The EU's drug regulator would reportedly approve a COVID-19 vaccine even if it worked in less than 50% of people — a lower threshold than the FDA
European Union's drug regulator would approve a COVID-19 vaccineeven if it worked in less than half of people, the Wall Street Journal reported.
- In comparison, the US's drug regulator, the Food and Drug Administration (
FDA), expects a vaccine efficacy rate of at least 50%.
- The news suggests that the European Medicine Agency and the FDA could disagree on which vaccines to approve.
The European Union's drug regulator is reportedly willing to approve a
Officials at the European Medicine Agency (EMA) said that even if the efficacy rate of a vaccine was below 50%, they could give it the green light as long it was safe, per the Wall Street Journal.The FDA expects a vaccine shot to reach an efficacy rate of at least 50%.
Martin McKee, professor of European public
Several vaccines have made it into late-stage trials, including vaccines from AstraZeneca, Moderna, and Pfizer, but at different speeds in the US and Europe.AstraZeneca's clinical vaccine trials were paused in September after the drugmaker reported "suspected serious adverse reaction" in a participant in the UK. In the UK, the trials were only halted for a few days, whereas in the US the pause lasted for over a month, resuming only on Friday.
The news comes days after the FDA's panel of outside experts questioned the safety standards of the agency's COVID-19 vaccine approval at an advisory meeting.
The FDA requires a two-month follow-up after a final vaccine shot in trials before emergency approval. The experts said this is too little time, and were concerned about a vaccine later proving unsafe or ineffective.In more positive
- Admitad India drove sales worth Rs 17 crore during Diwali through Affiliate Marketing
- ‘Delhi Chalo’ march intensifies: Protesting farmers allowed to enter, will be escorted by the Delhi Police
- Uber, Ola hit a speed bump as Indian government caps surge pricing and issues new guidelines
- Farmers' protest: Delhi government denies permission to police to use stadiums as temporary jails
- Adani completes ₹1,300 crore acquisition of Alipurduar Transmission from Kalpataru Power