Coronavirus: Europe raised issues about efficacy and safety of Pfizer-BioNTech vaccine in November
- Concerns involved ‘unexpectedly low quantities of intact mRNA in vaccines developed for commercial production’, according to The BMJ
- Pfizer says the European Medicines Agency approval of the vaccine on December 21 meant any questions during the review process had been answered
Europe’s drug regulator was worried about the efficacy and safety of the Pfizer-BioNTech vaccine early in the treatment’s review, according to a new article in The BMJ, a British medical journal.
The article cites classified information from the European Medicines Agency (EMA), which reviewed the Pfizer-BioNTech Covid-19 vaccine for distribution within the European Union. EMA officials specifically expressed concerns about differences between the clinical and commercial batches of the vaccine.
“Regulators had major concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production,” the peer-reviewed article found.
The disclosure comes as a long list of pandemic-hit countries are receiving the first mass deployment of mRNA vaccines, a novel technology that pharmaceutical companies have invested heavily in throughout the past decade. Some corners of the internet have swirled with false claims that these vaccines alter human DNA and are toxic.
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Messenger RNA (mRNA) is a single-strand molecule of RNA, short for ribonucleic acid. While traditional vaccines create immunity from a virus by inserting a human with a small quantity of the inactivated pathogen, mRNA vaccines bypass this step by directly “instructing” human cells how to make a viral or bacterial protein, which then allows the body to develop immunity.