European regulator could OK 1st COVID-19 vaccine on Dec. 29

BERLIN (AP) — European regulators may approve a coronavirus vaccine developed by drugmakers Pfizer and BioNTech within four weeks, the EU’s drug agency said Tuesday, a time frame that could mean the shot is rolled out first in the United States and Britain.

The European Medicines Agency plans to convene a meeting by Dec. 29 to decide if there is enough safety and efficacy data about the vaccine for it to be approved, the regulator said. The agency also said it could decide as early as Jan. 12 whether to approve a rival vaccine shot by Moderna Inc.

German pharmaceutical company BioNTech and its U.S. partner Pfizer said earlier Tuesday that they had asked the European regulator for expedited approval of their vaccine. The companies have said that clinical trials showed the vaccine is 95% effective.

Multiple successful vaccines will be needed to end the pandemic, which has been on the upswing in Europe and the U.S. and so far left more than 1.4 million people worldwide dead. Pfizer and BioNTech have already sought approval to begin vaccinations in the U.S. in December. Rival Moderna said Monday it was asking U.S. and European regulators to allow the use of its vaccine.

British regulators also are assessing the Pfizer shot and another from AstraZeneca. There are several other vaccines in development, including in Russia and China.

Even after vaccines are approved, manufacturers and regulators will be monitoring how well they are received by patients to determine the frequency of rarer side effects that may only appear when millions are immunized. While the vaccines so far submitted for approval seem to prevent people from getting sick, it is still unclear whether they prevent people from picking up the virus entirely — and crucially — passing it to others.  ...