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On November 9, US-based Pfizer announced the results of an interim analysis that “more than 90% efficacy was confirmed” in a large-scale clinical trial of a new coronavirus vaccine developed jointly with Germany’s Biontech (Reuters) .
[Chicago / London Reuters]The results of the interim analysis of the phase 3 (P3) clinical trial of the new coronavirus vaccine candidate announced by Pfizer in the US and Biontech in Germany far exceeded expectations, but many questions remained. still.On November 9, the two companies had a preventive effect of more than 90% in the P3 study of the new coronavirus vaccine candidate “BNT162b2”, which is being jointly developed, based on data at the time. that infection was confirmed in 94 of the subjects. He announced that it was confirmed. As soon as the necessary safety data is available, an emergency use permit will be requested from the US FDA (Food and Drug Administration) within a month.
The P3 trial, which recruited approximately 44,000 people, was initially scheduled for the first interim analysis when 32 of the subjects developed a new coronavirus infection. In an interview, Dr. William Gruber, senior vice president of vaccine development at Pfizer, said in an interview that discussions with US regulators changed the test plan and ultimately yielded data for 94 people.
“This result gives us more power and confidence,” said John Moore, professor of microbiology and immunology at Weil Cornell Medical College (New York). “When the numbers triple, between the vaccine and the placebo.” If there is a big difference, the effect is much more likely to be genuine. “
On the other hand, researchers should note that there are still many questions about whether the vaccine can prevent aggravation and complications, how long it can prevent infection, and how effective it is for the elderly. The voice is also increasing.
They note that the required security data will not be available until the end of this month. Furthermore, the data published this time has not undergone peer review.
“Reassuring, but first results”
“It’s a really encouraging result, but it’s just an early result,” said Dr. Gregory Poland, a virus and vaccine researcher at the May York Clinic in Rochester, Minnesota. The P3 study will continue until 164 of the subjects are confirmed to be infected.
Pfizer said the FDA advisory board, which will consider allowing emergency use based on this data, could meet in early to mid-December.
The company’s Gruber said it is not yet known how many black and Latino people have high infection and death rates among the 94 confirmed infections. On the other hand, the number of older people is precisely known. Older people with weakened immunity are also vulnerable to the new corona virus.
In the first 94 cases, no one developed a new serious coronavirus infection. Initially, the FDA required the interim analysis to include at least five serious cases, but recently the requirement has been relaxed, Gruber said.
Eleanor Riley (Immunology and Infectious Diseases) from the University of Edinburgh, UK, said: “Vaccines are effective for the elderly in reducing severe cases and deaths and allowing people to return to normal life.” It must be something like that. “
Gruber predicts that there will be multiple severe cases at the end of the study, “the bottom line is confidence to use highly effective data to prevent serious infections. Give.”
The researchers also want to know whether the Physer and Biontech vaccines completely prevent infections (which is a great advantage in reducing infections) or simply reduce the degree to which they get sick.
“It would be ideal if we could completely prevent infection, but we all agree that so-called first-generation vaccines are more likely to prevent it,” said Lawrence Young, a professor at the University of Warwick. “The important thing is that if you are infected, you can spread the virus,” he said.
Pfizer intends to seek broad approval for people ages 16 to 85, but the FDA and CDC (Center for Disease Control) advisory committee will initially decide who should receive the low-supply vaccine. Be.
If Pfizer obtains an emergency license, Gruber will be ethically obligated to notify placebo subjects that they are not protected against infection and to provide vaccines to prevent withdrawal from the study. He said he felt he was.
（Julie Steenhuysen / Kate Kelland 、 翻 訳 ： AnswersNews）
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