US FDA clears 4th dose of Pfizer COVID-19 for Americans 50+

U.S. regulators have authorized a fourth dose of Pfizer-BioNTech’s COVID-19 vaccine for Americans 50 and older due to concerns about waning immunity in that age group, drugmakers said Tuesday. .

The U.S. Food and Drug Administration has also authorized this supplemental vaccine booster for people age 12 and older with compromised immune systems.

The new boosters should be given at least four months after the third dose and are intended to provide better protection against serious illness and hospitalization, the companies said.

The clearance comes as some scientists have raised concerns about the highly contagious BA.2 Omicron subvariant, which has led to new spikes in COVID-19 cases in other countries.

COVID-19 cases in the United States have fallen sharply since a record increase in January, but have seen a slight increase over the past week, according to data from the United States Centers for Disease Control and Prevention.

“While this EUA (emergency use authorization) will help address a current need for some, we are working diligently to develop an updated vaccine that not only protects against current strains of COVID-19, but provides also more sustainable responses,” said Pfizer’s chief executive. Albert Bourla said in a statement.

Pfizer and BioNTech originally called for the next booster doses to be allowed for people 65 and older in a submission citing data collected in Israel, where a second booster is already allowed for many people over 18. The companies did not explain why the age range had been widened.

Debate over whether young, healthy people need a 4th vaccine

Scientists and officials have debated whether young, healthy people would need a fourth vaccine. A study of Israeli health workers suggested that the fourth dose added little additional protection in the age group.

Biden administration officials have said the U.S. government currently has enough vaccine doses to meet demand for another round of booster shots among older Americans, even as funding for the U.S. response to the pandemic is practically exhausted.

They say that unless Congress approves more spending, the government is unlikely to be able to pay for future inoculations, if they are needed, especially if vaccines have to be redesigned to target new variants.

Here in Canada, fourth doses are already offered to people in certain high-risk groups, such as residents of long-term care facilities or those who are immunocompromised.