With the global COVID-19 pandemic and variants raising expectations about the need for booster shots, more companies are jumping into the vaccine space. But unless those sponsors have been engaging “in an ongoing manner” with the U.S. FDA on developing the manufacturing process and clinical trial program for their vaccine candidates, their emergency use authorization (EUA) requests may be denied, according to a new FDA guidance on EUAs for COVID-19 vaccines.
Two weeks after Pfizer Inc.-Biontech SE’s mRNA-based COVID-19 vaccine received emergency use authorization (EUA) for adolescents ages 12 to 15, the first in that age group, Moderna Inc.’s mRNA vaccine has hit the primary immunogenicity endpoint in its phase II/III study of participants ages 12 through 17.
LONDON – The U.K. is launching a trial to investigate the potential use of seven different COVID-19 vaccines as boosters, to provide safety and immunogenicity data for if/when immune responses to initial vaccination wane and a revaccination campaign is needed later in the year. The trial, at 18 sites across the country, will recruit 2,886 participants who previously received two doses of either Astrazeneca plc or Pfizer Inc./Biontech SE’s COVID-19 vaccines.
The top 100 public biopharmaceutical companies with market caps greater than $1 billion, and excluding big pharma companies, spent a total of almost $12 billion on R&D in the first quarter of 2021, compared to $9.4 billion invested last year.
LONDON – Delaying the second dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine significantly increases the antibody response in people ages 80 to 99, compared to the approved schedule of two doses three weeks apart, according to the latest data from the U.K. coronavirus immunology consortium.
It came as no surprise May 12 that the CDC’s Advisory Committee on Immunization Practices (ACIP) voted 14-0, with one recusal, to recommend the use of Pfizer Inc.-Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), in 12- to 15-year-olds following the FDA’s decision earlier this week to expand the vaccine’s emergency use authorization (EUA) to that age group.
In an open letter to Pfizer Inc. employees, the company’s CEO, Albert Bourla, provided some insight about why some countries don’t have COVID-19 vaccines and others have a surplus. It has nothing to do with intellectual property (IP), or even price, Bourla said.
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."
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.
