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

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

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

Despite President Donald Trump's repeated promises of a vaccine before Election Day, scientists had been cautioning that it's unlikely data showing a leading shot actually works would come until November or December.

"So let me be clear, assuming positive data, Pfizer will apply for Emergency Use Authorization in the USA soon after the safety milestone is achieved in the third week of November", the company's chairman and CEO Albert Bourla said in an open letter. Topol recently had a virtual meeting with company executives to express his concerns and said he was frustrated they would not answer directly when he asked if they would seek broader use of a vaccine before November 3.

The possibility of further delays was raised after trials for two rival vaccines were put on hold in the United States this fall. Even if that were so, a pre-election vaccine would mean the Food and Drug Administration would have to give an nearly immediate thumbs-up.

USA health officials have sought to assuage those concerns out of fear that not enough Americans would take a vaccine early on.

Two American companies expect to apply for emergency approval for their Covid-19 vaccines by late November, welcome news as the United States hits a third surge of its coronavirus epidemic and approaches its eight millionth case.

"The preclinical results we report in this paper demonstrate the ability of MRT5500 to elicit a favorable immune response in both mice and non-human primates", Ronald Renaud, Chief Executive of Translate Bio, said.

Pfizer confirmed Friday it expects to seek emergency authorization of its experimental vaccine against Covid-19, if it is effective, in the third week of November. But he added in the letter that the new FDA safety standards would push the company to ask for emergency approval in late November. It has said that it may have interim data on its 30,000 person trial as soon as November.

This comes at a time when COVID-19 cases in the USA are climbing slightly, but the coronavirus deaths are relatively level this month.

The other candidate by CNBG also induced antibodies without causing serious side effects in early and mid-stage trials, a research paper showed in August.

In addition to safety and efficacy, the FDA will also examine Pfizer's manufacturing operations for the vaccine. "To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo".

"As far as I know, we already have a third vaccine in development", he added, which is now being tested at the Chumakov research centre of the Russian Academy of Sciences. Moderna shares were up slightly.