The United States on Wednesday authorized Pfizer Inc’s antiviral COVID-19 pill for at-risk people aged 12 and above, making it the first oral treatment and which can be taken at home, providing a potentially important tool in the fight against the fast-spreading Omicron variant.
Pfizer’s antiviral regimen, Paxlovid, was nearly 90 percent effective in preventing hospitalizations and deaths in patients at high risk of severe illness, according to data from the company’s clinical trial. Recent lab data suggests the drug retains its effectiveness against Omicron, Pfizer said.
“We’re talking about a staggering number of lives saved and hospitalizations prevented. And of course, if you deploy this quickly after infection, we are likely to reduce transmission dramatically,” Pfizer Chief Scientific Officer Mikael Dolsten said, calling it “a stunning outcome.”
Pfizer raised its 2022 production projections to 120 million courses of treatment from 80 million and said it was ready to start immediate delivery in the United States. The treatment’s two-drug regimen includes a new medicine and a second older antiviral called ritonavir.
“Paxlovid’s approval is a major milestone that marks another step towards making COVID-19 a much more manageable infection,” said Amesh Adalja, a senior scholar at the Johns Hopkins Institute for Health Security.
“There are two key issues, however, that remain: It will be scarce in the coming weeks and its optimal use requires prompt diagnosis, which can be difficult with the continual testing problems that plague us,” Adalja added.
Pfizer has said it has 180,000 treatment courses ready to ship this year. The U.S. government’s contract for 10 million courses of the drug is priced at $530 per course.
The Food and Drug Administration’s decision to issue emergency authorization for the treatment comes as the U.S. combats a surge in COVID-19 cases driven by the Omicron variant, with President Joe Biden announcing plans for more federal vaccination and testing sites.
The pills can fill a treatment gap opened by the Omicron variant, said William Schaffner, a leading infectious disease expert from the Vanderbilt University School of Medicine. The most widely used monoclonal antibody treatments for COVID-19 have proven to be less effective at fighting the variant and there is limited supply of the one remaining treatment that works, he said.
Monoclonal antibodies are typically given intravenously in hospitals, are not widely available and are more than twice the cost of the Pfizer pill.
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‘Taking Us All for Fools’: Critics Decimate Greg Abbott’s Claims and Defense of His Actions in Wake of School Shooting
Texas Republican Governor Greg Abbott in a press conference that left reporters frustrated defended his actions and insisted his earlier praise for law enforcement’s widely criticized response to the Uvalde school massacre was the result of being “misled.”
“I am livid about what happened,” Abbott declared, blaming others for his “recitation of what people in that room told me.”
“I was misled … the information that I was given turned out in part to be inaccurate. And I’m absolutely livid about that” — Greg Abbott on his initial false statement portraying Uvalde first responders as heroes pic.twitter.com/dUIdxnicjm
— Aaron Rupar (@atrupar) May 27, 2022
Critics aren’t buying his claims.
Abbott, who’s in the middle of a heated re-election campaign, appeared extremely defensive when reporters asked him questions.
“Let’s be clear about one thing. None of the laws I signed this past session had any intersection with this crime at all,” Abbott told reporters when asked if he would call the legislature back for a special session, as The Texas Tribune’s Sewell Chan noted.
“No law that I signed allowed him to get a gun,” Abbott insisted.
“The answers fell pretty flat,” opined MSNBC’s Nicolle Wallace, who noted the press event lasted just 36 minutes, less time than the police officers “stood outside and did nothing,” which was 47 minutes.
Abbott ended the press conference with many reporters almost begging him to take more questions. As the governor left one frustrated reporter was caught on a hot mic saying “unbelievable.”
Chan, who is the editor in chief of the Tribune, added on Twitter: “Abbott rejects background checks as a simplistic and ineffective fix. Wouldn’t have prevented Sutherland Springs and Santa Fe shootings, he says. Tries to turn focus to broken mental health system.”
Former FBI assistant director for counterintelligence Frank Figliuzzi on MSNBC delivered a strong rebuke to Governor Abbott’s remarks.
“No amount of free flights, no amount of free caskets, no amount of mental health counseling is going to bring back any one of those murdered children,” Figliuzzi said, referring to Abbott’s announcement an anonymous donor is putting up $175,000 for funeral expenses of those who were murdered in the shooting and said the state will pay for mental health treatment.
Abbott also insisted that since Texas became a state it’s been legal for 18-year-olds to buy long guns.
Fred Guttenberg, whose daughter Jaime was murdered in the Parkland school shooting, blasted Abbott:
.@GregAbbott_TX responding to a question on long rifles “it seems like only in the past decade or two we have had school shootings.” Governor, the assault weapons ban ended in 2004. See the connection? You have actively helped to sell millions of weapons since then.
— Fred Guttenberg (@fred_guttenberg) May 27, 2022
And long guns of today, as Figliuzzi noted, are often semi-automatic “killing machines.”
“The governor seems completely unable to understand that he can easily make a distinction when you’re talking about whether an 18-year-old should buy an assault rifle or not. And all he cares about is a century of history in Texas on long guns. We didn’t have the AR-15 style assault weapons back then. He can easily make a distinction and say, ‘you can go hunting, here are the rifles you can do, you can buy, you can possess – and here’s an assault-style rifle.'”
“If he thinks that people are stupid and unable to understand that there is a clear distinction between a killing machine and a hunting rifle, that he’s taking us all for fools.”
‘I Apologize for Interrupting Your Press Conference’: Tearful Texas Democrat Urges Greg Abbott to ‘Do Something’ on Guns
The Texas Democratic State Senator who represents Uvalde stood up during Greg Abbott’s Friday afternoon press conference and almost begged the Republican Governor to “do something” about gun violence after Tuesday’s massacre at Robb Elementary School that took 21 lives.
Abbott was trying to place the blame for the school shooting on mental health despite the gunman having no documented issues, and told attendees, “we’re focusing our attention on the wrong thing.”
That was not good enough for Democratic State Senator Roland Gutierrez, who politely introduced himself and said, “I’m not making a political speech.”
“My colleagues are asking for a special session, you’re getting a letter tomorrow,” from the Senate Democratic Caucus.
“We’ve asked for gun control changes – I’m asking you now, bring us back in three weeks.”
Gutierrez grew emotional, sounding as if he was choking up, and added, “I apologize for interrupting your press conference about the needs of this community. I’ve been here for three days with all of these elected officials – this county judge has been working his ass off,” he continued.
“I don’t know how to express the loss of the families that I’ve talked to,” he added.
“You have to do something, man,” Gutierrez said, all but begging the governor to take action, and saying his “own colleagues are calling me and telling me this is enough.”
“I’m sorry to interrupt your press conference… you have to do something” pic.twitter.com/OiRI1OQZWQ
— Acyn (@Acyn) May 27, 2022
Local Texas Cops Blocked Specialized Federal Tactical Team That Killed Shooter From Engaging for One Hour
When a specially equipped U.S. Border Patrol tactical team arrived on the scene of Tuesday’s school shooting in Uvalde, Texas, local police who were already on the scene wouldn’t allow them to engage with the shooter, The New York Times reports.
“The agents from Border Patrol and Immigration and Customs Enforcement arrived at some point between 12 p.m. and 12:10 p.m., according to the officials — far earlier than previously known,” The Times’ report stated. “But they did not breach the adjoining classrooms of the school where the gunman had locked himself in until a little before 1 p.m. Members of the federal tactical team killed the gunman.”
But officials speaking to The Times say the Uvalde Police Department prevented the agents from going in sooner.
The new details further call into the question the thinking behind how law enforcement responded to the shooting that killed 19 students and two teachers. The Border Patrol and ICE agents say they did not understand why they were force to wait. All of the 21 victims died in the area where 18-year-old Salvador Ramos had barricaded himself in.
Read the full report at The New York Times.
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