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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Congress not just removed clothes at AI Summit but exposed its intellectual bankruptcy: PM Modi
New Delhi (PTI): Prime Minister Narendra Modi on Friday came down heavily on the Congress for the shirtless protest by its youth wing members at the AI Impact Summit recently, saying the opposition party can tear as many clothes as it wants, but his government will continue to work for the country's progress.
Addressing the News18 Rising Bharat Summit, Modi also said that the Congress did not just remove its clothes in front of foreign guests but also exposed its intellectual bankruptcy, asserting that the millennials have already taught the country's oldest party a lesson, and now Gen-Z is ready to do the same.
In an apparent jibe at Congress leader Rahul Gandhi, Modi said the opposition was unhappy seeing the statue of "Babbar Shers" (lions) installed atop the new Parliament building, but their own “Babbar Shers" were running away after facing the "shoes" of the general public.
Gandhi, the Leader of Opposition in the Lok Sabha, had said on February 24 that he was proud of the "Babbar Shers" of the Indian Youth Congress, who "fearlessly" raised their voice at the AI Summit.
"Congress ke Babbar Sher logon ki jute kha ke bhaag gaye (The 'lions' of Congress ran away after being hit by shoes by the public)," Modi said.
The prime minister was apparently referring to the protesting Youth Congress workers being heckled by some people at the AI Summit.
On February 20, a group of Indian Youth Congress (IYC) workers staged a dramatic protest inside Hall No. 5 of the summit venue in Delhi by removing their shirts to reveal T-shirts printed with anti-government slogans, triggering a political slugfest between the BJP and the Congress.
“Congress can tear as many clothes as it wants, but we will continue to work for India's development. Congress not just shed clothes at the AI Summit, it also exposed its incapabilities in front of foreign guests,” Modi said in his nearly 45-minute speech.
He said the AI Summit was a moment of pride for the entire nation, but unfortunately, Congress attempted to tarnish this national celebration.
"When the frustration and despair of failure weigh on the mind, and arrogance makes one's head spin, such a mindset emerges to defame the country," he said.
The prime minister also alleged that the Congress always takes refuge in Mahatma Gandhi to hide its failures, but tries to give credit to one family for anything good.
"People of our country welcomed every good step taken by our government, but the Congress only knows how to oppose everything. The votes of Congress are not stolen; rather, people do not consider Congress worthy of their votes. Millennials first taught a lesson to Congress, now Gen-Z is ready to do the same," he said.
Modi also said that in a democracy, the role of the opposition is not just about blindly opposing every move of the government, but presenting an alternative vision, and that is why the "enlightened public" of the country is "teaching a lesson" to Congress now.
In 1984, the Congress got 39 per cent of the votes and more than 400 seats. But its votes declined consistently in the subsequent elections, Modi said.
"Today, the condition of the Congress is such that it has more than 50 MLAs in just four states. Over the past 40 years, the number of young voters in the country has increased, but the Congress has clearly diminished," Modi said.
On the recent trade deals that India signed with foreign countries, Modi said the country has discovered its inherent strength and strengthened its institutions, which prompted developed nations to come forward and sign deals with India.
He also said that even after Independence, some people ensured that the colonial mindset remained for their own benefits.
"No country would have done trade deals with us had we not discovered our inherent strength and strengthened our institutions. Because of this, developed nations have come forward to sign trade deals (with India)," he said.
Modi also said that even after Independence, India was unable to break free from the mentality of slavery, for which the country is still paying the price.
"The latest example of this can be seen in the ongoing discussions on trade deals. Some people are shocked – ‘what has happened, how did this happen? Why are developed countries so eager to do trade deals with India?’ The answer is – a confident India is emerging from despair and frustration," he said.
Over the long span of history, centuries of slavery had instilled a feeling of inferiority, while the ideology imported from other countries deeply ingrained in society the notion that Indians were uneducated and subservient, the prime minister said.
"If the country was still mired in the despair of the pre-2014 era, counted among the 'Fragile Five', and gripped by policy paralysis, who would strike a trade deal with us?
"Over the past 11 years, a new surge of energy has flowed into the nation's consciousness. India is now striving to reclaim its lost potential," Modi said.
The prime minister also said that due to the recent series of reforms initiated by his government, the world's most powerful nations are now coming forward to sign trade deals with India.
"There was a time when India was only a consumer of new technology. But now we are not just developing them, but also setting standards," he said.
The prime minister also said that India's digital public infrastructure has become a subject of global discussion today, and every move India makes is closely watched and analysed across the world.
"The AI Summit was a clear example of this," he said.
The government's 'Viksit Bharat by 2047' is not a political slogan but an effort to correct the mistakes of the previous Congress governments by making India self-reliant, he said.
“So far, in every industrial revolution, India and the Global South largely remained followers, but in this age of artificial intelligence (AI), India is not only participating but is also shaping it. India now has its own AI startup ecosystem,” Modi said.
He also said the world is astonished that India, where around 30 million families lived in darkness until 2014, has now risen to become one of the top countries in solar power capacity.
India, where many cities had no hope of improving their public transport system, has now become the country with the world's third-largest Metro network, Modi said.
“The Indian Railways was known only for chronic delays and sluggish speeds, yet semi-high-speed connectivity like Vande Bharat and Namo Bharat has now become possible,” he said.
Nation-building never happens through short-term thinking; it is shaped by a long-term vision, patience and timely decisions, the prime minister added.
