Moderna reveals detailed plans for COVID-19 clinical trial

Marco Green
September 19, 2020

"We have been working nine months to try to stop this virus by getting a vaccine to market", Bancel said in an interview.

If most of the people who got sick got the placebo shot, that would indicate the vaccine was protecting those inoculated and could be enough evidence to seek US regulatory approval for Emergency Use Authorization (EUA). The high-risk groups would include healthcare workers and older people.

Moderna has a vaccine supply deal in place with the US for 100 million doses, and has finished advanced talks with the European Union for the vaccine. The participants of the trial are expected to receive another shot of the adenovirus-based viral vector vaccine within 21 days of the first.

As of Thursday, Moderna had recruited 25,296 volunteers. But a recently published report in The Lancet claimed that patients involved in early trials of the COVID-19 vaccine developed antibodies with "no serious adverse events".

In late July, the USA government agreed to pay Sanofi and GSK up to $2.1 billion to speed up clinical development and manufacturing of the pair's candidate.

The Oxford University randomised control trial, being hosted by Wits University, was temporarily halted last week after a participant in the United Kingdom fell ill.

Countries across the world are racing to secure sufficient vaccines for their population. All three of the most likely initial vaccines are based on newer technologies, which means that the companies have had to create new manufacturing capacity, he said.

According to Russian Deputy Prime Minister Tatyana Golikova, Brazil, Venezuela, Azerbaijan, Kazakhstan, and Belarus are on the list of Russia's potential "partners" for vaccine development and production. The vaccine doses themselves will be bought by European Union countries.

FILE - The Pfizer company logo is photographed at Pfizer Inc. headquarters, in New York, Dec. 4, 2017.

Trump's Democratic rival, Joe Biden, said Wednesday though he's a fan of vaccines, he's not sure he would trust one approved before the November 3 election.

The documents described two unnamed vaccine candidates that must be stored at temperatures of minus 70 and minus 20 degrees Celsius. The requirements appear to be those from drug-makers Pfizer and Moderna.

"I don't trust Donald Trump", his rival from the Democratic party Joe Biden said Wednesday. He added "They're at this stage where they're actually making it because they feel very confident as to the results".

There will likely only be enough vaccines approved for every American who wants a shot by the second half of next year, according to Bancel.

MMA president Dr N. Ganabaskaran said the association believes even if Malaysia has its own bilateral negotiations for a vaccine, signing up for the Covax Vaccine Plan can be an added option that will guarantee access to vaccines for Covid-19.

Other reports by Click Lancashire

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