In a marked change in policy, the U.S. will send an estimated 4 million doses of AstraZeneca (AZ)/Oxford University’s COVID-19 vaccine to Canada and Mexico, according to a White House press briefing yesterday. Read More

Top U.S. health officials, including an FDA regulator testified on Capitol Hill this week that real-world evidence from people vaccinated against COVID-19 and data from ongoing trials will be used to decide how vaccines should be updated to handle variant strains. Read More

The European Medicines Agency (EMA) has concluded its evaluation of a small number of blood-clot cases in patients vaccinated with AstraZeneca’s (AZ) COVID-19 vaccine, finding the two-shot inoculation is still safe and effective, though it could be associated with low levels of blood platelets in very rare instances. Read More

Despite the unprecedented disruption and shift in priorities that COVID-19 brought to FDA’s Office of New Drugs (OND) in 2020, the office approved 53 novel drugs, published 31 new guidances and wrapped up the reorganization it had been working on since 2019, said Peter Stein, OND’s director, in the office’s annual report. Read More

The European Medicines Agency (EMA), which eased certain labeling requirements for COVID-19 vaccines in December, now says some of the same product labeling flexibilities may apply to COVID-19 therapeutics. Read More

New Jersey-based drugmaker Catalent has announced that it will significantly scale up manufacturing of the Johnson & Johnson (J&J) COVID-19 vaccine at its 300,000 square-foot facility in Anagni, Italy, which should help accelerate much-needed vaccine distribution in Europe. Read More

A letter to vaccination sites in the UK has cautioned that supplies of COVID-19 vaccines will be tight for about four weeks starting near the end of the month, but Pfizer has offered assurance that it is on track to meet its supply commitments on time. Read More

In another blow to AstraZeneca’s (AZ) COVID-19 vaccine, a peer-reviewed study has found that it failed to protect against mild-to-moderate infections caused by the virus’ South African variant. Read More

Medicago and GlaxoSmithKline (GSK) have launched a global phase 3 trial evaluating Medicago’s plant-derived COVID-19 vaccine candidate when combined with GSK’s pandemic adjuvant. Read More