Omicron BA.4 and BA.5 subvariants by 13.2-fold in adults over 55 years and 9.5-fold in adults 18 to 55 years of age, compared to a 2.9-fold increase in adults over 55 who received the original booster vaccine Novavax announced that in a 14-day, 2,090 patient, Phase III trial (NCT05372588), a bivalent booster targeting the BA.1 and BA.5 omicron strains did not elicit more antibodies than Novavax’s current vaccine or a monovalent vaccine aimed solely at BA.1. COVID-19 Anti-inflammatories The FDA approved an emergency use authorization (EUA) for anakinra (Kineret, Sobi) to reduce the risk of progressing to severe respiratory failure in hospitalized COVID-19 adult patients with pneumonia requiring supplemental oxygen who are at risk of and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). The FDA amended the EUAs for the Moderna and Pfizer-BioNTech COVID-19 bivalent booster vaccines to include children and adolescents. Both vaccine can be given at least two months after the last booster vaccination. The Pfizer-BioNTech COVID-19 Vaccine is approved for patients five years and older. The Moderna vaccine is approved for patients six years and older.
Pfizer and BioNTech announced early interim data from a 900 patient, Phase II/III trial (NCT05472038), which demonstrated an increase in antibody titers for the Omicron BA.4 and BA.5-subvariants seven-days after immunization with their bivalent booster vaccine COVID-19 Update
The FDA has updated to the EUA for the COVID-19 monoclonal antibody combination of tixagevimab plus cilgavimab (Evusheld) to indicate that Omicron subvariant BA.4.6 is not susceptible to the antibody combination. In a 437 patient, Phase II/III trial (NCT04927065), Moderna’s bivalent COVID-19 vaccine, increased neutralizing antibodies against all Omicron subvariants, including BA.4 and BA.5 compared to the original Moderna vaccine in all participants regardless of prior infection.
A test-negative, case-control study by the CDC and academic partners, of 5,492 health care encounters for pregnant people, found the vaccine effectiveness (VE) for two doses to prevent COVID-19–associated emergency department and urgent care encounters during Omicron predominance was not significant, but VE for three doses was 79%. VE to prevent COVID-19 associated hospitalizations with was 86% for up to five months with two doses and up to four months with three doses. COVID-19 Vaccines
Pfizer and BioNTech have requested FDA an EUA for a bivalent vaccine, on 8/22/2022, containing the original Pfizer-BioNTech COVID-19 vaccine and a new Omicron BA.4/BA.5 variant vaccine. When approved, the companies are ready to start shipping the vaccine. Moderna requested an EUA for a similar bivalent vaccine a day later. Neither vaccine has any clinical trial data available, instead the NDA are based on preclinical and manufacturing data, as well as human studies of vaccines that incorporated the BA.1 omicron strain. The FDA authorized EUAs for bivalent vaccines from Moderna and Pfizer-BioNTech on 8/31/2022. The Moderna COVID-19 Vaccine is approved for patients 18 years and older. The Pfizer-BioNTech COVID-19 Vaccine, is approved for patients 12 years of age and older. The vaccines are given as a single booster dose at least two months following primary or booster vaccination. ACIP voted 13-1 to recommend the updated COVID-19 vaccine boosters, on 9/1/2022, and the CDC agreed and endorsed the vaccines the same day. COVID-19 Antivirals A review of data for 109,254 non-hospitalized, high-risk, COVID-19 patients found that use of nirmatrelvir reduced hospitalization in patients 65 and older (14.7 cases vs 58.9 cases per 100,000 person-days). However, in patients 40 to 64, there was no reduction (15.2 cases vs 15.8 cases per 100,000 person-days). Mortality was also reduced in older patients, but not in younger patients. COVID-19 Vaccines
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 12-to-0 to recommend Novavax’s COVID-19 vaccine for patients 18 and older on 7/19/2022. The CDC accepted the recommendation and endorsed use of the vaccine on the same day. An analysis of pediatric information from a large Israeli database found the vaccine effectiveness, for the Omicron variant, after two doses of the Pfizer-BioNTech COIVD-19 vaccine to be 51% to prevent infection and 48% to prevent symptomatic COVID-19. An analysis of data on children in Singapore found the vaccine effectiveness, for the Omicron variant, after two doses of the Pfizer-BioNTech COIVD-19 vaccine to be 65.3% to prevent infection and 82.7% to prevent COVID-19 hospitalization. COVID-19 Antivirals A Japanese in-vitro evaluation of COVID-19 treatments found that remdesivir, molnupiravir, and nirmatrelvir retain activity against the BA.2.12.1, BA.4, and BA.5 omicron variants. Bebtelovimab was found to be effective against BA.2.12.1, BA.4, and BA.5. The subvariants are less susceptible to sotrovimab and combination therapy with casirivimab and imdevimab and with tixagevimab and cilgavimab. COVID-19 Vaccines
The FDA issued an EUA for the Novavax COVID-19 Vaccine, on 7/13/2022, to prevent COVID-19 in patients 18 years of age and older. The Novavax COVID-19 Vaccine is administered as a two-dose primary series given three weeks apart. Johns Hopkins’ researchers prospectively followed rheumatic and musculoskeletal diseases and solid organ transplant recipients patients who had been vaccinated with either the Pfizer-BioNTech or Moderna COVDI-19 vaccines. While the immune response was similar in patients not receiving immunosuppression the response was higher with the Moderna vaccine in patients receiving immunosuppressive drugs. Moderna announced that an experimental COVID-19 bivalent vaccine containing a combination of the original vaccine and an Omicron BA.1 subvariant specific vaccine, elicited antibody levels for Omicron BA.4 and BA.5 subvariants that were 1.69 times higher than the original vaccine. Moderna is also developing a vaccine targeting the Omicron BA.4 and BA.5 subvariants. COVID-19 Antivirals The FDA rejected a request for an EUA for aviptadil to treat critical COVID-19 with respiratory failure and to treat COVID-19 patients, in November 2021. In June 2022, the FDA rejected a request for an EUA for aviptadil to treat COVID-19 respiratory failure patients who continue to worsen, despite treatment with remdesivir. COVID-19 Anti-Inflammatories Humanigen announced that in the 29-day, 473 patient, NIAID sponsored, Phase II, ACTIV-5/BET-B trial(NCT04583969), adding lenzilumab to remdesivir did not reduce the need for mechanical ventilation compared to remdesivir monotherapy in hospitalized patients with COVID-19. Sabizabulin is an oral microtubule disruptor being developed by Veru as a treatment for metastatic castration-resistant prostate cancer. Because sabizabulin has been shown to have antiviral effects on the S protein-microtubule trafficking and anti-inflammatory effects, Veru is evaluating the drug as a treatment for cytokine release syndrome (cytokine storm) induced by COVID-19.
COVID-19 Vaccines
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. |
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