UNICEF to stockpile syringes for COVID-19 vaccination_china
Oct 21 2020
If its vaccine proves effective, safe and can be consistently manufactured, the company would apply for emergency use authorization in the third week of November, CEO Albert Bourla said in an open letter last week.
In July, Moderna started a 30,000-person study in the U.S.to test whether the vaccine safely protects people from symptomatic Covid-19 disease, and enrollment is almost complete.
Newsom said, "California, today, is launching now, more formally, a Scientific Safety Review, a workgroup of 11 individuals, experts in their field".
He said that Phase 3 clinical trials in Thailand may be skipped entirely, should good results be reported from Phases 1 and 2, as this phase requires a large number of volunteers, which is no longer practical as there is no widespread transmission of COVID-19 in the country.
Companies must also show their vaccines are at least 50 percent effective in preventing participants from contracting COVID-19 and have a set plan to follow volunteers for at least one more year. His comment comes amid growing optimism that Oxford University's COVID-19 vaccine candidate could become available in the United Kingdom before Christmas. Only 43% of Blacks said they'd get the vaccine as soon as it was ready compared to 59% of white respondents, according to the poll.
"(These studies) are enormously informative because we can do such very, very careful monitoring under controlled conditions", he added.
"We think that, by taking every precaution, we can really limit the infection and then we should be able to do it quite safely given the vast amount of experience we have in this field".
A vaccine is not likely to eradicate the virus, the advisor cautioned. Each person must receive two doses, three weeks apart.
Chris Chiu, an Imperial College scientist on the team, said the experiments would rapidly increase understanding of COVID-19 and the SARS-CoV2 virus that causes it, as well as accelerating development of potential new treatments and vaccines.
In light of increased pressure from the White House to have a vaccine by Election Day, coupled with rising safety concerns from the American public about a rushed approval process, the FDA in September issued additional guidance about vaccine trials.
While there is always a risk that the vaccine could be delayed only in California, Dr. Jeffrey Klausner, a professor of epidemiology at the UCLA Fielding School of Public Health, said Newsom named a renowned group that should be able to quickly make credible decisions.