Regulators explore new methods to evaluate vaccines for latecomers
A cross-border coalition of medicines regulators has begun exploring alternatives to large-scale clinical trials in evaluating the efficacy and safety of coronavirus vaccines, as it is becoming difficult for latecomers to secure enough study participants.
If the International Coalition of Medicines Regulatory Authorities finds other effective ways, drugmakers in Japan and other countries trailing the United States and European countries in COVID-19 vaccine development would be able to accelerate their development and production.
The authorization or approval of vaccines generally requires a large-scale clinical study with the involvement of tens of thousands of participants in groups receiving a vaccine or a placebo to assess its safety and efficacy by comparing their data.
Apr 6, 2021 7:45am Novavax articulated its crossover plans alongside an update on the testing of its NVX-CoV2373 vaccine in children. (Novavax)
Novavax has added crossover arms to late-phase clinical trials of its COVID-19 vaccine. The action will enable participants in the placebo cohorts of the original trials to get vaccinated without unblinding the studies.
Participants in the 15,000-subject U.K. trial and 30,000-subject U.S.-Mexico study, which is yet to post data, will be offered the chance to get an additional round of injections. People who originally got a placebo will get two doses of the vaccine, and people who originally got the vaccine will receive two doses of placebo.
Health by Emma Reynolds  A heath chief from the European Medicines Agency (EMA) has said that there is a link between AstraZeneca s COVID-19 vaccine and blood clots. In my opinion, we can say it now, it is clear there is a link with the vaccine, said the EMA s head of vaccines Marco Cavaleri in an interview with Italy s Il Messaggero newspaper. Mr Cavaleri indicated that the EMA would confirm this view, adding, in the next few hours, we will say that there is a connection, but we still have to understand how this happens . He said that we still do not know what causes this reaction , as reports accumulate of people across the world experiencing blood clots after receiving the jab developed by British-Swedish drug company AstraZeneca and Oxford University.
 A heath chief from the European Medicines Agency (EMA) has said that there is a link between AstraZeneca s COVID-19 vaccine and blood clots. In my opinion, we can say it now, it is clear there is a link with the vaccine, said the EMA s head of vaccines Marco Cavaleri in an interview with Italy s Il Messaggero newspaper. Mr Cavaleri indicated that the EMA would confirm this view, adding, in the next few hours, we will say that there is a connection, but we still have to understand how this happens . He said that we still do not know what causes this reaction , as reports accumulate of people across the world experiencing blood clots after receiving the jab developed by British-Swedish drug company AstraZeneca and Oxford University.
Link between jab and clots now clear | Sunshine Coast Daily sunshinecoastdaily.com.au - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from sunshinecoastdaily.com.au Daily Mail and Mail on Sunday newspapers.