Two new articles regarding Covid 19 vaccine. The first is from Bloomberg News on Pfizer’s vaccine. The second is from today’s New England of Journal which shows the efficacy of Covid 19 vaccine boosters in preventing Omicron. Boosters were more effective, but a more Omicron specific vaccine is expected.
Pfizer to Submit Data to FDA on Fourth Covid Shot Soon, CEO Says
(Bloomberg) — Pfizer Inc. will soon submit data to U.S. regulators on a fourth dose of its Covid-19 vaccine, Chief Executive Officer Albert Bourla said.
Bourla said he spent Tuesday morning reviewing new data from various Covid vaccine studies, including one looking at the effects of a fourth dose of the currently available vaccine, as well as a new formulation that will protect against multiple coronavirus variants.
“They look encouraging,” Bourla said in an interview on Bloomberg Television’s “Balance of Power With David Westin,” noting that Pfizer still needs to collect more information.
Pandemic concerns are abating as the omicron surge in cases has faded over the past few weeks. Still, the ability of the coronavirus to mutate suggests that more vaccines and boosters will be needed to control future variants as they arise.
The CEO anticipates that Pfizer will approach the U.S. Food and Drug Administration either this month or in early April with the data on a fourth dose that may help restore immunity, in addition to results from a study of a version that specifically targets the omicron variant. The shots were developed in collaboration with BioNTech SE, based in Germany.
Pfizer’s studies of both the fourth-dose booster and the omicron-specific shot are still underway, spokeswoman Jerica Pitts said. Once all the data are available, the company will analyze it and share insights with health authorities and regulators, she said.
Bourla said he’s optimistic about developing a vaccine that would target omicron along with earlier variants, but didn’t provide a timeline for results. Findings from a study of a three-dose regimen of the company’s vaccine for children under the age of 5 are also expected next month, he said.
Waning of vaccine protection against coronavirus disease 2019 (Covid-19) and the emergence of the omicron (or B.1.1.529) variant of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have led to expedited efforts to scale up booster vaccination. Protection conferred by booster doses of the BNT162b2 (Pfizer–BioNTech) and mRNA-1273 (Moderna) vaccines in Qatar, as compared with protection conferred by the two-dose primary series, is unclear.
We conducted two matched retrospective cohort studies to assess the effectiveness of booster vaccination, as compared with that of a two-dose primary series alone, against symptomatic SARS-CoV-2 infection and Covid-19–related hospitalization and death during a large wave of omicron infections from December 19, 2021, through January 26, 2022. The association of booster status with infection was estimated with the use of Cox proportional-hazards regression models.
In a population of 2,239,193 persons who had received at least two doses of BNT162b2 (Pfizer–BioNTech) or mRNA-1273 (Moderna) vaccine, those who had also received a booster were matched with persons who had not received a booster. Among the BNT162b2-vaccinated persons, the cumulative incidence of symptomatic omicron infection was 2.4% (95% confidence interval [CI], 2.3 to 2.5) in the booster cohort and 4.5% (95% CI, 4.3 to 4.6) in the nonbooster cohort after 35 days of follow-up. Booster effectiveness against symptomatic omicron infection, as compared with that of the primary series, was 49.4% (95% CI, 47.1 to 51.6). Booster effectiveness against Covid-19–related hospitalization and death due to omicron infection, as compared with the primary series, was 76.5% (95% CI, 55.9 to 87.5). BNT162b2 booster effectiveness against symptomatic infection with the delta (or B.1.617.2) variant, as compared with the primary series, was 86.1% (95% CI, 67.3 to 94.1). Among the mRNA-1273–vaccinated persons, the cumulative incidence of symptomatic omicron infection was 1.0% (95% CI, 0.9 to 1.2) in the booster cohort and 1.9% (95% CI, 1.8 to 2.1) in the nonbooster cohort after 35 days; booster effectiveness against symptomatic omicron infection, as compared with the primary series, was 47.3% (95% CI, 40.7 to 53.3). Few severe Covid-19 cases were noted in the mRNA-1273–vaccinated cohorts.
The messenger RNA (mRNA) boosters were highly effective against symptomatic delta infection, but they were less effective against symptomatic omicron infection. However, with both variants, mRNA boosters led to strong protection against Covid-19–related hospitalization and death. (Funded by Weill Cornell Medicine–Qatar and others.)