Paxlovid, a drug that was anointed as America’s silver bullet against COVID-19 by some health officials and even President Joe Biden, may not have any effectiveness for people that are already vaccinated according to new data revealed by Pfizer.
Pfizer’s Paxlovid has suffered another setback, with new data revealing that it provides little benefit to healthy, fully vaccinated, people (file photo)
The New York City-based pharma giant published its Phase 2/3 trial data analyzing the drug’s ability to prevent hospitalization or death depending on a person’s vaccination status and individual risk profile. It found that a fully vaccinated person with little personal risk had little to gain from using the drug.
Paxlovid is to be used by a Covid positive person to limit symptoms and prevent them from becoming serious enough to require intense medical care. Biden has propped it up as one of the keys to America’s Covid response, even offering it for free to anyone who tests positive for the virus – a move that had some detractors.
This is yet another setback for Pfizer and one of its main Covid products, as concerns have also been raised over some users having symptoms return after they complete a course of the drug.
The news comes as America’s Covid situation remains stable are 99,288 cases per day – a five percent drop over the past week – and 372 deaths per day.
President Biden (pictured) has been a proponent of Paxlovid, heralding it at his State of the Union address this year and making it the center of his ‘Test to Treat’ Covid response
Paxlovid received emergency use authorization from regulators in late 2021, and quickly became a favorite of the White House.
Biden touted its effectiveness at his 2020 State of the Union address earlier this year, heralding it for findings in clinical trials that it could reduce hospitalizations and deaths caused by the virus by 90 percent.
‘If you get COVID-19, the Pfizer pill reduces your chances of ending up in the hospital by 90 percent,’ Biden said.
‘I’ve ordered more pills than anyone in the world has. Pfizer is working overtime to get us a million pills this month and more than double that next month.’
He announced the ‘Test to Treat’ program, where Americans who tested positive for the virus at pharmacies around the country could quickly get a course of the drugs at no cost.
The federal government even began to roll out ‘Test to Treat’ centers around the country, with Rhode Island launching the nation’s first in late May.
Under this program, any American, no matter their vaccination status or risk profile, would be offered the drugs if they wanted them.
Data revealed last week by Pfizer shows that many of these people did not need the drugs at all. While Paxlovid is still very effective for the unvaccinated or people who are high risk for another reason, that pool is relatively limited.
According to most recent data from the Centers for Disease Control and Prevention (CDC), 90 percent of American adults have received at least one dose of the vaccine, and 77 percent are fully vaccinated.
Vaccine coverage is also near universal among older age groups that suffer the highest risk from Covid.
The recent data is yet another setback for Pfizer’s Paxlovid after all the fanfare that followed it during winter and spring.
Also last month, the CDC warned that some people who receive the drug may have their symptoms rebound afterwards.
‘Paxlovid continues to be recommended for early-stage treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease,’ the CDC wrote in the notice.
‘…A brief return of symptoms may be part of the natural history of SARS-CoV-2 (the virus that causes COVID-19) infection in some persons, independent of treatment with Paxlovid and regardless of vaccination status.’
Experts are not sure why this is occurring, or what could be causing a person that is seemingly fine to later start feeling sick against from the same infection.
The exact reason for this has not yet been determined, and there are no known examples of a person who had their symptoms rebound after completing courses of Paxlovid dying from the virus.
Health officials have been under fire recently for their approval of Covid vaccines for children aged six months old to five as well, another move that has been criticized for not providing much value.
Dr Vinay Prasad, an associate professor in the Department of Epidemiology and Biostatistics at the University of California, San Francisco, said that their was little evidence that the shots were needed in a YouTube video he uploaded Wednesday morning, and slammed officials and other media figures for not being ‘honest’ about the shots.
‘All your lying and exaggerating, its gonna be the same thing. The 20 percent [of parents] that wants to [vaccinate their children] will do it, and you’re not flipping any votes,’ he said.
‘You’re not persuading anybody. You’re laying it on a little thick and in the process you’re discrediting yourself’
He also had strong criticism for the data being used by mainstream media outlets like the New York Times in order to promote the vaccine.
Prasad points to a claim that the Moderna vaccine is 38 percent effective against the virus. He says that when data was adjusted by the firm to account for at-home testing – in which some cases do not get recorded properly – the effectiveness drops all the way to 27 percent.
He also said that there is little data available backing the claim that Pfizer’s vaccine is 80 percent effective at preventing infection.
‘We need to be honest about these,’ he said.
Dr Marty Makary, a public health expert from Johns Hopkins University, shared similar thoughts in an email to DailyMail.com, saying:
‘The studies were too small to achieve statistical significance when evaluating efficacy against mild or severe Covid-19 infection. As a result, the FDA allowed both companies to extrapolate effectiveness by measuring antibody levels, pointing to data from older children and adults.
‘They study had a confidence statistic so wide, you could drive an aircraft carrier through it. (They reported the largest confidence interval I have ever seen in my 20-year research career).’