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US FDA grants Pfizer Covid-19 vaccine full approval

The widely-administered vaccine had already been approved under an emergency use authorisation.

Image: PA Images

THE US FOOD and Drug Administration has fully approved Pfizer’s Covid-19 vaccine for people aged 16 and older, a move which is expected to trigger a new wave of vaccine mandates as the Delta variant spreads throughout the US. 

The widely-administered vaccine had already been approved under an emergency use authorisation with experts and public health officials continuing to emphasise its safety and efficacy during that time. 

The Pfizer vaccine was officially approved for use in Europe by the European Medicines Agency (EMA) in December, paving the way for its rollout in Ireland. 

The EMA also issued a conditional marketing authorisation for the AstraZeneca vaccine in January and the one-shot Janssen vaccine in March. 

Today’s full approval from the FDA is expected to lead to an uptake in the Pfizer vaccine with US media reporting it will likely allow businesses and universities to require vaccinations. 

None of the three Covid vaccines authorised in the US had previously received full FDA approval.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic,” acting FDA Commissioner Janet Woodcock said in a statement.

“While millions of people have already safely received Covid-19 vaccines, we recognise that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.”

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The decision to award it approval was based on updated data from the drug’s clinical trial, including a longer duration of follow-up, with safety and effectiveness evaluated among more than 40,000 people.

The US military has previously announced it will mandate the vaccine as soon as it receives full approval, and a slew of private businesses and universities are expected to follow.

The vaccine remains available under emergency use authorization to children aged 12 to 15, but because it has now been fully approved, physicians may prescribe it to children under 12 if they believe it will be beneficial.

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AFP

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