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The Food and Drug Administration made its assessment in briefing documents ahead of a meeting of the agency's external advisers on Thursday to discuss full approval to use Pfizer's oral pill for high-risk COVID-19 patients exhibiting mild to moderate symptoms. Paxlovid has been authorized for emergency use since late 2021, and a full approval is likely to allow Pfizer to expand its advertising campaign for the drug. Over 12 million courses have been delivered to pharmacies, and patients have used over 8 million courses of the treatment, according to Federal data. Paxlovid has shown reduction in risk of hospitalization or death by 86% in non-hospitalized, high-risk adult patients in Pfizer' study, which did not include vaccinated participants. Reporting by Leroy Leo and Khushi Mandowara in Bengaluru; Editing by Shailesh Kuber and Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.
The House passed a bipartisan bill that would require the Biden administration to declassify information related to COVID-19's origins. The origins of COVID-19 have long been debated and theorized. The House of Representatives unanimously approved the bill, titled the COVID-19 Origin Act of 2023, in a 419-0 vote on Friday. The bill comes after the US Energy Department recently concluded with "low confidence" that the pandemic was likely the result of a lab leak. Indeed, lawmakers could likely override a potential veto with a two-thirds vote in both the House and Senate.
Moderna on Thursday missed earnings expectation for the fourth quarter, as costs rose from surplus production capacity and lower demand for its Covid-19 vaccine, the company's only product on the market. Moderna reported quarterly earnings of $3.61 per share, a 68% decrease from the same period in 2021 when it booked $11.29 per share. Moderna has signed contracts for $5 billion in Covid vaccine deliveries for 2023. Moderna estimates U.S. market volume in fall 2023 will be 100 million doses, said Arpa Garay, the company's chief commercial officer. Garay said Moderna will leverage the infrastructure it already has in place for Covid to launch the RSV vaccine.
House Republicans have asked former White House chief medical advisor Dr. Anthony to testify before Congress as they launch a new investigation into the origins of the Covid-19 pandemic. "If there are oversight hearings I absolutely will cooperate fully and testify before the Congress," Fauci told reporters during his final briefing at the White House. He stepped down from his posts at the White House and at the helm of the National Institute of Allergy and Infectious Diseases in December. EcoHealth Alliance provided funding, which originated at NIH, to the Wuhan Institute of Virology to study coronaviruses. About $600,000 of that money went directly to the Wuhan Institute of Virology to study the threat posed by bat coronaviruses.
At Davos 2023, Moderna CEO Stephane Bancel spoke about how quickly the company was able to scale up vaccine production at the start of the COVID-19 pandemic, not that Moderna had made 100,000 COVID vaccine doses before the pandemic began, as some are claiming online. The clip of Bancel responding to a question in January 2023 circulated in a tweet by the user @healthbyjames with the false caption, “URGENT — Moderna CEO Stéphane Bancel Admits Company Produced 100,000 COVID-19 Vaccine Doses In 2019 Before The Pandemic Started” (here). Bancel responds by first recalling that, “when the pandemic happened, Moderna had made 100,000 dose in 2019 for the whole year. Moderna did not produce 100,000 doses of the COVID-19 vaccine in 2019, Ridley said. Moderna CEO Stephane Bancel did not say in a 2023 panel discussion that the company produced 100,000 COVID-19 vaccines prior to the pandemic.
Users online are circulating that widely-known fact to imply the COVID-19 pandemic was planned. At timestamp 0:17-0:42, Bancel says Moderna was working on a COVID-19 vaccine before the virus had an official name, saying “I think there was no name at that time” (here). On Jan. 23, 2020, the WHO-affiliated Coalition for Epidemic Preparedness Innovations (CEPI) announced funding for three separate research teams to work on potential vaccines against the novel coronavirus (here). One of the research teams included a partnership between drug and vaccine developer Moderna and the U.S. National Institute of Allergy and Infectious Diseases. Neither the disease nor the virus that causes it had formal names until February 2020.
The only HIV vaccine in a late-stage trial has failed, researchers announced Wednesday, dealing a significant blow to the effort to control the global HIV epidemic and adding to a decadeslong roster of failed attempts. “I don’t think that people should give up on the field of the HIV vaccine,” Fauci said. Fauci said that a critical limitation of the Mosaico vaccine was that it elicited what are known as non-neutralizing — as opposed to neutralizing — antibodies against HIV. As with the Thai trial, the hope is to channel research findings into future HIV vaccine development. To prove a vaccine works, researchers must recruit participants who remain at substantial risk of HIV over time.
David Kessler, a key official in the Biden administration's Covid vaccine and treatment efforts, is stepping down from his role as chief science officer, the Department of Health and Human Services announced Friday. Since January 2021, Kessler has played a leading role in the development and roll out Covid vaccines. Kessler, 71, is the latest Covid response official to step down at President Joe Biden's two-year mark in office. The Biden administration and health officials have had to combat misinformation and conspiracy theories about Covid vaccines during their rollout. The latest figures from the Centers for Disease Control and Prevention show that 78.8% of U.S. adults have completed their primary series of Covid vaccines.
Anthony Fauci said he has "no idea" what Elon Musk is talking about in regard to the "Fauci Files." Musk teased the release of the files following his previous criticism of the medical expert. Fauci told the CBS News podcast "The Takeout": "I have no idea what he's talking about. Meanwhile, journalists appointed by Musk have been discussing several controversies arising from what have been called the "Twitter Files." They include internal discussions regarding the decision to ban former President Trump from Twitter following the deadly Capitol riots on January 6, 2021.
Elon Musk said the next Twitter Files release would include information about Anthony Fauci. Musk targeted the doctor and scientist in December by tweeting: "My pronouns are Prosecute/Fauci." Musk targeted Fauci in early December when he tweeted: "My pronouns are Prosecute/Fauci." Meanwhile, journalists appointed by Musk have been discussing several controversies arising from what are known as the Twitter Files. But the Twitter CEO and some freelance journalists are annoyed that the Twitter Files haven't received more support from the press.
— A Mississippi man who threatened to kill Centers for Disease Control and Prevention Director Rochelle Walensky has pleaded guilty to making threats in interstate commerce, federal prosecutors announced Monday. Robert Wiser Bates, 39, of Ridgeland, threatened to kill Walensky in voicemails left in July 2021 at the CDC headquarters in Atlanta, Georgia, court records said. He also said he would kill Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases and chief medical advisor to the president. In August, a West Virginia man was sentenced to three years in federal prison after he sent emails threatening Fauci and another federal health official for talking about the coronavirus and efforts to prevent its spread. He faces a maximum penalty of five years in prison and a $250,000 fine.
CEO of Tesla Motors Elon Musk speaks at the Tesla Giga Texas manufacturing "Cyber Rodeo" grand opening party in Austin, Texas, on April 7, 2022. U.S. electric truck maker Rivian has fallen by 27% over that period. Shares in electric vehicle maker Tesla have fallen 28% since October 27, when CEO Elon Musk bought Twitter and appointed himself "Chief Twit," or CEO, of the social media business. Musk sold billions of dollars' worth of his Tesla holdings to finance the Twitter takeover. Since he took over the company, Musk has been regularly posting incendiary tweets, especially aimed at people who hold center-to-left political values, and whom Musk often paints as enemies with a "woke mind virus."
Reps. Marjorie Taylor Greene and Lauren Boebert want in on the GOP oversight blitz. the Oversight Committee member said of the need to keep congressional probes above board. McCarthy's office has repeatedly told Insider that the House GOP steering committee, which McCarthy leads, will handle assignments for the next Congress "at the appropriate time." Aaron Cutler, a former House GOP leadership aide and now partner at Hogan Lovells, urged House Republicans to avoid "focusing on the wrong things," and to cut bait if needed. Michael Reynolds-Pool/Getty ImagesGiven that some sort of spectacle is probably unavoidable at this point, Roe urged House Republicans to tread carefully.
Local officials mulling over masksThe US Centers for Disease Control and Prevention offers specific guidance on when masking is recommended based on its Covid-19 community levels. The agency says that people may choose to wear masks at any time but that a “high-quality mask or respirator” is recommended for everyone when a county has a “high” Covid-19 community level. As of Thursday, about 5.66% of US counties have high community levels, including some places in Arizona, Wyoming, Oregon and the Dakotas. Even without a mandate, she emphasized community efforts like wearing masks inside when possible and getting Covid-19 vaccines or boosters. “We do know that 5% of the population is living in places with a high Covid-19 community level.
The current rise in Covid-19 cases is one leg of a triple threat – a “tridemic,” a “tripledemic” or a “trifecta,” as some news organizations are calling it – along with a bad flu season and an RSV outbreak hitting mainly children. People at higher risk of getting sick should wear masks when there is medium spread, such as in Los Angeles County. “You can count masking, vaccines, boosting, testing – all of that is part of the spectrum of protecting yourself and your family,” Fauci said. But if Covid-19 cases were to increase, a little less than two-thirds of Americans, 65%, said they would wear a mask. This will be the conundrum for public health officials if Covid-19 cases continue along with this “tripledemic” – how to get people to wear masks without trying to make them do it.
Anthony Fauci, the federal government's top infectious disease expert and a chief proponent of Covid vaccines, sharply criticized the "extreme" ideological divide that he said has led to a disproportionate amount of coronavirus deaths among Republicans compared to Democrats. In an interview with NBC News' Lester Holt scheduled to air Wednesday night, Fauci said he thought political viewpoints had a measurable effect on the number of people who could have been saved by the coronavirus vaccine. It’s part of our democracy, part of what makes our country great. But when they get so extreme that it prevents you from doing something that’s life saving, that is really awful," he said. Watch the full interview on “NBC Nightly News with Lester Holt” tonight at 6:30 p.m. ET/5:30 p.m. CT.Several studies have found that Covid deaths are unevenly distributed among Republicans and Democrats.
There have been nearly 17 flu hospitalizations for every 100,000 people, rates typically seen in December or January. The cumulative hospitalization rate hasn’t been this high at this point in the season in more than a decade. Less than two months in, the RSV hospitalization rate this season is already nearing the total RSV hospitalization rate from the entire 2018-19 season. With the holiday season – and flu season – underway, Dr. Anthony Fauci warned this week of the potential for an emergency situation. “When you have very little wiggle room of intensive care beds, when you have like almost all the intensive care beds that are occupied, it’s bad for the children who have RSV and need intensive care.
Dr. Anthony Fauci, the top infectious disease expert in the U.S., criticized China's Covid lockdowns as "draconian" and said the Beijing government should focus on vaccinating the elderly. Fauci said lockdowns are only justifiable as a temporary measure to serve a larger public health goal that will make society safer when it reopens. But China's strict Covid controls don't seem to have any endgame, he said. Rare protests broke out across China over the weekend against Covid lockdowns and strict quarantine procedures. "The efficacy of the China-made vaccines are not at the level of the vaccines that have been used in the United States, particularly the mRNA vaccines of Moderna and Pfizer," Fauci said.
Dr. Anthony Fauci said on NBC's "Meet the Press" that China's approach has been "rather draconian." On CNN's "The Lead with Jake Tapper," Fauci said lockdowns should be temporary. "Their approach has been very, very severe and rather draconian in the kinds of shutdowns without a seeming purpose," Fauci said in an interview on Sunday with NBC's "Meet the Press" host Chuck Todd. On CNN's "The Lead with Jake Tapper," Fauci reiterated on Monday that China needs to communicate a clear reason to the population for having lockdowns. Part of China's so-called "zero-COVID" strategy is to completely eradicate infection cases in areas where even a small number of coronavirus cases are found by implementing stringent lockdowns.
And the CDC estimates that there have been at least 6.2 million illnesses, 53,000 hospitalizations and 2,900 deaths from influenza this season. Less than two months in, the RSV hospitalization rate this season is already nearing the total RSV hospitalization rate from the entire 2018-19 season. The latest surveillance data does not capture Thanksgiving week or the effects of holiday gatherings. Covid-19 cases, hospitalizations and deaths reached record high levels during last year’s holiday season – and this holiday season could also bring a rise in spread. Flu shots are lagging, too, with millions fewer vaccinations at this point in the season than in the past two years.
CNN —The Covid-19 pandemic has carried a key lesson for public health officials, Dr. Anthony Fauci said Monday: When talking to Americans, be clear that science is often a moving target. “Hopefully, we could have been more on top of appreciating the dynamic nature of how things change, thinking that it wasn’t aerosol spread in the beginning, and then you find out it is aerosol spread. Experts agree that the virus almost certainly jumped into humans from an animal market in China but that they may never know for sure. “It’s possible that there was a lab leak,” Fauci said. Fauci criticized China’s controversial zero-Covid policy, saying shutdowns “should always be a temporary phenomenon, not a long-range strategy,” and should be done with an end point in mind, such as buying time to secure PPE or provide vaccinations.
Dr. Anthony Fauci, White House chief medical advisor, speaks during a briefing on COVID-19 at the White House on November 22, 2022 in Washington, DC. The nation's top infectious disease expert, Dr. Anthony Fauci, said the U.S. is "certainly" still in the middle of a Covid-19 pandemic and he is "very troubled" by the divisive state of American politics. "I don't care if you're a far-right Republican or a far-left Democrat, everybody deserves to have the safety of good public health and that's not happening." The 81-year-old became a household name during the Covid-19 pandemic, battling back against misinformation — sometimes from the highest levels of government. White House Covid-19 Response Coordinator Dr. Ashish Jha said Sunday he knows it has been a long two years for Americans, but that it is still "incredibly important" to get vaccinated ahead of the holiday season.
WASHINGTON — Dr. Anthony Fauci appeared Tuesday at his final White House press briefing, as he prepares to leave government next month following a half-century on the front lines of the world's gravest public health crises. “The idea that this may be very likely the last time I’m in that press briefing room is kind of sad. Things can’t go on forever," Fauci said in an interview earlier in the day with NBC News. Before he announced his plans to leave government, Fauci said he would not serve under another Trump administration. "What I would like to do is encourage and perhaps inspire younger people to get involved in science, medicine and public health," Fauci said.
NIH National Institute of Allergy and Infectious Diseases Director Anthony Fauci addresses the daily press briefing at the White House in Washington, January 21, 2021. Dr. Anthony Fauci on Tuesday will give what is expected to be his last public briefing on the Covid-19 pandemic as the White House chief medical advisor. He will give an update alongside Dr. Ashish Jha, head of the White House Covid task force. They are expected to encourage people to get their Covid boosters and flu shots as soon as possible. Public health officials have repeatedly warned that the U.S. will likely face another wave of Covid this winter as people travel and gather for the holidays.
Dr. Anthony Fauci on Tuesday reflected on the U.S. response to the Covid-19 pandemic in what was likely his last public briefing as the nation's top infectious disease expert. Nearly three years after Covid-19 first arrived on America's shores, Fauci said he never imagined the pandemic would last so long and take so many lives. "I did not imagine and I don't think any of my colleagues imagined that we would see a three-year saga of suffering and death and a million Americans losing their lives," Fauci, 81, told reporters during a Covid update at the White House. Fauci is stepping down in December as head of the National Institute of Allergy and Infectious Diseases after nearly 40 years at the helm, and as White House chief medical advisor. He said the most disturbing feature of Covid was the evolution of multiple variants over time.
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