Pfizer vaccine cleared in US, landmark in Covid-19 fight

Bloomberg

Pfizer Inc gained emergency US authorisation for its Covid-19 vaccine, completing an unprecedented scientific sprint that could eventually help bring an end to a pandemic that has killed nearly 300,000 Americans.
The Food and Drug Administration’s (FDA) decision to authorise use of Pfizer and partner BioNTech SE’s vaccine will
now set in motion a complicated immunisation drive that will launch across the country in coming days. Among the first to be inoculated will be healthcare workers and seniors living in long-term care facilities.
“With science guiding our decision-making, the available safety and effectiveness data support the authorisation of the Pfizer-BioNTech Covid-19 vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks,” Peter Marks, the head of the FDA’s office that oversees vaccines, said.
The approval also caps a fraught political struggle that has seen President Donald Trump push drug regulators to swiftly clear a vaccine. In the final hours of the review, White House Chief of Staff Mark Meadows suggested to FDA Commissioner Stephen Hahn that failure to clear the vaccine for use soon could cost him his job.
The Pfizer-BioNTech shot is a landmark scientific achievement, a vaccine built from a breakthrough technology in a matter of months, in the face of a pandemic that has sickened millions worldwide. It has already been cleared by regulators in the UK, Canada and other countries.
“We have worked tirelessly to make the impossible possible, steadfast in our belief that science will win,” Pfizer Chief Executive Officer Albert Bourla said in a statement. “As a US company, the news brings great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to help bring an end to this devastating pandemic.”
The first doses will begin shipping throughout the country immediately, Bourla said in a video message released following the emergency-use authorisation. Trump called it “one of the greatest scientific accomplishments in history” in a video on Twitter, saying the vaccine will save millions of lives and end the pandemic.
A shot similar to Pfizer and BioNTech’s made by Moderna Inc is expected to gain US clearance next week, providing the country with a potent combination for beating back the pathogen. More vaccines are also expected to be brought to market next year, expanding the arsenal doctors will have to rein in Covid-19.
Pfizer’s vaccine, like Moderna’s, uses a new technology called messenger RNA that turns the body’s own cells into vaccine-producing factories to fight the coronavirus. In a trial of almost 44,000 people, it was 95% effective at preventing symptomatic cases of Covid-19, protecting people of all ages
and ethnicities. Crucially, it was able to prevent the most severe infections.
Pfizer and BioNTech plan to provide clinical trial participants who received the placebo the authorised shot “at scheduled timepoints in the study,” the companies said in a joint-release, without elaborating on when those timepoints would be. “The vaccine option will be voluntary and will be implemented in alignment with the regulatory authorities where the trial is conducted.”
Following a vote by an advisory panel of outside experts backing the vaccine for use in people 16 and older, the FDA was weighing how to address reports of serious allergic reactions in the UK, where the vaccine was approved earlier this month. Officials there have since told people with a history of significant allergic reactions not to get the vaccine.
In a fact sheet for patients, the FDA said “there is a remote chance” the vaccine could cause a severe allergic reaction and told doctors in a similar document they should have medical interventions on hand to help treat such a side effect.