The European Medicines Agency (EMA) has issued new guidance outlining requirements for drug manufacturers that modify their COVID-19 vaccines to protect against several emerging variants to SARS-CoV-2. Read More

The FDA has approved Pfizer’s and BioNtech’s request for a revised Emergency Use Authorization (EUA) permitting their COVID-19 vaccine to be stored at normal pharmaceutical freezer temperatures. Read More

Despite facing significant delays in supplying the European Union with its ordered AstraZeneca (AZ)/Oxford COVID-19 vaccine doses, AZ has said that it is using a large number of doses made via its international supply chain to meet its second-quarter supply commitments with Europe. Read More

The Pfizer/BioNTech COVID-19 vaccine showed the same effectiveness for all age groups — including individuals over age 60 — confirmed a new study from Israel that included almost 1.2 million individuals. Read More

Significantly more hospitalized COVID-19 patients aged 70 and up were alive and free of respiratory failure after treatment with GlaxoSmithKline’s (GSK) investigational monoclonal antibody otilimab in a phase 2 clinical trial, the company said Thursday. Read More

Pfizer and BioNTech have begun assessing the safety and immunogenicity of a third dose of their COVID-19 vaccine against the coronavirus’ South African mutation and other potential viral variants. Read More

Ghana is the first country outside of India to get the COVID-19 vaccine from COVAX, the World Health Organization’s (WHO) eight-month-old vaccine-sharing program. Read More

Sinopharm, a unit of China National Pharmaceutical Group, and Chinese company CanSino Biologics have applied for public use of their COVID-19 vaccines in China. If approved, China would have four approved vaccines that were developed domestically. Read More

President Biden signed an executive order Wednesday mandating a review of the U.S. supply chain for critical goods, including materials needed for manufacturing COVID-19 products — fulfilling a promise he made on the campaign trail. Read More

The FDA has published a briefing document ahead of Friday’s advisory panel meeting showing that agency staff have found the promising, single-shot Johnson & Johnson COVID-19 vaccine safe and effective enough for Emergency Use Authorization (EUA). Read More

The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) will soon begin a phase 1 clinical trial of Moderna’s variant-specific COVID-19 vaccine candidate, mRNA-1273.351, which has been tailored to better protect against the virus’ South African mutation. Moderna will also conduct trials of its own. Read More

The World Health Organization (WHO) this week announced a vaccine injury compensation plan for the 92 low- and middle-income countries that are getting COVID-19 vaccines through its COVAX initiative. Read More