The United States has approved the Pfizer/BioNTech Covid-19 vaccine on an emergency basis, with the first shots expected to be given this weekend, according to the Financial Times.
It says the decision by the Food and Drug Administration (FDA) has been one of the most politically fraught of the pandemic, which has claimed more than 280 000 lives in the US.
According to a Bloomberg report, the go-ahead will set in motion a complicated immunisation drive. Among the first to be inoculated will be healthcare workers and seniors living in long-term care facilities.
Peter Marks, head of the FDA’s office overseeing vaccines, said in a statement: ‘With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech Covid-19 vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks.’
The Bloomberg report says 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.
Said Pfizer chief executive officer Albert Bourla: ‘We have worked tirelessly to make the impossible possible, steadfast in our belief that science will win.’
A shot similar to Pfizer and BioNTech’s made by Moderna Inc is expected to gain US clearance in the coming week, providing the country with a potent combination for beating back the pathogen.
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.
According to Bloomberg, 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.
The report says that, in the face of many Americans have expressed scepticism about the vaccines being developed to fight the coronavirus, a wider campaign to convince the hesitant to get inoculated is expected in the weeks and months ahead.