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Tuesday, May 17, 2022

US grants Pfizer Covid vaccine full approval

The US Food and Drug Administration on Monday fully approved Pfizer’s Covid-19 vaccine, a move expected to trigger a new wave of vaccine mandates as the Delta variant batters the country.

“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 recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.”

The Covid vaccine, which may now be marketed under its brand name Comirnaty, is the first to receive full approval. 

Tens of millions of shots have already been administered under an emergency use authorization (EUA) that was granted on December 11, 2020.

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.

Impact on Costa Rica

This change in authorization does not have an immediate or direct effect on Costa Rica. However, the Health Ministry does rely on the FDA, the European Medicines Agency, the World Health Organization, and other international regulatory agencies to shape its own policies.

The Pfizer and AstraZeneca vaccines have been authorized for emergency use in Costa Rica. If Costa Rica homologates the FDA’s full approval, it could result in more widespread access to the jab, including in the private sector.

Vaccine mandates in the United States could also impact airline travel policies. Canada has already said it will require vaccination for air travel.

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