Both companies quoted preliminary results from the first randomized controlled trial on boosters on Thursday, with BioNTech / Pfizer vaccine booster shots 95.6% more effective against Covid-19 compared to two shots and placebo. Said that.
Ugur Sahin, Head of BioNTech, added “important data” to a set of evidence suggesting that booster doses may help “protect a wide range of people from this virus and its variants.” Stated.
“Based on these findings, in addition to the worldwide availability of vaccines for all, booster vaccination can play an important role in maintaining pandemic containment and return to normal. I think it’s sex, “he said.
In a study of 10,000 participants who all completed a two-shot Pfizer regimen, half were randomized, more shots of the same intensity were given, and half were placebo. Five Covids were enrolled in booster-treated patients compared to 109 who received placebo.
The study was conducted during the period when the delta coronavirus mutant was widespread, with a median duration of approximately 11 months and a median follow-up of 2.5 months between the second and third doses. bottom.
Andy Hill, a senior visiting researcher in pharmacology at the University of Liverpool, said the trial was “very important” because it provided a “much stronger” level of evidence.
“It’s randomized and measures the effect on new infections. This is a big step forward from previous studies of other vaccines that only measured the effect on antibody levels,” Hill said. increase. “This new exam is much more reliable.”
But Ameshua Darha, a senior scholar at the Johns Hopkins Center for Health and Security, said it is still unclear how long boosters can be protected “when antibody levels drop.”
“Does this just push up the breakthrough? [infections post vaccination] Off at a later date? Is second-generation vaccination, which produces more nasal immunity, a real solution to a breakthrough problem? “Adalja said. “The virus is always here, and I’m not sure if it’s worth it to chase a mild breakthrough with intermittent booster immunizations of first-generation vaccines.”
The median age of participants was 53 years, more than half of the 16-55 year group. More than one-fifth are over 65 years old, a category with a high risk of severe Covid. The two companies noted that multiple subgroup analyzes showed that relative efficacy was “consistent” regardless of age, gender, race, ethnicity, or other underlying condition.
He added that the vaccine safety profile is “generally consistent” with other available data and will share information with the US, EU and other regulatory agencies.
Marco Cavaleri, head of the Vaccine Strategy Division of the European Medicines Agency, said the European Medicines Agency will evaluate the data as part of a broader assessment of boosters.
He refused to comment directly on studies that had not yet been peer-reviewed, but told reporters Thursday that the review was “very important” in informing reporters of the vaccination campaign.
Discussion over boosters It’s a painThis year, companies such as Pfizer and BioNTech have split the scientific community this year as companies such as Pfizer and BioNTech have stated that the protection provided by the vaccine has diminished over time, especially against Covid caused by the delta variant. But, importantly, booster data from randomized controlled trials, the gold standard for drug research, was not available until Thursday.
Wednesday US Food and Drug Administration Gave green light Boosts can be combined and combined so that US citizens at high risk of becoming infected with Covid can receive more shots of the approved vaccine.
High-income countries, including Israel, the United Kingdom, the United States and EU countries, have begun to deploy boosters to their populations to ensure they remain protected during the winter when transmission is supported by indoor mixing. rice field.
For comparison, immunization rates in low-income countries are consistently lagging. Only 2.8 percent of people in these countries receive at least one vaccination.
Additional report by Jamie Smith in New York
Pfizer Booster Shows 95.6% Efficacy Against Covid, Studies Show
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