Trials of Russian COVID-19 Vaccine Start in Venezuela, President Maduro Says


Scientists have refused to disclose the results of the trials, but claim the vaccine was safe and produced an immune response that could provide six months of protection.

How will we know if the vaccine works?

Two injections of BBIBP-CorV at three different doses generated antibodies in all recipients of each group, including older participants, although the data does not prove the vaccine is efficacious, researchers at the CNBG subsidiary, Chinese disease control authorities and other research institutes said in the paper.

An advanced study involving tens of thousands of volunteers that is necessary to establish safety and effectiveness of the vaccine is scheduled to start in November or December.

The timeline now allows for a possible United States authorization of a coronavirus vaccine this year, a key step in controlling the COVID-19 pandemic, which has killed more than a million people and ravaged the global economy. If the vaccine is looking significantly better than the placebo, the companies can apply for emergency use, and the study may be halted or continue to its intended conclusion.

Regulators will review the vaccines after the companies have enough data to submit applications seeking an EUA or formal approval. "If earlier, it is better", Maduro said.

Health officials told a press conference last month that the country expects to be able to produce 610 million vaccine doses annually by year-end, stressing it would be affordable.

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Russian Federation claimed at the time that it had registered the first effective coronavirus vaccine, but was criticsed both at home and overseas for doing so before full testing had been carried out.

The move by China National Biotec Group Co (CNBG) is aimed at boosting public confidence in homegrown inoculations, the Journal reported, citing a company website and some students who applied for it.

Pfizer/BioNTech said it may have data as early as October and Moderna says it could have similar evidence in November.

Pfizer Inc. said it could seek emergency-use authorization for its Covid-19 vaccine in the late November if the shot is shown to be effective in a large late-stage trial, putting to rest any notion that a vaccine could be cleared for emergency use in the USA before Election Day.

The FDA must make sure that the benefits of a vaccine outweigh the risks before authorization since they are meant to be given to hundreds of millions of healthy people. "The plan includes strategies to ensure these groups are successfully vaccinated", according to a news release by the Maine Department of Health and Human Services.

Pfizer said that it would likely seek emergency approval for a COVID-19 vaccine in late November, citing recent federal guidance that toughened approval standards for a vaccine, despite President Trump's efforts to push for a shot by the "special day" of Nov. 3.