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Oct 23 (Reuters) - U.S. President Joe Biden will get his updated COVID-19 vaccine on Tuesday and urge more Americans to get the latest shot, White House spokesman Kevin Munoz said on Sunday. Only 20 million people in the United States have received an updated COVID vaccine through last week. "We need everyone to step up and get their updated vaccine as soon as possible," she said. The United States started rolling out the updated COVID shots in September, designed to take on the circulating BA.4 and BA.5 Omicron subvariants and the original version of the virus. Biden in July tested positive for COVID with mild symptoms and tested positive in a rebound case seen in a small percentage of people who take the antiviral drug Paxlovid.
CNN —Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention, tested positive for Covid-19 Friday. Walensky is experiencing mild symptoms and is up-to-date on her Covid-19 vaccines, according to a statement released by the agency. Walensky received an updated Covid-19 booster in September. The updated Covid-19 booster shots are bivalent, meaning they target the original coronavirus strain as well as the Omicron BA.4/BA.5 subvariants. The booster doses are recommended to given at least two months after the last dose of any Covid-19 vaccine and up to three months after an infection.
Oct 21 (Reuters) - Pfizer's plan to as much as quadruple current U.S. prices for its COVID-19 vaccines going forward could spur revenue for years, analysts said. Outside the United States, Pfizer said it already has contracts with governments in many developed markets that extend through 2023 with prices that have already been set. Moderna had previously suggested commercial price expectations in a range of $64 to $100 a shot. Wall Street was expecting such price hikes due to weak demand for COVID vaccines, which meant manufacturers would need to hike prices to meet revenue forecasts for 2023 and beyond. Around 19.4 million people in the United States received the updated booster over the first seven weeks of its rollout.
Experts say: prepare for more COVID infections this winter. But "among the new variants, XBB has the most significant immune evasion properties," market forecasters at Morgan Stanley said Thursday in a memo. Experts say we should expect many more infections this fall and winter, including infections in vaccinated, boosted Americans. But there are some simple things you can do to prepare to battle XBB and other evasive COVID variants on the horizon. Both have a slight growth advantage over BA.5, which is the dominant version of COVID right now in the US.
CNN —A flurry of new Covid-19 variants appears to be gaining traction globally, raising fears of a winter surge. As the US moves into the fall, Covid-19 cases are dropping. But virus experts fear that the downward trend may soon reverse itself, thanks to this gaggle of new variants. Lumped together, the variants accounted for almost 1 in 3 new Covid-19 infections nationwide last week, according to the latest estimates from the US Centers for Disease Control and Prevention. The updated bivalent booster vaccines and antiviral drugs like Paxlovid are expected to continue to be protective against severe outcomes from Covid-19 infections caused by the new variants.
Other omicron subvariants that have piqued the interest — and concerns — of scientists read like a viral alphabet soup: BQ.1, BQ.1.1, BF.7. Ever since the omicron variant emerged, it's been omicron all the way down, with omicron subvariants splitting off into their own subvariants. Barouch's study was small, including just 35 people who'd had either the Covid vaccine or an omicron infection. Most, regardless of prior infection, had at least three doses of Covid vaccine. The World Health Organization is tracking more than 300 omicron subvariants worldwide, Maria Van Kerkhove, head of the WHO’s emerging diseases and zoonosis unit, said during a media briefing Wednesday.
Oct 19 (Reuters) - Moderna Inc (MRNA.O) said on Wednesday its COVID-19 vaccine booster targeting the BA.1 subvariant of Omicron generated a strong immune response against that variant, with antibody levels staying high for at least three months. Omicron-tailored shots by Pfizer Inc (PFE.N) and Moderna are already authorized by regulators in several countries. The United States has given the go-ahead for booster vaccines that target the currently circulating BA.4 and BA.5 subvariants of Omicron. "Clinical trial data now indicates that the superior immune response produced by our bivalent booster has durability for at least three months," Moderna Chief Executive Officer Stephane Bancel said in a statement. Moderna said it expects data from human trials of its BA.4/BA.5 targeted vaccine later this year.
CNN —Novavax’s Covid-19 vaccine is now available in the United States for use as a first booster dose for people 18 and older. The company said its booster is for adults for whom a Pfizer/BioNTech or Moderna updated booster vaccine is not accessible or clinically appropriate, and for adults who elect to receive the Novavax vaccine because they would otherwise not get a booster dose of a Covid-19 vaccine. “The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster,” Novavax President and CEO Stanley Erck said in a news release Wednesday. Novavax executives have long suggested that their Covid-19 vaccine could be used as a booster dose, even for people who got another vaccine type as their primary series. The most common side effects reported with the Novavax booster were pain or tenderness at the injection site, fatigue, muscle pain and headache.
As winter inches closer, Dr. Fauci is sounding the alarm about a pair of "pretty troublesome" Covid variants. There's no guarantee that the two strains will eventually overtake BA.5 as the dominant variant in the country. But if they do spread rapidly, they could threaten to reverse a nationwide decline in Covid cases, hospitalizations and deaths, leading Fauci to urge Americans against letting their guard down. Scientists from Peking University in China published a study earlier this month that found BQ.1.1's ability to evade antibodies was "far exceeding" that of BA.5. The CDC recommends masking indoors if you're in a county with a substantial or high-level spread of Covid.
If you already got your omicron-specific Covid booster, you might have experienced some side effects. But there's no need to worry: Experts and new data say the new shots appear to work — regardless of whether you experience moderate, mild or no side effects at all. The new boosters gained approval from the U.S. Food and Drug Administration and the CDC before they finished clinical trials. Like previous Covid vaccines, the new boosters are designed to help you fight the virus by triggering an immune response in your body. Covid vaccines typically take two to three weeks to fully ramp up your immunity, which can help your body stop an infection from happening or keep it from progressing to severe disease.
New offshoots of the Omicron Covid-19 variant that virus experts say appear to spread easily are on the rise in the U.S. , the latest federal data show. Two of the Omicron subvariants, both related to the BA.5 version that drove the most recent U.S. surge, are called BQ.1 and BQ.1.1. They were estimated to represent a combined 11.4% of U.S. Covid-19 cases by mid-October, according to estimates the Centers for Disease Control and Prevention released Friday.
The results are based on blood samples taken from adults one week after they received the updated booster. The FDA also authorized Moderna's updated booster based on similarly limited data. The FDA authorized the updated shots based on studies in mice — plus human trial results from a similar booster that targets the original omicron strain, called BA.1. At the time, Dr. Peter Marks, the FDA's top vaccine regulator, said the agency hoped the updated vaccines will provide stronger protection against symptomatic disease than the older vaccines. Moderna didn't immediately respond to a request for comment about when it will release new data on its updated booster.
Oct 13 (Reuters) - Pfizer (PFE.N) and its German partner BioNTech said their COVID-19 vaccine booster, adapted for the BA.4 and the BA.5 subvariants of Omicron, generated a strong immune response and was well-tolerated in testing on humans. With the results, which the companies described as consistent with preclinical data, the partners are following up with human trial data that had previously been missing from their successful filings for regulatory approval. Register now for FREE unlimited access to Reuters.com RegisterThey did not disclose the levels of antibodies generated in the preliminary analysis of the study. Healthcare regulators for the European Union and the United States had already approved the upgraded shot last month, even though trial data from testing on humans had at the time not been available. “While we expect more mature immune response data from the clinical trial of our Omicron BA.4/BA.5-adapted bivalent vaccine in the coming weeks, we are pleased to see encouraging responses just one week after vaccination in younger and older adults," said Pfizer Chief Executive Albert Bourla.
There has been evidence that the omicron variant tends not to burrow deeply into the lungs as much as previous variants. How quickly do omicron symptoms appear? What is the duration of omicron symptoms? Although much about the omicron variant remains unknown, some experts say it could lead to long Covid, even with mild cases. The BA.5 omicron subvariant accounted for nearly 80% of new Covid cases as of Oct. 8, according to the CDC.
The Food and Drug Administration on Wednesday authorized updated Covid booster shots that target the omicron variant of the virus for young children. The decision will now go to the Centers for Disease Control and Prevention, which could issue its final recommendation on the updated shots within hours. Only about 31% of children ages 5 to 11 have received two doses of any Covid vaccine, according to CDC data. Experts say it's important for people to receive the updated shots because the nation could face yet another potential wave of Covid infections this winter. The boosters are important because data has shown that any Covid vaccine greatly decreases the risk of severe outcomes from the virus, said O’Leary.
Oct 12 (Reuters) - U.S. health regulators authorized the use of Omicron-tailored COVID-19 booster shots from Moderna Inc (MRNA.O) and Pfizer Inc (PFE.N) in children as young as 5, a move that will expand the government's fall vaccination campaign. The U.S. Food and Drug Administration on Wednesday green-lighted Moderna's bivalent vaccine for those aged six and above, while Pfizer's updated shot was authorized in children aged five and above. The U.S. Centers for Disease Control and Prevention also backed the FDA's authorization, clearing the way for the shots to be administered in children. Overall, COVID-19 vaccination rates in the United States have stayed low among kids, with nearly 40% of children aged 5-11 vaccinated with one dose of a vaccine so far. Around 11.5 million people received the updated shots over the first five weeks of the rollout last month, which represents just 5.4% of the people aged 12 or older who are eligible to receive them.
White House COVID-19 Response Coordinator Dr. Ashish Jha speaks to reporters during a press briefing with White House Press Secretary Karine Jean-Pierre at the White House on July 25, 2022 in Washington, DC. The U.S. is tracking several coronavirus omicron subvariants that more easily evade immunity, but the new booster shots should protect against them, a top health official said on Tuesday. Health officials are closely watching the subvariants because they render many treatments ineffective, said Dr. Ashish Jha, head of the White House Covid task force. But the new booster shots available in the U.S. should provide a much higher degree of protection against the variants because they all descend from omicron BA.2 or omicron BA.5, Jha told reporters at the White House. The Biden administration had to shift money around to find funding to stockpile the new booster shots.
Americans have two options for a new omicron-specific Covid booster shot: Pfizer or Moderna. Pfizer's booster is cleared for anyone 12 and older, while Moderna's booster is for people 18 and older. "People ages 18 years and older may get a different product for a booster than they got for their primary series, as long as it is [Pfizer or Moderna,]" the CDC's website reads. "It's OK to mix and match Moderna and Pfizer," Dr. Ralph Gonzales, associate dean for clinical innovation at UC San Francisco, said at a campus town hall earlier this month. I definitely felt a stronger response with the Moderna — having had Pfizer before — but either combinations are fine."
CNN —There are signs that the United Kingdom could be heading into a fall Covid-19 wave, and experts say the United States may not be far behind. A recent increase in Covid-19 cases in England doesn’t seem to be driven by a new coronavirus variant, at least for now, although several are gaining strength in the US and across the pond. Spector runs the Zoe Health Study, which uses an app to let people in the UK and US report their daily symptoms. After seeing a downward trend for the past few weeks, the Zoe study saw a 30% increase in reported Covid-19 cases within the past week. In the US, some models have predicted that Covid-19 cases will begin to rise again in October and continue to increase into the winter.
(CNN) Younger children could soon be eligible to receive an updated Covid-19 booster shot. Pfizer and BioNTech on Monday said they completed their submission to the US Food and Drug Administration for emergency use authorization of their updated Covid-19 booster for children ages 5 through 11. Moderna on Friday said it had requested FDA authorization for its updated booster for adolescents ages 12 to 17 and for children ages 6 to 11. Like the boosters that became available for older people earlier this month, these bivalent boosters target the original coronavirus strain as well as the Omicron BA.4/BA.5 subvariants. Pfizer's updated booster is currently authorized for use in people 12 and older and Moderna's is authorized for adults age 18 and older.
A vial of the Pfizer-BioNTech coronavirus disease (COVID-19) booster vaccine targeting BA.4 and BA.5 Omicron sub variants is pictured at Skippack Pharmacy in Schwenksville, Pennsylvania, U.S., September 8, 2022. REUTERS/Hannah Beier/File PhotoSept 26 (Reuters) - Pfizer Inc (PFE.N) and its German partner BioNTech on Monday sought the U.S. Food and Drug Administration's authorization for an Omicron-tailored COVID-19 vaccine booster for children aged 5 through 11 years. The rollout of bivalent booster doses for older age groups has been off to a slow start in the United States compared to the rollout of the first boosters last year, with 4.4 million doses administered so far. read moreEarlier in the month, the U.S. Centers for Disease Control and Prevention said it expects COVID-19 vaccine boosters targeting circulating variants of the virus to be available for children aged 5-11 years by mid-October. Register now for FREE unlimited access to Reuters.com RegisterReporting by Leroy Leo and Khushi Mandowara in Bengaluru; Editing by Savio D'SouzaOur Standards: The Thomson Reuters Trust Principles.
A healthcare worker holds a vial of the Moderna COVID-19 Vaccine at a pop-up vaccination site operated by SOMOS Community Care during the coronavirus disease (COVID-19) pandemic in Manhattan in New York City, New York, U.S., January 29, 2021. REUTERS/Mike Segar/File PhotoSept 26 (Reuters) - The U.S. Food and Drug Administration said on Monday it has authorized an additional five batches of Moderna Inc's (MRNA.O) updated Covid booster shots made at a Catalent facility in Indiana, after it deemed them safe for use. Last week, the health regulator had allowed use of ten batches of Moderna's updated booster shots made at the Bloomington, Indiana facility, owned by a unit of Catalent Inc (CTLT.N), which is currently not a part of the company's emergency use authorization. The FDA had earlier said Moderna had requested authorization for additional batches in light of the current supply issues. The U.S. government, which has sent out over 25 million of the COVID-19 booster shots targeting BA.4 and BA.5 subvariants of Omicron, has ordered more than 170 million updated shots for this fall, in preparation for a broad revaccination campaign.
Pfizer CEO tests positive for COVID for a second time
  + stars: | 2022-09-24 | by ( ) www.reuters.com   time to read: +2 min
Register now for FREE unlimited access to Reuters.com RegisterAlbert Bourla, CEO of Pfizer attends a discussion at the World Economic Forum (WEF) in Davos, Switzerland May 25, 2022. REUTERS/Arnd WiegmannSept 24 (Reuters) - Pfizer Inc (PFE.N) Chief Executive Officer Albert Bourla said on Saturday he had tested positive for COVID-19. Bourla has received four doses of the COVID vaccine developed by Pfizer and its German partner BioNTech (22UAy.DE). A federal health agency said this week that over 25 million doses of the so-called bivalent shots had been sent out. read moreRegister now for FREE unlimited access to Reuters.com RegisterReporting by Mrinmay Dey in Bengaluru; Editing by Daniel WallisOur Standards: The Thomson Reuters Trust Principles.
At least 4.4 million people have received an updated Covid booster since the start of the month, according to data released Thursday by the Centers for Disease Control and Prevention. The CDC signed off on updated versions of Pfizer’s and Moderna’s booster shots on Sept. 1, and pharmacies and other vaccination sites began administering the new shots around Labor Day weekend. As of Tuesday, the U.S. had shipped more than 25 million bivalent booster doses to tens of thousands of sites. Some pharmacies reported shortages of Moderna's updated booster earlier this week. Biden administration officials have pointed to the updated boosters, however, as a critical step to pushing the U.S. out of the pandemic.
U.S. rollout of new COVID boosters off to slow start
  + stars: | 2022-09-23 | by ( ) www.reuters.com   time to read: +3 min
A nurse fills up syringes with the coronavirus disease (COVID-19) vaccines for residents who are over 50 years old and immunocompromised and are eligible to receive their second booster shots in Waterford, Michigan, U.S., April 8, 2022. The government said earlier this week it has shipped 25 million of the Omicron-tailored shots, mostly from Pfizer (PFE.N)/BioNTech (22UAy.DE). Last year, when the United States initially authorized COVID boosters just for older and immunocompromised people, nearly 10 million received their third shot in the first three weeks. The updated shots target the widely circulating BA.4 and BA.5 Omicron subvariants as well as the original version of the coronavirus included in all previous COVID vaccines. Moderna had been producing new boosters aimed at the older BA.1 Omicron subvariant when the FDA asked them to change course to address the currently dominant variants for the U.S. market.
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