This Feb. 5, 2021, file photo shows the Pfizer logo displayed at the company's headquarters in New York. Pfizer says its experimental pill for COVID-19 cut rates of hospitalization and death by nearly 90% among patients with mild-to-moderate infections. The company announced Friday, Nov. 5, it will soon ask the U.S. Food and Drug Administration and international regulators to authorize its pill, which is taken twice a day for five days. (AP Photo/Mark Lennihan, File)
Pfizer Inc. said Friday that its experimental antiviral pill for COVID-19 cut rates of hospitalization and death by nearly 90% in high-risk adults, as the drugmaker joins the race to bring the first easy-to-use medication against the coronavirus to the U.S. market.
Currently all COVID-19 treatments used in the U.S. require an IV or injection. Competitor Merck’s COVID-19 pill is already under review at the Food and Drug Administration after showing strong initial results, and on Thursday the United Kingdom became the first country to OK it.
Pfizer said it will ask the FDA and international regulators to authorize its pill as soon as possible, after independent experts recommended halting the company’s study based on the strength of its results. Once Pfizer applies, the FDA could make a decision within weeks or months. If authorized the company would sell the drug under the brand name Paxlovid.
Researchers worldwide have been racing to find a pill against COVID-19 that can be taken at home to ease symptoms, speed recovery and reduce the crushing burden on hospitals and doctors.
Pfizer released preliminary results Friday of its study of 775 adults. Patients who received the company's drug along with another antiviral shortly after showing COVID-19 symptoms had an 89% reduction in their combined rate of hospitalization or death after a month, compared to patients taking a dummy pill. Fewer than 1% of patients taking the drug needed to be hospitalized and no one died. In the comparison group, 7% were hospitalized and there were seven deaths.
"We were hoping that we had something extraordinary, but it’s rare that you see great drugs come through with almost 90% efficacy and 100% protection for death,” said Dr. Mikael Dolsten, Pfizer’s chief scientific officer, in an interview.
Study participants were unvaccinated, with mild-to-moderate COVID-19, and were considered high risk for hospitalization due to health problems like obesity, diabetes or heart disease. Treatment began within three to five days of initial symptoms, and lasted for five days. Patients who received the drug earlier showed slightly better results, underscoring the need for speedy testing and treatment.
Pfizer reported few details on side effects but said rates of problems were similar between the groups at about 20%.
An independent group of medical experts monitoring the trial recommended stopping it early, standard procedure when interim results show such a clear benefit. The data have not yet been published for outside review, the normal process for vetting new medical research.
Top U.S. health officials continue to stress that vaccination will remain the best way to protect against infection. But with tens of millions of adults still unvaccinated — and many more globally — effective, easy-to-use treatments will be critical to curbing future waves of infections.
The FDA has set a public meeting later this month to review Merck’s pill, known as molnupiravir. The company reported in September that its drug cut rates of hospitalization and death by 50%. Experts warn against comparing preliminary results because of differences in studies.
Although Merck's pill is further along in the U.S. regulatory process, Pfizer's drug could benefit from a safety profile that is more familiar to regulators with fewer red flags. While pregnant women were excluded from the Merck trial due to a potential risk of birth defects, Pfizer’s drug did not have any similar restrictions. The Merck drug works by interfering with the coronavirus' genetic code, a novel approach to disrupting the virus.
Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme which viruses need to multiply in the human body.
The drug was first identified during the SARS outbreak originating in Asia during 2003. Last year, company researchers decided to revive the medication and study it for COVID-19, given the similarities between the two coronaviruses.
The U.S. has approved one other antiviral drug for COVID-19, remdesivir, and authorized three antibody therapies that help the immune system fight the virus. But they have to be given by IV or injection at hospitals or clinics, and limited supplies were strained by the last surge of the delta variant.
Shares of Pfizer spiked more than 9% before the opening bell Friday.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
After months of investigation, board members from U.S. big oil companies were slated to appear before a House oversight committee this week to discuss their respective roles in pushing for climate initiatives internally. However, all four board members from Exxon, Shell, Chevron, and BP said they couldn't attend due to scheduling conflicts. Climate experts are testifying in their place about how effective big oil's climate promises have been so far. Meanwhile, President Joe Biden's lead science adviser Eric Lander has resigned after an investigation found he violated workplace policy. What will this mean for Biden's climate agenda? Amy Harder, executive editor of Cipher, a publication by Breakthrough Energy, joins Cheddar Climate to discuss.
Although this week's weather is predicted to be less severe than the 2021 storm, Texans are preparing for the worst - stocking up on supplies and emptying shelves in grocery stores, once again. Some Texans still have not recovered from last year's tragedy, and are heading into the next few weeks with anxiety for what's to come. Leslie Beyer, CEO of the Houston-based energy workforce & technology council, joins Cheddar News to discuss if the Texas grid will fail again.
The American Red Cross has declared its first-ever "national blood crisis" in the United States. Since COVID hit the U.S. in March 2020, blood donations have declined by 10 percent. American Red Cross Medical Director, Dr. Baia Lasky joined Cheddar News to discuss the country facing the worst blood shortage in over a decade. Dr. Lasky noted that as much as 40 percent of Americans are eligible to donate blood but only about 4 percent do so. "This is going to be ongoing," she said. "This is not an acute shortage. We really do need the commitment of people to come out and donate and donate again." Appointments to donate can be made by using the Red Cross Donor App, at RedCrossBlood.org, or calling 1-800-RED CROSS (1-800-733-2767).
Eight months after the National Football League announced $1 million in research into cannabinoids, the NFL-NFLPA Joint Pain Management Committee has awarded the funding to two teams of medical researchers at the University of California San Diego and the University of Regina. The NFL says the studies will investigate the effects of cannabinoids on pain management and neuroprotection from concussion in elite football players, respectively. Cheddar correspondent Chloe Ailello spoke with Jeff Miller, the executive vice president of communications, public affairs, and policy for the NFL, about the studies, as well as the recent lawsuit filed against the NFL by former Miami Dolphins head coach Brian Flores. "Maybe we can learn things from other alternative pain approaches that are going to benefit our player population and then sports medicine as a whole," Miller said.
On this episode of Cheddar Innovates: CEO of HereAfter AI discusses how artificial intelligence can be used to preserve family history and stories, and allow you to 'talk' to loved ones that have passed; Creator of the board game 'Travel Explore Discover' explains how she came up with the idea for this informative and educational board game, and how she's using the proceeds to give back to her community; Cheddar gets a look at Curiosity Stream's 'The Humboldt Current.'
Immunologist Dr. Purvi Parikh of the Allergy & Asthma Network joined Cheddar News to break down long Covid, in which Covid symptoms remain up to two years after infection; a phenomenon that has so far mystified health experts.
Solid-state battery maker Factorial Energy recently raised $200 million in a Series D round led by Mercedes-Benz and Stellantis. Factorial says the funding will be used to accelerate commercial production and deployment of its solid-state battery technology, which the company says is safer, and offers up to 50% more driving range than current lithium-ion technology. Factorial also has joint development agreements (announced in late 2021) with Mercedes-Benz, Stellantis, and Hyundai, three of the top 10 global automotive manufacturers, to commercialize its batteries. Factorial CEO Siyu Huang joined Cheddar News' Closing Bell to discuss.
David Malott, founder and chief architect at AI PlanetWorks joins Cheddar News to discuss the release of its augmented reality NFTs for the metaverse called 'TERA.'
A 2021 report from UK Research and Innovation found that the shipping industry makes up at least 2.5 percent of the world's total CO2 emissions. It's a problem that energy solutions company, Leclanché, is trying to solve. Founded in 1909, the company has been developing and producing batteries for more than 100 years. Today, Leclanché's lithium-ion battery is used to electrify not just ships, but also railroad locomotives, trucks, and specialty vehicles. Cheddar News spoke with Pierre Blanc, chief technology and industrial officer of Leclanché, to discuss.
