According to a press release from the Russian Direct Investment Fund (RDIF), researchers conducted an interim analysis of Sputnik V after identifying 20 Covid-19 cases among participants in the Phase 3 trial who received the vaccine or placebo. Worldwide sales.
According to the RDIF press release, no unexpected adverse events were found in the phase 3 trial. Some people who received the Russian vaccine developed by the Gamaleya Institute experienced short-term minor adverse events, such as pain at the injection site, flu-like syndrome (including fever, weakness, fatigue, and headache).
RDIF said in a statement that Russia’s Phase III trial will continue for six months, and the trial data will be published in international medical journals after peer review.
Separately from the ongoing Phase 3 trial, the vaccine was first administered to a group of volunteers from the “red zone”
However, Dr. Peter Hotez, an infectious disease expert at Baylor College of Medicine, is also developing a coronavirus vaccine. He expressed doubts about CNN. He suspects that these 20 Covid-19 cases are sufficient for the efficacy of Sputnik V. Reliable understanding.
He said: “Intuitively speaking, claiming 92% protection based on only 20 incidents is meaningless. However, we must see the data.” “Regulators need to view the data, and experienced regulators should review it. Data from EMA, European Medicines Agency, etc. They are the ones who really need to study and say this. It is too small, you said that the effective rate is 92%.”
Before the RDIF announcement, Pfizer and BioNTech announced on Monday that, based on an early analysis of their data, they found that their Covid-19 vaccine was more than 90% effective. Their interim analysis was performed after more than 90 confirmed cases of coronavirus among trial participants. Pfizer said on Monday that more than 43,530 participants have participated in the Phase 3 trial, and 38,955 volunteers have received the second dose.
The two vaccines are different. Pfizer is based on a messenger RNA platform, a vaccine technology that has never been approved, while RDIF is based on an inactivated adenovirus vector. Scientists say that one of the advantages of adenovirus vaccines is that they do not need to be stored and transported at extremely low temperatures.
But Hotez cautioned that regardless of the composition of the vaccine, it is possible for the drugmaker to make a statement of efficacy at this time, thereby surpassing itself.
“I would say that no announcement should be made. This is not something we are going to do. The way we do this is to submit the document to the regulator. The regulator authorizes, approves, or approves it. Then, you go on and you This information can be publicly released along with the upcoming clinical trial data.”
Martin McKee, a professor of European public health at the London School of Hygiene and Tropical Medicine, told CNN that Pfizer initially only planned to conduct an interim analysis of 32 positive cases, but the FDA said this was not enough.
McGee agreed that in the Sputnik V case, 20 positive cases were a weak basis for analysis, but despite this, he expressed “cautiously optimistic” about the Russian announcement. He said it all depends on how many people are included in the trial and the infection rate in the community where the trial is located.
RDIF said that as part of the Phase 3 trial, more than 20,000 people have received the first dose of Sputnik V vaccine, and 16,000 participants have received the second dose.
“I think [RDIF] Knowing that they must review this, and they stated in the press release that they will publish a leading international journal. Therefore, they will have to do this, and without a fairly strict data review, these journals will not accept anything. They know this very well, and they don’t have to make any mistakes. “
RDIF told CNN that Russia will release the Sputnik V clinical trial protocol in November, and the next interim analysis will target 39 coronavirus cases.
Russia announced the world’s first approved coronavirus vaccine earlier this year, and it drew criticism from the scientific community in August—even before the key Phase III trials were completed.
In September, “The Lancet” published the first human test results of Sputnik V. The first two trials only involved 76 people, so it is impossible to determine whether the Russian vaccine is safe and effective. However, the peer-reviewed report stated that only minor adverse reactions were reported, and the vaccine triggered an immune response among trial participants.
Eleanor Riley, professor of immunology and infectious disease at the University of Edinburgh, urges all vaccine manufacturers to put quality and safety first.
In a statement to the British Science Media Centre, she said that RDIF’s announcement of an interim analysis of Sputnik V was “encouraging”. However, she added: “I worry that these data will be driven out after Pfizer/BioNtech announced earlier this week.”
She also said: “This is not competition.” This has attracted the attention of many people in the scientific community.
“We need to conduct all trials in accordance with the highest possible standards. It is especially important to comply with pre-set standards that obscure the test data so as not to pick up the data. Any test lower than this standard may cause the public to lose trust in Of all the vaccines, that would be a disaster.”