Pfizer’s COVID-19 antiviral treatment pill, Paxlovid, has shown evidence that it may not be beneficial for individuals who are vaccinated, according to the pharmaceutical company.
On Thursday, the company released the results of a new study on Paxlovid. Researchers analyzed 721 vaccinated adults with at least one risk factor for COVID and found that there was a “non-significant” risk reduction in hospitalization or death when treated with the antiviral pill.
However, experts assure the results maintain that the use of Paxlovid can significantly reduce severe symptoms of COVID for high-risk patients who have underlying health conditions.
“Paxlovid is something that is targeted towards high-risk individuals, so the fact that it doesn’t have a benefit to low-risk individuals isn’t surprising to me,” Dr. Amesh Adalja, infectious disease specialist at the Johns Hopkins University Center for Health Security, told ABC News.
“With up to 40-50% of people around the world estimated to be high risk, we believe there remains a significant unmet need for treatment options to help combat this disease, and we will continue to prioritize efforts to advance the development of Paxlovid,” Pfizer CEO Albert Bourla said in a release.
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The new data comes one week after the Food and Drug Administration revised the emergency use authorization for Paxlovid, allowing pharmacists across the United States to prescribe the COVID treatment to eligible patients.
Individuals who test positive for COVID and want to determine their eligibility to take Paxlovid can bring a list of their current medications and health records detailing kidney or liver problems to their pharmacist for review. Patients with reduced kidney function may require a lower dose of Paxlovid, per the FDA.
“The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,” said Dr. Patrizia Cavazzoni, director for the FDA’s Center for Drug Evaluation and Research, said in a release. “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 who are eligible to receive this drug for the treatment of COVID-19.”
Back in April, the Biden Administration announced plans for Paxlovid to be made “widely available,” Dr. Ashish Jha, White House Covid-19 Response Coordinator, said on Twitter.
“What are we working on? A lot more places where Pax will be available including more test-to-treat, education for providers to use it more regularly for eligible patients, and more,” Jha wrote at the time. “Paxlovid is extraordinarily effective at preventing bad outcomes. We’re getting it out to the American people.”
The Test to Treat initiative was launched earlier this year in order to give Americans easy access to COVID treatment, with “one-stop sites” to get tested for COVID-19 and then be prescribed with free oral antiviral medications.
The FDA first granted Paxlovid emergency use authorization in November 2021 for use in patients age 12 or older who are at a high risk of developing severe COVID-19 due to underlying medical conditions.
Each pack of Paxlovid contains 30 tablets taken over the course of five days. According to Yale Medicine, the pill is effective against the highly contagious COVID-19 omicron variant.
Yale Medicine infectious diseases specialist, Scott Roberts, believes the pill “shows clear benefit.”
“I think it is the beginning of a game-changer,” said Roberts. “It’s really our first efficacious oral antiviral pill for this virus. It shows clear benefit, and it really can prevent hospitalization and death in people who are at high risk.”