Pfizer says COVID-19 pill cut hospital, death risk by 90%
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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Cong indulging in anti-national activities, wants illegal immigrants to settle in Assam: PM
Namrup (PTI): Prime Minister Narendra Modi on Sunday launched a scathing attack on the Congress, accusing it of engaging in "anti-national" activities and helping illegal Bangladeshi immigrants to settle in Assam.
The PM, addressing a public rally after unveiling a Rs 10,601-crore fertiliser plant at Namrup in Assam's Dibrugarh district, accused the grand old party of opposing the revision of voter list due to its only aim of grabbing power.
"The Congress is indulging in anti-national activities. They want illegal Bangladeshi immigrants to settle in Assam's forests and land. They only want to strengthen their vote bank, and don't care about the people," he claimed.
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Modi said the opposition party is not concerned about the identity, existence and pride of Assamese people, which the BJP has been trying to protect.
"The Congress is opposing the revision of voter lists as it wants to grab power... They oppose whatever good I try to do... The BJP government will always work to protect the identity, land, pride and existence of Assamese people," Modi asserted.
"Assam must be safeguarded from the poison of Congress' appeasement and vote-bank politics. I assure you all that BJP will stand like a shield to protect Assam's identity and honour," he told thousands of people ahead of the assembly polls.
The Assembly polls to 126 constituencies are likely to take place in March-April next.
Underscoring that BJP governments at the Centre and state are for the poor, tribals, youth and women, Modi said it is working to end decades of violence in Assam and the Northeast.
"Our government has always kept Assam's identity and culture paramount, highlighting symbols of Assamese pride on every platform," he added.
Addressing the rally on the second and final day of his Assam tour, the PM alleged that the Congress has inflicted "so much wrongs" to this country that despite "correcting" those for the last 11 years, a lot of work still remained to bring everything on track.
"When our government awarded Dr Bhupen Hazarika the Bharat Ratna, the Congress openly opposed the decision. Its national president remarked that 'Modi nachne gane walon ko Bharat Ratna de raha hai' (Modi is giving Bharat Ratna to dancers-singers), which is an insult to both Bhupen Da and the people of Assam," Modi asserted.
He said the BJP government's aim is to make Assam as powerful as it was during the Ahom dynasty centuries ago.
"Industrialisation and connectivity are fulfilling Assam's dreams. The double-engine government of the BJP is empowering youth to see new dreams," he added.
Continuing its tirade against the Congress, Modi said even when a semiconductor unit was set up in the state, the opposition party went against it.
"It was the opposition government that for decades denied land rights to the tea community brothers and sisters, whereas the BJP government has given them land rights and a dignified life," he added.
Expressing satisfaction at the presence of a huge number of women at the rally, Modi said: "When my mothers and sisters come in such large numbers, it gives me a special feeling. Many sisters have come with tea gardens' flavour and tea's flavour creates a special feeling inside me."
He also informed the crowd that when Russian President Vladimir Putin visited India recently, Assam's black tea was gifted to the VIP.
"We facilitated the opening of Jan Dhan accounts for 7.5 lakh tea garden workers in Assam. Funds can now be transferred directly to their accounts, ensuring greater transparency and efficiency. The BJP government is also working to improve basic amenities in tea garden regions," the PM said.
Stating that India cannot develop without Northeast's progress, he said everyone is lauding Assam's development momentum nowadays.
"The benefits of development have reached the poor in far-flung areas of the country. Due to our relentless efforts, 25 crore people have been taken out of poverty and a neo-middle class has been created in India," Modi asserted.
The PM pointed out that fresh data has come which symbolises the changes taking place in the country.
"Earlier, among the poorest families in villages, only one in 10 had a bike. Now, nearly half the families in villages own a bike or a car. Mobile phones have reached almost every household and items like refrigerators, once considered a luxury, have now become common and found a place even in village kitchens," he said.
Modi said that the role of eastern and Northeastern India is continuously increasing, and the entire region will become the growth engine of the nation’s development.
"Namrup plant is a significant contribution of the Northeast to the country's fertiliser needs. Projects like this demonstrate that in the coming time, the region will emerge as a major centre of self-reliant India and will remain as Ashtalakshmi in true sense," Modi said.
