Fifteen scientists from five countries signed the letter presenting their concerns to the international medical journal, Enrico Bucci, an associate professor biologist at Temple University in Philadelphia, told Reuters.
Reuters did not see the content of the letter. Nonetheless, the move highlights growing concern among scientists about the safety and efficacy of the Sputnik-V vaccine, the use of which was approved by the government before the completion of full human trials.
The official letter came days after a larger group of scientists, including 15, signed an open letter to the editor of The Lancet, posted on Bucci’s personal blog, after the journal published the results of the stage trial. initial of the Gamaleya Institute in Moscow.
They said they found patterns in the Phase I / II data, which were peer-reviewed in the journal, that seemed “very unlikely,” and that several participants reported identical antibody levels.
The Gamaleya Institute did not immediately respond to a request for comment on the formal letter sent Monday.
Last week, the institute rejected the criticism contained in the open letter, which was initially signed by 26 scientists but now has 38 signatories.
“The published results are authentic and accurate and were reviewed by five reviewers for The Lancet,” Denis Logunov, deputy director of the institute, said in a statement.
He said his institute sent the entire raw data set on the trial results to The Lancet.
The Lancet said it had invited the authors of the Russian vaccine study to respond to questions raised in Bucci’s open letter.
“We are closely monitoring the situation,” he added.
Alexey Kuznetsov, Russia’s deputy health minister, told the Interfax news agency on September 10 that the Gamaleya Institute had already sent detailed responses to the Lancet editor.
Bucci said the blog posted last week had attracted broad international support.
“We started with a dozen of us and now we have reached triple the number of signatures, with colleagues from the United States, Switzerland, Australia, India, Russia, Great Britain, Japan, Germany, Canada,” Bucci said.
He said the formal letter to The Lancet was signed by only 15 scientists with expertise in virology, immunology, pharmaceutical development, integrity of research, and statistical analysis. Most were Italians, but they also included scientists from Sweden, Great Britain, the United States and Japan, he added.
“The editor of the magazine wrote asking us to send him our objection points and inviting the authors of the Russian vaccine study to respond to our points,” Bucci said.
Naor Bar-Zeev, deputy director of the John Hopkins Bloomberg School of Public Health, who reviewed the Russian data last week, defended his analysis of the research following the blog post.
“The results are plausible and not very different from those seen with other AdV vector products,” he said.
The researchers had provided more detail than was necessary for the review and answered their questions “intelligently, practically and safely but discreetly.”
The results of the Russian phase I / II trials, involving 76 participants and carried out in June-July, were published in The Lancet on September 4. the authors said.
A phase III trial was launched on August 26, with 40,000 participants. About 31,000 people have already signed up to participate, Health Minister Mikhail Murashko said.
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