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modern On Wednesday, COVID-19 announced new data supporting booster vaccines, observing a higher risk of new infections and reduced immunity in people who have already received their first dose of vaccine.
One trial called COVE had 88 breakthrough infections among 11,431 participants who received their first shots of the mRNA vaccine between December and March, or 59 cases per 1000 person-years. Of the 14,746 participants who received their first dose between July and October 2020, 162 experienced a breakthrough infection with a rate of 77.1 cases per 1,000 person-years. Participants who were vaccinated more recently had a 36% lower incidence rate than those vaccinated before. modern‘s analysis found.
Trial researchers observed only 19 serious breakthrough infections and noted a lower rate of serious cases for the more recently vaccinated group, 3.3 per 1,000 person-years compared to 6.2 per 1,000 people.
“The increased risk of contagious infections in COVE study participants who were vaccinated last year compared to more recently demonstrates the impact of weakened immunity and supports the need for a booster to provide high levels of protection,” said Stéphane Bancel, CEO. modern, in a statement. We hope these findings are helpful as health officials and regulators continue to evaluate strategies to end this pandemic.”
The results come from the ongoing phase three trial. US Food and Drug Administration examined when given modern emergency use authorization for the vaccine. Participants in the trial received either a placebo or modern‘Coronavirus Vaccine.
modern posted the findings to the medRxiv server as a preprint. The study has not yet been peer-reviewed.
Data from Pfizer’s booster dose, released Wednesday, found that people who received their second COVID-19 vaccine at least eight months before July had a higher incidence of breakthrough cases than those who received their second dose with fewer than four. months before July.
“The aggregate of available data supports the public health need for a booster (third) dose of BNT162b2 approximately 6 months after the second dose of BNT162b2 for individuals 16 years of age and older,” Pfizer said in its filing with the FDA.
Pfizer said its data showed that the third dose of vaccine administered approximately six months after the second dose had “an acceptable safety profile and elicited robust immune responses” against the original coronavirus and Beta and Delta strains. The vaccine manufacturer also cited data from Israel that found that a booster dose of its vaccine provided a high level of protection against COVID-19, returning up to 95% effectiveness.
An FDA advisory committee will meet on Friday to review data on boosters and decide whether extra vaccines are needed.
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