Washington(AP): 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.
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 taking the company's drug along with another antiviral 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.
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, which has not yet been named, 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. (AP)
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Kolkata (PTI): The Congress on Tuesday staged a protest in front of Utkal Bhavan here against the killing of a migrant worker from Murshidabad district in Odisha, alleging a growing pattern of violence against Bengali-speaking workers across several states.
The demonstration was led by Congress leader Manoj Chakraborty, who said the latest incident in Odisha, where a young man from Murshidabad was allegedly beaten to death, reflected an alarming trend of harassment and attacks on Bengali migrant workers.
Chakraborty claimed that workers from West Bengal were being targeted and "tortured" in states such as Odisha, Delhi, Uttar Pradesh and Rajasthan, often merely for speaking the Bengali language.
"The workers are forced to leave their homes because there is no livelihood, no jobs, in their areas. When they go outside the state to earn a living, they are attacked for their identity," Chakraborty told reporters during the protest.
Demanding immediate government intervention, the Congress leader said the safety of migrant workers must be ensured through institutional measures. He urged the government to issue official identity cards to all migrant workers at the earliest.
"These identity cards should clearly mention the worker's home district, the local police station and the contact number of a police officer so that they can seek immediate help while working outside the state," he said.
The Congress leader said that such incidents would continue unless concrete steps were taken to protect migrant workers.
A 30-year-old migrant worker from West Bengal was allegedly killed in Odisha's Sambalpur district following an altercation over a bidi recently, police said.
Juel Sheikh was working, along with a few others from West Bengal, in the construction of a building in Shanti Nagar in the Ainthapalli police station area.
They were returning from work when a group of six men stopped them and asked for a bidi. An altercation broke out, leading to a scuffle between the two sides, police said.
Juel was thrashed severely, and he died while undergoing treatment at the Sambalpur hospital. The six accused persons have been arrested by the police.
West Bengal's ruling TMC claimed that Juel was beaten to death over suspicion that he was an illegal Bangladeshi immigrant.
