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U.S. Food and Drug Administration staff reviewers on Sunday said Pfizer-BioNTech’s COVID-19 vaccines were effective and safe for use in children aged 6 months to 4 years.

A look at some of the latest COVID-19 news includes the U.S. Food and Drug Administration’s plans to review changes to Novavax’s manufacturing process before the regulatory agency authorizes the company’s vaccine. Moderna expects to submit data to regulators soon with expectations of the company’s bivalent COVID-19 vaccine—consisting of the original Spikevax vaccine and a newer version, mRNA-1273.214 that contains an Omicron-specific vaccine—becoming available in late summer.

At the American Society of Clinical Oncology (ASCO)’s annual meeting this weekend, BioNTech and Dr. Vinod Balachandran, M.D. of Memorial Sloan Kettering Cancer Center, presented preliminary Phase I data of its BNT122, which it is evaluating with Genentech (Roche) in pancreatic cancer.

To bolster the increased demand for mRNA therapies, Germany’s Evonik Industries, in partnership with the U.S. government, is investing more than $200 million to build a lipid manufacturing facility in the United States.

Pfizer Inc. and partner BioNTech completed the filing with the U.S. drugs regulator seeking authorization for their COVID-19 vaccine in children under 5 years of age.

Pfizer Inc. will make all of the company’s patented medicines including the COVID-19 treatment Paxlovid and big-selling breast cancer drug Ibrance available at a not-for-profit price to 45 of the world’s poorest countries, the drugmaker said on Wednesday.

The Omicron variant of the coronavirus does not have a negative effect on cardiovascular health in young adults who have been vaccinated, a small study suggests. Additionally, women should not delay routine mammograms after receiving a COVID-19 mRNA vaccine, experts now say.

Drugmakers Pfizer Inc and BioNTech SE said on May 23 that three doses of their COVID-19 vaccine generated a strong immune response in children under age 5 and was safe and well-tolerated in their clinical trial.

The U.S. Food and Drug Administration set June 14-15 as the new meeting date to review Moderna Inc.’s emergency authorization request for the company’s COVID-19 vaccine for children aged 6 months to 5 years and Pfizer Inc.’s vaccine for those aged 6 months through 4 years.