New research shows Pfizer/BioNTech's vaccine is effective against the B.1.1.7. variant of coronavirus disease 2019 (COVID-19); Amazon offers to aid vaccine distribution; FDA issues drug safety labeling changes for Enhertu.
New research from Pfizer and BioNTech indicates the companies’ vaccine against coronavirus disease 2019 (COVID-19) works just as well against a highly transmissible COVID-19 variant, B.1.1.7., first discovered in the United Kingdom, STAT News reports. The study, which has yet to be peer-reviewed, concluded the vaccine had equivalent neutralizing titers to both the B.1.1.7 variant and pseudoviruses bearing the Wuhan reference strain. Investigators continue to test vaccines against other concerning variants that have originated in South Africa and Brazil. If the virus picks up enough significant mutations impacting the vaccines’ efficacy, updated immunizations will likely be developed in weeks or months as opposed to years, experts said.
Amazon has sent a letter to President Joe Biden offering to assist in the new administration’s vaccine distribution plan, according to The Hill. The newly elected president has said he wishes to vaccinate 100 million Americans against COVID-19 in 100 days. Amazon’s CEO of consumer business, Dave Clark, said the company’s scale can allow it to make a meaningful immediate impact in the fight against COVID-19. The company already has an agreement with a licensed third-party occupational health care provider to provide on-site vaccines at its facilities around the country.
The FDA has issued new drug safety-labeling changes for trastuzumab deruxtecan (Enhertu), a treatment for unresectable or metastatic human epidermal receptor 2 (HER2)-positive breast cancer in patients who have received 2 or more prior anti-HER2-based regimens. Enhertu was approved by the FDA in December 2019 for HER2-positive breast cancer but also received an Orphan Drug Designation in May 2020 for the treatment of gastric cancer. The new warnings and precautions involve potential for interstitial lung disease/pneumonitis and left ventricular dysfunction among those taking the drug. The changes also includes updated adverse reactions and guidance on used in geriatric populations.
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