US FDA allows pharmacists to prescribe Pfizer’s COVID-19 pill

Food and Drug Administration building is shown Thursday, Dec 10, 2020 in Silver Spring, Md. (MANUEL BALCE CENETA / AP)

BRUSSELS / ROME – The US Food and Drug Administration said on Wednesday it had authorized state-licensed pharmacists to prescribe Pfizer Inc's COVID-19 pill to eligible patients to help improve access to the treatment.

The antiviral drug, Paxlovid, has been cleared for use and available for free in the United States since December, but fewer than half of the nearly 4 million courses distributed to pharmacies by the government so far have been administered

The antiviral drug, Paxlovid, has been cleared for use and available for free in the United States since December, but fewer than half of the nearly 4 million courses distributed to pharmacies by the government so far have been administered.

Use of the pill, authorized to treat newly infected, at-risk people to prevent severe illness, has, however, jumped in recent weeks as infections rise.

"Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients," Patrizia Cavazzoni, director for the FDA's Center for Drug Evaluation and Research, said in a statement.

The agency said patients who tested positive for COVID-19 should bring their health records for the pharmacists to review for kidney and liver problems.

ALSO READ: Virus: Italy daily cases exceed 100k for the 1st time since Feb

The American Medical Association said in a statement prescribing decisions should be made by a doctor wherever possible.

"It (Paxlovid) is not for everyone and prescribing it requires knowledge of a patient's medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving," said AMA President Jack Resneck.

The FDA said pharmacists should refer the patients to a healthcare professional licensed to prescribe drugs if there is not sufficient information to assess kidney or liver function, or if modifications are needed due to a potential drug reaction.

Patients with reduced kidney function may need a lower dose of the treatment, the agency has said.

People in socially and economically disadvantaged regions are about half as likely to receive antiviral COVID-19 pills like Paxlovid than those in wealthier zip codes, a study by the US Centers for Disease Control and Prevention showed.

Medical staff work in the intensive care ward for COVID-19 patients at the CHR Citadelle hospital in Liege, Belgium, Oct 21, 2020. (FRANCISCO SECO / AP)

Belgium

A fourth dose of the COVID-19 vaccine will soon be administered in Belgium, the country's health ministers announced Wednesday at an inter-ministerial conference.

"As vaccination is and will remain the best protection, we will set up a new vaccination campaign in the autumn for all those over 50 and all adults who are ill or under treatment," Belgian Health Minister Frank Vandenbroucke announced on Wednesday.

The fourth or fifth dose for the immunocompromised will be given at least three months after the previous vaccination.

People over 50, people aged 65 to 80, and the immunocompromised will receive invitations to vaccinate first, starting in September.

A medical worker at work at a COVID-19 unit of the Sant'Orsola-Malpighi Hospital in Bologna, Italy, on Nov 12, 2020. (GIANNI SCHICCHI / XINHUA)

Italy

Italy's new COVID-19 cases surpassed 100,000 on Wednesday for the second consecutive day as the Omicron BA.5 subvariant continued to spread, data from the health ministry showed.

The ministry reported 107,786 new infections Wednesday, down from 132,274 reported on Tuesday and adding up to nearly 1.15 million active cases.

On Tuesday, the country's new daily infections surpassed the 100,000 mark for the first time since early February.

According to the latest data, the coronavirus transmission rate in Italy remains above 1.0, indicating that COVID-19 is in a phase of expansion.

Norway

Passengers boarding Norwegian Cruise Line Holdings ships won't have to take COVID-19 tests from next month unless required by local law, the U.S. cruise operator said on Wednesday as the crucial summer sailing season gathers steam.

Cruises setting sail from the United States, Canada or Greece's Piraeus will still require pre-cruise COVID-19 testing, and all of the company's guests aged 12 and above have to be fully vaccinated.