[ad_1]
Sputnik V’s interim analysis came after researchers identified 20 cases of Covid-19 among participants in the Phase 3 trial who received the vaccine or a placebo, according to a press release from the Investment Fund Russian Direct (RDIF), which funded and is responsible for vaccine production. to sell it all over the world.
According to the RDIF press release, no unexpected adverse events were identified during the phase 3 trial. Some who received the Russian vaccine, which was developed by the Gamaleya Institute, had adverse effects minor short-term such as pain at the injection site, flu syndrome including fever, weakness, fatigue and headache.
The Russian Phase 3 trial will continue for an additional six months, and data from the trial will be published in an international medical journal following peer review, RDIF said in a statement.
Apart from the ongoing phase 3 trials, the vaccine was first administered in September to a group of volunteers from the “red zones” of Russian hospitals. Ten thousand vaccinated volunteers, including doctors and other high-risk groups, have been observed, said RDIF, and “have confirmed the vaccine’s effectiveness rate of over 90%.”
But Dr Peter Hotez, an infectious disease specialist at Baylor College of Medicine who is also developing a vaccine for the coronavirus, told CNN he doubts the 20 cases of Covid-19 are enough to give a solid view of the disease. effectiveness of Sputnik V.
“Intuitively, it doesn’t make sense to claim 92% protection just on the basis of 20 events. But we’ll have to see the data,” he said. “Regulators need to see the data and a regulator that has experience should look at data like the EMA, the European Medicines Agency. They are the ones who really need to look at that and say, well, you know, this is too small, really, for you to say it is 92% effective. “
RDIF’s announcement follows an announcement by Pfizer and BioNTech on Monday that their Covid-19 vaccine was more than 90% effective based on early analysis of its data. Their interim analysis followed more than 90 confirmed cases of coronavirus among trial participants. More than 43,530 participants were enrolled in the Phase 3 trial and 38,955 volunteers received a second dose, Pfizer said Monday.
The two vaccines are different. Pfizer is based on a messenger RNA platform, a vaccine technology never approved before, while RDIF is based on an inactivated adenoviral vector. One of the advantages of adenoviral vaccines is that they don’t need to be stored and transported in extremely cold temperatures, scientists say.
But Hotez warns that regardless of the vaccine’s makeup, drugmakers risk getting ahead of the curve by making efficacy claims at this point.
“I would say that no announcement should have been made. That’s not how we do it. The way we do this is by submitting the file to the regulators. The regulators allow it, or allow it, Either approve it. And then you go ahead, and you can release that information to the public with the clinical trial data out of the box, ”he added.
Martin McKee, professor of European public health at the London School of Hygiene and Tropical Medicine, told CNN that Pfizer initially scheduled an interim analysis on only 32 positive cases, but the FDA said that was not enough.
McKee agreed that 20 positive cases were a weak basis for analysis in the Sputnik V case, but nonetheless expressed “cautious optimism” about Russia’s announcement. It all depends on the number of people included in the trials and the prevalence of infection in the communities where the trials are taking place, he said.
More than 20,000 people received their first dose of Sputnik V vaccine in the phase 3 trial, and 16,000 participants received the second dose, according to RDIF.
“I think [RDIF] know they have to get it validated and they said in the press release that they will publish the major international journals. So they will have to do it and these reviews will not accept anything without fairly rigorous data checks. They are well aware of this, they must not make any mistakes, ”McKee said.
RDIF told CNN that Russia will release the clinical trial protocol for Sputnik V in November and that the next interim analysis will look at 39 cases of the coronavirus.
Russia drew criticism from scientific circles earlier this year, when it announced the world’s first approved coronavirus vaccine for public use in August – even before the crucial Phase 3 trials were completed.
The results of the first human tests of Sputnik V were published in The Lancet in September. Only 76 people were involved in the first two trials – too few to determine whether the Russian vaccine was safe and effective. But the peer-reviewed report says only mild side effects were reported and the vaccine elicited an immune response in trial participants.
Eleanor Riley, professor of immunology and infectious diseases at the University of Edinburgh, urged all vaccine manufacturers to put quality and safety above speed.
RDIF’s announcement of Sputnik V’s interim analysis is “encouraging,” she said in a statement to the UK’s Science Media Center. However, she added, “I’m concerned that this data may have been released following Pfizer / BioNtech’s announcement earlier in the week.”
“This is not a competition,” she also said, expressing the concern of many in the scientific community.
“We need all testing to be conducted to the highest possible standards and it is especially important that the pre-defined criteria for waiving test data blindness are met to avoid selecting data accurately. Anything less than that risks losing public confidence in all vaccines, which would be a disaster. “
[ad_2]
Source link