Vaccine maker Moderna Inc will soon request real-time reviews of its experimental COVID-19 vaccine in Europe, days after the EU health regulator released ongoing reviews of its rivals’ injections. The drug developer said it was in talks with European countries and would send the same data it plans to send to the US Food and Drug Administration for authorization.
The European Medicines Agency earlier this week released real-time reviews of the COVID-19 vaccines being developed by US drugmaker Pfizer and Germany’s BioNTech, following a similar announcement for AstraZeneca.
Real-time reviews could speed up the approval process for a successful vaccine, by allowing researchers to submit findings in real time, without waiting for studies to complete.
A continuous review is one of the regulatory tools used by the European Medicines Agency to accelerate the evaluation of a promising medicine or vaccine during a public health emergency. Normally, all data on the efficacy, safety and quality of a medicine and all required documents must be submitted at the beginning of the evaluation in a formal application for marketing authorization. In the case of ongoing review, EMA’s Committee for Human Medicines (CHMP) reviews data as it becomes available from ongoing studies, before a formal application is submitted.
Once the CHMP decides that sufficient data is available, the company must submit the formal application. By reviewing the data as it becomes available, the CHMP can give its opinion earlier on whether the medicine or the vaccine should be authorized or not.
Moderna Inc. also said it would not enforce its patents related to Covid-19 vaccines during the pandemic, in an effort not to dissuade other companies and researchers from making similar injections.
“As long as the pandemic continues, Moderna will not enforce our Covid-19-related patents against those who make vaccines intended to combat the pandemic,” the company said in a statement Thursday. (With contributions from the Agency)
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