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.
For almost two months, Brazil’s health care surveillance agency Anvisa, the European Medicines Agency, and the Directorate-General for Health and Food Safety have been sharing regulatory and confidential information as part of an effort to improve the safety and efficacy of drugs and medical devices.
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.
LONDON – Initial results from the U.K. randomized trial assessing mixed COVID-19 vaccine schedules show there is a significant increase in systemic side effects with one dose of Astrazeneca plc’s and one of Pfizer Inc./Biontech SE’s vaccines (in either order), compared to receiving two doses of the same vaccine.
Building on existing guidance and nearly eight years’ experience with biosimilar monoclonal antibodies and fusion proteins, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a final guidance detailing a streamlined approach to licensing biosimilars.
LONDON – The SARS-CoV-2 variant first detected in India last year has joined those from the U.K., South Africa and Brazil as a “variant of global concern,” the World Health Organization said on May 10.
LONDON – Abingworth announced the final closing of its latest fund at $582 million, bringing the amount committed to the London-based venture capital firm in 2021 to more than $1 billion. The clinical co-development fund 2 will finance and manage late-stage development of phase III programs sourced from pharma and biotech companies, receiving a pre-negotiated fee when a drug is approved. The model obviously has appeal, with the new fund being significantly oversubscribed and exceeding its target of $350 million.
The European Commission posted a draft legislative framework for regulation of artificial intelligence, a document that spans all potential uses of such algorithms rather than just medical ones.
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.
In a first for the biotech industry, the European Commission (EC) has imposed a €7.5 million (US$9.05 million) fine on Sigma-Aldrich, under the EU’s 2004 Merger Regulation, for providing incorrect or misleading information during a merger investigation.
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