As expected, the FDA has expanded emergency use authorization (EUA) for Pfizer Inc. and Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), to include adolescents 12 through 15 years of age, marking what Acting FDA Commissioner Janet Woodcock called "a significant step in the fight against the COVID-19 pandemic."
The rocky first quarter for public biopharmaceutical companies continued into April as the BioWorld Biopharmaceutical index remained flat for the period in contrast to the general market, with the Dow Jones Industrial Average growing by more than 2%. Weighing on the sector has been softer than expected earnings in the period among the top tier companies.
LONDON – A single dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine does not promote a strong enough immune response to provide protection against variants of SARS-CoV-2, including the Kent variant B.1.1.7, which as of April 29 had caused 226,635 confirmed infections in the U.K.
LONDON – The latest tranche of data from an array of large-scale COVID-19 studies running in the U.K. provides real-world evidence that vaccines have a dramatic effect in preventing hospitalization and death, but that there are a very small number of vaccine failures. The data cover 3,842 people who received a vaccine and subsequently were admitted to the hospital between Dec. 8, 2020, when the national vaccination rollout began, and the data cutoff of April 10, 2021.
LONDON – A large scale U.K. study looking at the impact of COVID-19 vaccinations on antibody responses and new infections in 373,402 people in the general population has shown a single dose of vaccine cut infections by 65%.
LONDON – A large scale U.K. study looking at the impact of COVID-19 vaccinations on antibody responses and new infections in 373,402 people in the general population has shown a single dose of vaccine cut infections by 65%. Symptomatic infections fell by 74% and infections with no reported symptoms by 57%, 21 days after receiving the first dose of either Astrazeneca plc’s or Pfizer Inc./Biontech SE’s vaccine.
LONDON – The EMA’s safety committee has concluded that unusual blood clots with low blood platelets are a rare side effect of Johnson & Johnson Inc.’s COVID-19 vaccine and that a warning should be added to the label. The decision is based on all available evidence, which currently consists of eight reports from the U.S. of serious cases of thrombosis, one of which was fatal. All cases were in people under 60 years of age, and within three weeks after vaccination, the majority in women. One case occurred during the clinical trials.
As COVID-19 deaths across the globe top 3 million, with more than 1 million in Europe alone, the global demand is increasing for mRNA vaccines, even as sponsors of adenovirus vaccines push back against ongoing safety concerns. Last week, the World Health Organization’s (WHO) Regional Office for Europe reported that the confirmed COVID-19 death toll for the region had surpassed 1 million, with 1.6 million new cases being reported every week. More than 171 million doses of COVID-19 vaccines have been administered in the region, translating to nearly 13% of the European population receiving one dose and close to 6% completing both doses of the vaccines.
The current pause on administering Johnson & Johnson’s (J&J) one-dose COVID-19 vaccine likely will continue in the U.S. after the CDC’s Advisory Committee on Immunization Practices (ACIP) declined to make a recommendation on a path forward April 14.
LONDON – The U.K. is moving on to the next phase of testing mixed dosing schedules for COVID-19 vaccines, launching a study in which it will assess the effect of using Moderna Inc. or Novavax Inc.’s products as the second dose in a heterologous prime boost trial.