DUBAI: Pfizer Inc’s experimental antiviral pill to treat COVID-19 was shown to cut by 89 percent the chances of hospitalization or death for adults at risk of developing severe disease, the company said on Friday.
It also comes as an offer to what could be a promising new weapon in the fight against the pandemic.
The trial’s results suggest that the oral drug surpasses Merck & Co. Inc’s pill, molnupiravir, which was shown last month to halve the risk of dying or being hospitalized for COVID-19 patients at high risk of serious illness.
Pfizer’s pill, with the brand name Paxlovid, could secure US regulatory approval by the end of the year. The Pfizer trial was stopped early due to its high success rate. Full trial data is not yet available from either company.
President Joe Biden said the US government has secured millions of doses of the Pfizer drug.
“If authorized by the FDA we may soon have pills that treat the virus in those who become infected,” Biden said. “The therapy would be another tool in our toolbox to protect people from the worst outcomes of COVID.”
Shares in Pfizer, which also makes one of the mostly widely used COVID-19 vaccines, were up 9 percent to $47.82, while Merck’s were down 9.3 percent to $82.09. Shares of vaccine makers took a hit, with Moderna Inc, Pfizer’s German partner BioNTech SE and Novavax all down 13-21 percent.
The pill is given in combination with an older antiviral called ritonavir. The treatment consists of three pills given twice daily. It has been in development for nearly two years.
Pfizer is in discussions with 90 countries over supply contracts for its pill, Chief Executive Officer Albert Bourla said in an interview.
Bourla said Pfizer expects to price its treatment close to where Merck has priced its pill. Merck’s US contract price for its pill is around $700 for a five-day course of therapy.
Even with the potential offered by the Pfizer and Merck pills, preventing COVID-19 infections through broad use of vaccines remains the best way to control a pandemic that has killed more than 5 million people worldwide, including more than 750,000 in the United States, according to infectious disease experts.
“Vaccines are going to be the most effective and reliable tool that we have in this pandemic,” said Dr. Grace Lee, professor of pediatrics at Stanford University School of Medicine. “These oral medications are going to augment our ability to really reduce the risk of severe disease, hospitalization and death, which is huge, but it won’t prevent infection.”
While more than 7 billion vaccine doses have been administered worldwide, that has covered only about half the world’s people. In the United States, 58 percent of all people, including 70 percent of adults, are fully vaccinated. There are more than 400,000 new COVID-19 cases daily worldwide, with infections rising in 50 countries.
Mizuho analyst Vamil Divan forecast a “very minor impact” from the Pfizer drug on vaccination among people who do not want the vaccine or a booster shot as recommended by US health regulators.
“I think there’s a small percentage of people that may decide not to get vaccinated, now that there are good treatment options,” Divan said.
Pfizer said it plans to submit interim trial results for its pill to the Food and Drug Administration (FDA) before the US Thanksgiving holiday on Nov. 25.
The company said it expects to manufacture 180,000 treatment courses by the end of this year and at least 50 million courses by the end of next year, including 21 million in the first half of 2022.
Antivirals need to be given as early as possible, before an infection takes hold, to be most effective.
The planned analysis of 1,219 patients in Pfizer’s study examined hospitalizations or deaths among people diagnosed with mild to moderate COVID-19 with at least one risk factor for developing severe disease, such as obesity or older age.
Among those given Pfizer’s drug within three days of symptom onset, the pill lowered the chances of hospitalization or death for adults at risk of developing severe COVID-19 by 89 percent compared to patients who received a placebo. Among these patients, 0.8 percent were hospitalized and none died by 28 days after treatment, compared to a 7 percent hospitalization rate and seven deaths in the placebo group.
Rates were similar for patients treated within five days of symptoms: 1 percent of the treatment group was hospitalized, compared to 6.7 percent for the placebo group, which included 10 deaths. Pfizer said that works out to being 85 percent effective at preventing hospitalization or death.
An FDA panel of outside experts is scheduled to meet Nov. 30 to discuss Merck’s pill, which was approved by British regulators https://www.reuters.com/business/health care-pharmaceuticals/britain-approves-mercks-oral-covid-19-pill-2021-11-04 in a world first on Thursday. Pfizer said it did not know if Paxlovid would be reviewed at that meeting.
Pfizer did not detail side any effects but said adverse events happened in about 20 percent of both treatment and placebo patients. Possible side effects include nausea and diarrhea.
Pfizer is holding discussions about a license for generic manufacturing of the pill for low-income countries, Unitaid’s Medicines Patent Pool said in a statement.
Pfizer says its antiviral pill slashes risk of severe COVID-19 by 89 percent
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Pfizer says its antiviral pill slashes risk of severe COVID-19 by 89 percent
- Pfizer's pill, with the brand name Paxlovid, could secure U.S. regulatory approval by the end of the year
- President Joe Biden said the U.S. government has secured millions of doses of the Pfizer drug
Pro-Palestinian protesters target military and defense industry recruiters at UK universities
- Activists confront Royal Air Force recruiters at careers fairs in Newcastle, Glasgow, York and Cardiff
- About 20 defense companies reportedly forced to steer clear of events because of security risks
LONDON: The UK’s military and defense industries are being forced to avoid university careers fairs because of pro-Palestinian protesters.
Student activists have targeted representatives of the Royal Air Force in recent months during events at which they were attempting to recruit graduates, The Times newspaper reported.
Videos and images shared on social media show RAF recruiters shutting down display stands or leaving them while the protests take place.
About 20 defense companies have stopped attending university careers events because of security concerns about the protests, it was reported last week.
The demonstrations are part of the widespread activism in the UK in response to Israel’s military operations in Gaza that have killed more than 46,000 Palestinians since the Oct. 7, 2023, Hamas-led attacks on Israel in which about 1,200 people were killed and at least 250 taken hostage.
Protesters have also targeted the factories of UK defense companies that supply Israel, and called on the British government to halt arms deliveries.
One protest group, called “Newcastle Apartheid Off Campus,” claimed to have shut down a recruitment fair at Newcastle University at which the RAF and defense firm BAE Systems were represented.
And about 20 students surrounded the recruitment stands of GE Aerospace, the RAF and BAE Systems at Glasgow University in October.
“The students managed to kick out BAE Systems, RAF and (defense and intelligence company) CGI,” the Glasgow University Justice for Palestine Society said in a message posted on Instagram.
“Shame on Glasgow University, we continue to demand divestment and cutting all ties with these genocidal companies.”
Similar disruptions took place at a recruitment fair at York University in October and during an RAF talk at Cardiff University the same month.
In a letter to ministers, Lord Walney, the UK government’s independent adviser on political violence and disruption, warned that the protests go beyond peaceful assembly and could “seriously undermine our nation’s security and technical edge.”
A Ministry of Defence spokesperson told The Times: “We continue to engage widely with our industry partners to highlight the importance and significant benefits of a career in the defense sector.
“This government recognizes the vital role of the defense sector as an engine for growth, strengthening our security and economy.”
Los Angeles firefighters brace for threat of more powerful winds
- Local officials urged residents to stay vigilant throughout the day on Wednesday and be prepared to evacuate at a moment’s notice
- Some 6.5 million people remained under a critical fire threat
LOS ANGELES: The threat of powerful wind gusts combined with bone-dry humidity in Los Angeles on Wednesday could pose a severe test for firefighters who have been battling to keep monstrous fires in check since last week.
Local officials urged residents to stay vigilant throughout the day on Wednesday and be prepared to evacuate at a moment’s notice, even after tamer-than-expected winds over the last 24 hours.
“We want to reiterate the particularly dangerous situation today. Get ready now and be prepared to leave,” County Supervisor Lindsey Horvath said during a news conference on Wednesday.
Some 6.5 million people remained under a critical fire threat as winds were forecast to be 20 to 40 miles (32-64 km) an hour with gusts up to 70 mph and humidity dropping into the single digits during the day, the National Weather Service said.
The combination of low humidity and strong winds has further dried out the brush, increasing the risk of fire, Los Angeles City Fire Chief Kristin Crowley said.
“The danger has not yet passed,” she said, noting that firefighters have seen up to 40 mph winds on Wednesday.
The death toll from the fires stood at 25. The estimate of structures damaged or destroyed held steady at over 12,000, portending a Herculean rebuilding effort ahead. Entire neighborhoods have been leveled, leaving smoldering ash and rubble. In many homes, only a chimney is left standing. Some 82,400 residents were still under evacuation orders with other 90,400 facing evacuation warnings, County Sheriff Robert Luna said.
Winds were tamer than expected on Tuesday, letting firefighters extinguish or gain control of some small brush fires that ignited. No major wildfires erupted in the area, as had been feared.
During the day, the milder-than-expected conditions also allowed some 8,500 firefighters from at least seven states and two foreign countries to hold the line on the Palisades and Eaton fires for the second day running.
The Palisades Fire on the west edge of town held steady at 23,713 acres (96 square km) burned, and containment nudged up to 19 percent — a measurement of how much of the perimeter was under control. The Eaton Fire in the foothills east of the city stood at 14,117 acres (57 sq km) with containment at 45 percent. The fires have consumed an area the size of Washington, D.C.
“In the past 24 hours, there has been little to no fire growth on both incidents,” Cal Fire Incident Commander Gerry Magaña said.
A fleet of aircraft dropped water and retardant into the rugged hills while ground crews with hand tools and hoses have worked around the clock since the fires broke out on Jan. 7, with the aircraft occasionally grounded by high winds.
Crowley and Los Angeles Mayor Karen Bass fielded questions on Wednesday about a Los Angeles Times report that 1,000 firefighters were on standby but not quickly deployed after fire broke out on Jan. 7.
“We did everything in our capability to surge where we could,” Crowley said.
Southern California has lacked any appreciable rain since April, turning brush into tinder as Santa Ana winds originating from the deserts whipped over hilltops and rushed through canyons, sending embers flying up to two miles ahead of the fires.
Private forecaster AccuWeather estimates total damage and economic loss between $250 billion and $275 billion, which would make it the costliest natural disaster in US history, surpassing Hurricane Katrina in 2005.
Danish PM tells Trump it is up to Greenland to decide on independence
- Trump said last week that US control of Greenland was an “absolute necessity“
- Frederiksen also emphasized the importance of strengthening security in the Arctic
COPENHAGEN: Denmark’s Prime Minister Mette Frederiksen said on Wednesday she had spoken on the phone with US President-elect Donald Trump and told him that it is up to Greenland itself to decide on any independence.
Trump, who takes office on Jan. 20, said last week that US control of Greenland was an “absolute necessity” and did not rule out using military or economic action such as tariffs against Denmark to make it happen.
“In the conversation, the prime minister referred to the statements of the Chairman of the Greenlandic Parliament, Mute B. Egede, that Greenland is not for sale,” Frederiksen’s office said in a statement.
“The prime minister emphasized that it is up to Greenland itself to make a decision on independence,” the statement said.
Frederiksen also emphasized the importance of strengthening security in the Arctic and that Denmark was open to taking a greater responsibility, it added.
Russia planned ‘acts of terrorism’ in the air, Polish PM says
- The explosions occurred in depots in Britain, Germany and Poland in July
- Russia has denied involvement in the incidents and Tusk did not mention them specifically
WARSAW: Russia planned ‘acts of terrorism’ in the air against Poland and other countries, Polish Prime Minister Donald Tusk said on Wednesday after meeting Ukrainian President Volodymyr Zelensky in Warsaw.
Security officials have said that parcels that exploded at logistics depots in Europe were part of a test run for a Russian plot to trigger explosions on cargo flights to the United States. The explosions occurred in depots in Britain, Germany and Poland in July. Russia has denied involvement in the incidents and Tusk did not mention them specifically.
“The latest information can confirm the validity of fears that Russia was planning acts of terrorism in the air not only against Poland,” Tusk told a news conference. He did not say what acts he was referring to or elaborate on the contents of the information.
Moscow has regularly denied any involvement in the courier depot explosions, as well as break-ins, arson and attacks on individuals which Western officials say were carried out by operatives paid by Russia. The Russian embassy in Warsaw has not immediately replied to an emailed request for comment on Tusk’s statement.
US must not become complacent to a growing terrorism threat, a Counterterrorism Center official says
US must not become complacent to a growing terrorism threat, a Counterterrorism Center official says
- “We are in a period where we are facing an elevated threat environment,” Holmgren said
- He also points to mass migration from the Russia-Ukraine war that has sent central Asians to countries including Turkiye, Syria, Iraq and even the US
UNITED STATES: Brett Holmgren got woken up early on New Year’s Day by alerts that a driver had plowed into a crowd of revellers in New Orleans.
The rampage, which killed 14 people, was the deadliest attack on US soil in years and was inspired by the Daesh group.
The National Counterterrorism Center, which Holmgren leads, sprang into action to help the FBI run down information on the culprit from Texas and his plot.
It was a rare recent example of a mass attack motivated by religious extremism to hit the US homeland. But it didn’t occur in a vacuum, coming at a time when a terror threat that has waxed and waned in the two decades since the Sept. 11, 2001, attacks is decidedly on the rise around the world.
“We are in a period where we are facing an elevated threat environment,” Holmgren said in an interview with The Associated Press. “We faced that last year. We’re going to face it again in 2025.”
The NCTC emerged in the aftermath of 9/11 as a centralized US government hub to collect and analyze data and intelligence on the international terrorism threat, providing information to the White House and other agencies to shape policy decisions and protect against attacks.
A former counterterrorism analyst and assistant secretary of state, Holmgren was named its acting director last July and intends to step aside at the conclusion of the Biden administration.
At that point, new leadership under President-elect Donald Trump will grapple with managing some of the global hot spots like Syria that have vexed officials in recent months and that the NCTC has been tracking.
Holmgren cites multiple factors for why the threat is higher than before, including passions arising from the Israel-Hamas war — a conflict that he says has been a driving factor in some 45 attacks worldwide since October 2023. He also points to mass migration from the Russia-Ukraine war that has sent central Asians, some with ties to the Daesh group, to countries including Turkiye, Syria, Iraq and even the US
Around the world, officials are monitoring tensions in Africa, which Holmgren called potentially the greatest long-term threat to US security given that the Daesh group has a large footprint on the continent and is investing resources there.
He says the “most potent overseas threat facing the United States” right now is the group’s Afghanistan-based affiliate, known as Daesh-Khorasan, whose attacks include a March 2024 massacre at a Moscow theater and the August 2021 bombing that killed 13 US service members and about 170 Afghans in the chaotic US withdrawal from Afghanistan.
One ongoing spot of concern is Syria, where an insurgent group named Hayat Tahrir Al-Sham, or HTS, led a lightning offensive last month that toppled the government of President Bashar Assad.
HTS is a Sunni Islamist group that formerly had ties with Al-Qaeda, although its leader has preached religious coexistence since taking over in Damascus. The group has not plotted against US interests in recent years and has been “the most effective counterterrorism partner on the ground,” Holmgren said.
HTS has been designated by the State Department as a foreign terror organization, a label that carries severe sanctions.
Asked whether that designation would remain, Holmgren said that was a policy decision, though he noted: “They want to be perceived as being on the right side of the international community at this time when it comes to (counterterrorism). But we will continue to evaluate not just their words but also the actions that they’re undertaking.”
In an indication of Syria’s continued instability, Defense Secretary Lloyd Austin told The Associated Press last week that the US needs to keep troops there to prevent the Daesh group from reconstituting, and intelligence officials in Syria’s new de facto government already have thwarted a plan by Daesh to set off a bomb at a Shiite shrine in a Damascus suburb.
US officials, meanwhile, remain concerned about the possibility of Daesh gaining strength by taking over weapons left behind by Assad’s government or through a mass release of fighters who are now imprisoned.
“A large-scale prisoner release in Syria could provide a real boost in the arm for IS at a time where they have been under significant pressure,” Holmgren said.
The counterterrorism center’s focus is on international terrorism, which includes cases in the US like the New Orleans rampage in which the attacker was inspired by a group from abroad. The culprit, 42-year-old Shamsud-Din Jabbar, pledged his allegiance to Daesh in videos he recorded just before he drove his speeding pickup truck into a crowd on Bourbon Street early on Jan. 1.
As of now, Holmgren said, there’s no evidence that Jabbar was communicating with any Daesh operatives overseas or guided by anyone, but given that he was a lone actor who was radicalized, “this symbolizes exactly the type of attack that we’ve warned about for some time.”
“And I think it illustrates that while we have been quite effective as a government and across administrations at disrupting plotting overseas and going after terrorist leaders, we have a lot more work to do when it comes to countering violent extremism at home, countering violent extremist propaganda abroad,” he added.
“That is ultimately what is going to be needed to prevent more attacks like the one in New Orleans,” Holmgren said.
By the same token, through vast intelligence collection, hardened defenses and overseas counterterrorism operations, the US has made the risk of another large-scale attack like Sept. 11 lower than it’s ever been.
“But if we get complacent as a country,” he warned, “it will come back to bite us.”
