On Wednesday, Canada became the third country in the world to grant approval for Pfizer and BioNTech’s covid-19 vaccine. The decision comes just as the U.S. Food and Drug Administration is expected to make its own call this week, following a meeting of independent experts on Thursday who will recommend whether or not an emergency use authorization should be granted for the messenger RNA-based vaccine.
According to Health Canada—the country’s regulatory equivalent of the FDA—Pfizer and BioNTech submitted for approval of their vaccine in early October, based on studies involving about 44,000 participants. In those who received the two-dose vaccine, it appeared to be 95 percent effective at preventing symptoms from the viral illness a week after the second dose. Its possible side effects include injection site pain, fatigue, fever, and headache.
“[A]fter a thorough, independent review of the evidence, Health Canada has determined that the Pfizer-BioNTech vaccine meets the Department’s stringent safety, efficacy and quality requirements for use in Canada,” the agency said in its announcement. The vaccine will be approved for people ages 16 and above, though ongoing research by Pfizer/BioNtech is now studying younger children.
Canada is now the third country to approve the Pfizer/BioNTech vaccine. The UK was the first to grant an emergency approval last Monday, while the small island nation of Bahrain approved it on December 4. Both the European Union and other countries are now conducting their own reviews of this candidate, as well as the similar mRNA vaccine developed by Moderna. Still other vaccines are in development and reaching the final stages of clinical research (these vaccines may hold advantages in the upfront costs it will take to mass-produce or store doses, an important consideration for less-wealthy countries).
Meanwhile, the FDA will hold an advisory committee meeting tomorrow—a step usually taken before any major drug or vaccine approval. The committee will evaluate the trial results and safety data collected by the companies and offer their recommendation for an emergency use authorization of the vaccine. There will also be a committee meeting about the Moderna vaccine on December 17.
It’s widely expected that these vaccines will receive the go-ahead from the FDA. Just today, the Wall Street Journal reported that the head of the advisory panel—University of Michigan researcher Arnold Munro—predicted that the “likelihood of approval is high,” for Pfizer/BioNTech’s vaccine. The FDA, in its review of the trial data released Tuesday, stated that there were no “specific safety concerns identified that would preclude issuance of an EUA.” Many states, including New York, are already planning to receive vaccine doses by the end of the week.
Here’s hoping everything goes off without a hitch.