• Pfizer and BioNTech submit data to the US FDA on safety and efficacy of their coronavirus vaccine in children ages 5-11 years; the companies plan to submit formal requests for a pediatric dose to regulators in the US, the EU and other countries in the coming weeks. Source
• In the US, coronavirus cases exceed 43 million. Source
• Sanofi announces that it is halting co-development of an unmodified mRNA coronavirus vaccine with Translate Bio (which it recently acquired for $3.2 billion), because the market is too crowded. despite promising results from Phase I and Phase II trials because the coronavirus vaccine market is too crowded. However, it is continuing co- development of a recombinant coronavirus vaccine with GlaxoSmithKline, which is currently in Phase III, and under study as a universal booster for coronavirus vaccines, regardless of their platform. Sanofi plans to use mRNA technology to develop vaccines for cancer, flu and other infectious diseases; it aims to bring a quadrivalent mRNA flu vaccine into the clinic in 2022. Source
• Japan’s Prime Minister, Yoshihide Suga, announces that the country’s state of emergency measures – which were implemented on 4 April – are ending, as new coronavirus cases decline, and its vaccine campaign has already reached almost 60 percent of the country’s population. Source
• In Romania, uptake of boosters, which recently became available to everyone, has been high, with 13,963 people receiving a third dose and 25,000 more scheduled for a booster. Nonetheless, Romania is home to the EU’s second-lowest vaccination rate; less than 34 percent of residents are fully vaccinated. The country’s daily coronavirus cases have reached an all-time high of 11,149 and, nationwide, only 26 of 1.336 ICU beds dedicated to COVID-19 patients remain. Source
• The US CDC reports that side effects from a third, booster dose of an mRNA coronavirus vaccine among 12,591 people were similar to those after the second dose; 79.4 percent reported local reactions after their third dose versus 77.6 percent after the second dose, and 74.1 percent reported systemic reactions after their third dose versus 75.6 percent after the second dose. The most frequent post-vaccine reactions were injection site pain (71 percent ), fatigue (56 percent), and headache (43.4 percent). Most of these reactions were mild (51.4 percent) or moderate (41.9 percent), with severe pain reported by 6.7 percent. Source
• The New York Times reports that Michelle Bolsanaro, the wife of Brazil’s unvaccinated president, received a coronavirus vaccine while she was accompanying her husband to the United Nations General Assembly in New York. Senator Omar Aziz, head of a parliamentary commission examining Mr. Bolsonaro’s handling of the pandemic, said, “I congratulate Mrs. Michelle, who, unlike her husband, was vaccinated, but someone should have told her that the vaccine applied in the United States is the same as in Brazil.”
• During their visit to New York four members of the Bolsonaro entourage (Pedro Duarte Guimaraes, the chief executive of Caixa Economica Federal, Brazil’s health minister, Marcelo Queiroga, Mr. Bolsonaro’s son Eduardo and a Brazilian diplomat) tested positive for COVID-19, although Mr. Guimaraes and Mr. Queiroga were fully vaccinated. Source
• Dr. Peter Marks, director of the F.D.A.’s Center for Biologics Evaluation and Research, has become active director of the FDA vaccines office, whose two outgoing leaders, Marion Gruber and Dr. Philip Krause, publicly questioned the need for coronavirus booster among the general population. Source