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☆ FDA authorizes additional omicron Covid booster for seniors and people with weak immune systems
▼ + stars: | 2023-04-18 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

(Photo by Scott Olson/Getty Images)The Food and Drug Administration on Tuesday authorized an additional dose of Pfizer and Moderna 's Covid-19 vaccines targeting the omicron variant for seniors and people with weak immune systems. People with weak immune systems can receive another omicron shot at least two months after their last dose and receive additional shots at the discretion of their doctor. Children 6 months through 5 years of age who are unvaccinated can now receive the full two-dose series of Moderna's omicron vaccine. The FDA first authorized the omicron BA.5 shots last August, but that subvariant has long since been displaced by a version of omicron called XBB.1.5. In June, the agency will likely update the variant that the Covid vaccines target, ahead of the fall respiratory virus season.

☆ COVID-19 vaccination for health workers no longer mandatory, but favoured, France's health body says
▼ + stars: | 2023-03-30 | by ( ) www.reuters.com time to read: +1 min

[1/2] A medical worker prepares a dose of the "Cominarty" Pfizer-Bivalent coronavirus disease (COVID-19) vaccine at a vaccination center in Nice as a new surge in the COVID-19 outbreak starts in France, December 7, 2022. REUTERS/Eric Gaillard/File PhotoPARIS, March 30 (Reuters) - France's public health authority Haute Autorite de Sante (HAS)on Thursday eased its vaccination guidance for professionals in the health sector, saying the shot was no longer mandatory, but still strongly recommended, in light of recent epidemiological data. France's decision at the height of the pandemic to suspend the work contracts of doctors, nurses and other health workers who refused to take a COVID-19 vaccination, was highly controversial. The government had argued the move was necessary to keep hospitals safe, while unions said it further reduced available workforce in France's chronically under-staffed health sector. Reporting by Tassilo Hummel, editing by Charlotte Van CampenhoutOur Standards: The Thomson Reuters Trust Principles.

☆ U.S. FDA to soon decide on second round of Omicron-tailored boosters - WSJ
▼ + stars: | 2023-03-21 | by ( ) www.reuters.com time to read: +2 min

The agency continues to closely monitor the emerging data in the United States and globally, and that data will dictate any decision on additional updated boosters, the FDA said in a statement. The Centers for Disease Control and Prevention would have to recommend the shots after the FDA authorizes the second Omicron-tailored boosters from Pfizer-BioNTech (PFE.N)/(22UAy.DE) and Moderna (MRNA.O) for them to become widely available. Updated boosters have helped prevent symptomatic infections against the new XBB-related subvariants, according to data released by the CDC in January. The FDA authorized the so-called bivalent COVID boosters in August that target the BA.4 and BA.5 Omicron subvariants, along with the original strain of the coronavirus. Rollout of the updated boosters in the United States started the following month.

☆ U.S. FDA expands authorization of Pfizer bivalent COVID-19 shots in kids
▼ + stars: | 2023-03-14 | by ( ) www.reuters.com time to read: +1 min

March 14 (Reuters) - Pfizer Inc (PFE.N) said on Tuesday that the U.S. Food and Drug Administration had expanded the emergency use authorization (EUA) of the company and its partner BioNTech SE's (22UAy.DE) bivalent COVID-19 vaccine as a single booster dose in certain children. The amended authorization is for children six months through four years of age who have completed their initial three-dose vaccination with Pfizer's original shot. In December, the U.S. health regulator had authorized Pfizer/BioNTech's updated shot as a third dose to those aged six months through four years, who have not completed their primary vaccination series or are yet to receive the third dose. Shots for youngest children in the United States were only approved in June last year, making them the last group to become eligible for vaccination. Reporting by Pratik Jain; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

☆ FDA authorizes Pfizer's Covid omicron booster as fourth shot for kids under 5
▼ + stars: | 2023-03-14 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

The U.S. Food and Drug Administration on Tuesday authorized Pfizer's omicron booster shot for kids under five years old who were previously vaccinated with three doses of the company's original vaccine. The new shot is bivalent, meaning it targets the original Covid strain as well as omicron BA.4 and BA.5. Pfizer's primary series for young children consists of three doses, while rival drugmaker Moderna's primary series for that same age group is only two. Since December, children in that age group who completed two doses of Pfizer's original vaccine have been eligible to receive the omicron booster as their third shot, or last dose in their primary series. One month after the children received the omicron booster, they demonstrated an immune response to both the original Covid strain and omicron BA.5 and BA.5

In 2023, it expects revenue to be $67 billion to $71 billion. Excluding the COVID-19 drugs, Pfizer expects 2023 revenue to grow 7% to 9%. Pfizer developed its COVID-19 vaccine with German partner BioNTech , and the companies split the profits. The U.S. drugmaker forecast 2023 sales of $13.5 billion from the shot, below Refinitiv estimates of $14.39 billion, and projected $8 billion in sales of Paxlovid, short of analysts' expectation of $10.33 billion. After that transition, the company hopes to roughly quadruple the U.S. price of the COVID-19 vaccine.

☆ Pfizer forecasts weak 2023 sales of COVID products
▼ + stars: | 2023-01-31 | by ( ) www.reuters.com time to read: +1 min

REUTERS/Eric GaillardCompanies Pfizer Inc FollowJan 31 (Reuters) - Pfizer Inc (PFE.N) on Tuesday forecast a steeper-than-expected drop in sales of its COVID-19 vaccine and pills in 2023, intensifying investor concerns over demand for the products as governments reduce orders. The forecast casts some uncertainty over future sales of Pfizer's biggest selling products this year, which are expected to come under pressure as government spending on COVID vaccines and treatments declines. The U.S. drugmaker said it expects sales of $13.5 billion from the vaccine for 2023, below Refinitiv estimates of $14.39 billion, and projected $8 billion in sales of its antiviral pill, Paxlovid, short of analysts' expectation of $10.33 billion. That compared with sales of $37.81 billion for the vaccine and $18.93 billion for Paxlovid in 2022. Reporting by Manas Mishra and Bhanvi Satija in Bengaluru; Editing by Sriraj Kalluvila and Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

An advisory committee to the Food and Drug Administration on Thursday raised doubts about shifting toward a yearly Covid booster for most adults and children, saying too many questions about the virus still remain unanswered. The FDA convened its Vaccine and Related Biology Products Advisory Committee to discuss how the Covid vaccines may change moving forward. On Monday, the agency published briefing documents proposing annual Covid shots that target the latest variants of the virus — an approach similar to the yearly flu shot. Some committee members said they would prefer to make multiple yearly meetings on the Covid vaccines the norm. In a unanimous vote, the committee recommended using the bivalent formula in all Covid vaccines moving forward, not just for booster shots.

☆ Exclusive: EU may pay more for Pfizer COVID shots in return for lower volume
▼ + stars: | 2023-01-27 | by ( Maggie Fick | ) www.reuters.com time to read: +5 min

A Pfizer spokesperson declined to comment on details of the discussions, but said the company has shown ongoing commitment to accommodating EU member state concerns. Most people in the EU who wanted a primary course of the COVID-19 vaccine, and those who were later eligible for boosters, have received them. In May 2021, Brussels signed a contract with Pfizer and BioNTech to buy 900 million doses, with an option for an additional 900 million doses, by the end of 2023. Around half or more of the first 900 million doses from that contract have not yet been delivered because demand dropped last year. That came after EU governments warned Pfizer and other companies that millions of doses could go to waste.

☆ FDA doesn't see increased risk of stroke for seniors who received Pfizer's omicron booster
▼ + stars: | 2023-01-26 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

The CDC's Vaccine Safety Datalink, which monitors serious reactions to vaccines, showed a possible risk of stroke in late November. The FDA launched an extensive review of federal data after investigators at the Centers for Disease Control and Prevention detected a possible risk of stroke for seniors who received Pfizer's booster. The Food and Drug Administration hasn't found an increased risk of stroke for seniors who've received Pfizer's omicron booster shot, a federal health official said Thursday. The FDA reviewed CMS data from 4.25 million seniors who received Pfizer's omicron booster and did not identify any increased stroke risk. The Department of Veterans Affairs has also conducted preliminary review of its database and did not identify an increased stroke risk, Forshee said.

☆ FDA advisors recommend replacing original Covid vaccine with bivalent omicron shots for all doses
▼ + stars: | 2023-01-26 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The Food and Drug Administration's independent advisory committee on Thursday unanimously recommended replacing Pfizer and Moderna's original Covid vaccine used in the U.S. for everyone's first two immunizations with the new bivalent omicron shots. Instead, the drugmakers' bivalent omicron shots that target the omicron BA.5 subvariant as well as the original strain would be used for the entire vaccination series. Currently, Pfizer's and Moderna's omicron shots are only authorized as a booster, while the first two doses are still their old shots based on the original Covid strain. The FDA has proposed moving to a system that resembles how the agency updates and rolls out flu shots every year. The agency would select a Covid vaccine formulation in June to target the variant that is expected to dominate in the fall and winter.

☆ U.S. CDC still looking at potential stroke risk from Pfizer bivalent COVID shot
▼ + stars: | 2023-01-26 | by ( Michael Erman | ) www.reuters.com time to read: +2 min

U.S. Food and Drug Administration officials said they had not detected a link between the shots and strokes in two other safety monitoring databases. The new data was presented at a meeting of outside experts that advise the FDA on vaccine policy. Most of the confirmed cases had also received a flu vaccine at the same time, which might be a factor, she said. FDA scientist Richard Forshee said the agency plans to study whether there is any increased risk of stroke from receiving the two shots at the same time. Both agencies still recommend older adults receive the booster shots, now tailored to target Omicron variants as well as the original coronavirus.

☆ Updated Covid boosters cut the infection risk from XBB.1.5 subvariant by half, CDC finds
▼ + stars: | 2023-01-25 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +4 min

The updated Covid boosters reduce the risk of Covid infection from the predominant omicron subvariant by nearly half, according to early data published Wednesday by the Centers for Disease Control and Prevention. The findings are “quite reassuring,” Dr. Brendan Jackson, the head of the CDC’s Covid response, said on a call with reporters Wednesday. As of last Wednesday, only about 15% of people in the U.S. had received an updated booster, according to CDC data. People who were vaccinated but had not received the updated booster were compared to those who got the updated booster in the previous two to three months. People who got the updated boosters are probably "much more likely to wear masks indoors or restrain their travel or not go to indoor restaurants," he said.

☆ FDA proposes simplifying the Covid vaccine schedule, making it similar to the flu shot
▼ + stars: | 2023-01-23 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +3 min

Food and Drug Administration advisers will meet Thursday to discuss simplifying the Covid vaccination schedule, allowing most people to get the currently available booster, regardless of how many doses they had received before that. The FDA is proposing skipping over that primary series, meaning that most unvaccinated individuals could go ahead and get the latest booster shot if they decided to get a Covid vaccine. The FDA’s proposal, experts say, would greatly simplify the Covid vaccination schedule in the United States — aligning it more closely with the annual flu shot. In another similarity to the flu shot, the FDA is considering whether the Covid vaccine should be updated at least once a year, based on what strains are in circulation. Dr. Anna Durbin, a vaccine researcher at Johns Hopkins University in Baltimore, said simplifying the Covid vaccine schedule makes sense.

☆ The Deceptive Campaign for Bivalent Covid Boosters
▼ + stars: | 2023-01-23 | by ( Allysia Finley | ) www.wsj.com time to read: 1 min

You might have heard a radio advertisement warning that if you’ve had Covid, you could get it again and experience even worse symptoms. The message, sponsored by the Health and Human Services Department, claims that updated bivalent vaccines will improve your protection. This is deceptive advertising. But the public-health establishment’s praise for the bivalent shots shouldn’t come as a surprise. Federal agencies took the unprecedented step of ordering vaccine makers to produce them and recommending them without data supporting their safety or efficacy.

☆ FDA says Covid vaccines will probably get an annual update but most people will likely need only one shot
▼ + stars: | 2023-01-23 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

In a briefing document published Monday, the FDA said the vaccines will probably need an annual update as the virus continues to evolve. Most people would receive one shot to restore their protection against the virus moving forward, according to the briefing document. The FDA released the road map ahead of a meeting of the agency's independent vaccine experts scheduled for Thursday. The proposed system for updating Covid vaccines resembles how the FDA selects flu shots every year. The agency said it could update and rollout the Covid vaccines without clinical data, which is also the case with the annual process to change the flu shot.

☆ U.S. FDA proposes shift to annual COVID vaccine shots
▼ + stars: | 2023-01-23 | by ( ) www.reuters.com time to read: +2 min

It has also asked the panel to consider the usage of two COVID vaccine shots a year for some young children, and in older adults and persons with compromised immunity. The regulator also sought its advisers' views on the need for routine selection of variants for updating the vaccine, similar to the way strains for flu vaccines are changed annually. The agency expects that simplifying the COVID vaccine composition and annual immunization schedules may contribute to less complicated vaccine deployment, fewer vaccine administration errors and less complex communication, which could potentially lead to improved vaccine coverage rates. Currently, most people in the United States need to first get two doses of the original COVID vaccine spaced 3-4 weeks apart, depending on the vaccine, followed by a booster a few months later. The FDA's proposal follows the European regulator's backing last month for the use of bivalent COVID shots for primary vaccination.

☆ CDC says it’s ‘very unlikely’ Pfizer booster carries stroke risk for seniors after launching review
▼ + stars: | 2023-01-13 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

A CDC spokesperson said this issue was first detected in late November. By mid-December, the CDC concluded the concern was persisting and launched an investigation into whether seniors are more likely to have a stroke in the first 21 days after receiving the Pfizer booster, the spokesperson said. The VSD monitoring system found that 130 people ages 65 and older had a stroke within 21 days of receiving the Pfizer omicron booster among about 550,000 seniors who received the shot, the CDC spokesperson said. No other surveillance system has detected a similar safety concern for the Pfizer booster so far, according to the CDC. The CDC has not changed its recommendation for the Pfizer omicron shot.

☆ U.S. FDA, CDC see early signal of Pfizer bivalent COVID shot's link to stroke
▼ + stars: | 2023-01-13 | by ( ) www.reuters.com time to read: +2 min

Jan 13 (Reuters) - A safety monitoring system flagged that U.S. drugmaker Pfizer Inc (PFE.N) and German partner BioNTech's updated COVID-19 shot could be linked to a type of brain stroke in older adults, according to preliminary data analyzed by U.S. health authorities. An ischemic stroke, also known as brain ischemia, is caused by blockages in arteries that carry blood to the brain. "Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public," the health authorities said. Pfizer and BioNTech said in a statement that they have been made aware of limited reports of ischemic strokes in people 65 and older following vaccination with their updated shot. This safety concern has not been identified with Moderna's (MRNA.O) bivalent shot and both the CDC and FDA continue to recommend that everyone aged 6 months and older stay up-to-date with their COVID-19 vaccination.

A key adviser to the Food and Drug Administration's vaccine panel is questioning whether more Covid booster shots are necessary for healthy, younger people. The FDA later backed the vaccine panel, authorizing a new formulation of the booster shots. “The people who are talking about why young people need it are missing the point,” he said, referring to the booster. Levy, the director of the Precision Vaccines Program at Boston Children’s Hospital, continues to encourage Covid boosters for everyone who is eligible. Relatively few people in the U.S. have had updated boosters.

☆ Mainland Chinese head to Hong Kong for mRNA COVID vaccines
▼ + stars: | 2023-01-12 | by ( Joyce Zhou | ) www.reuters.com time to read: +2 min

HONG KONG, Jan 12 (Reuters) - Scores of mainland Chinese travellers are rushing to Hong Kong to receive mRNA COVID-19 vaccines, which are not available on the Chinese mainland, as the country grapples with a torrent of infections which have overwhelmed its health system. A private hospital in the special Chinese administrative region of Hong Kong welcomed the first batch of mainland customers on Thursday, just five days after China reopened its borders for the first time in three years, allowing quarantine free travel. [1/5] Yoyo Liang, from mainland China, received a dose of BioNTech bivalent coronavirus disease (COVID-19) vaccine at a private clinic in Hong Kong, China January 12, 2023. There is no bivalent vaccine available in mainland Chin," she explained after she received her jab. Virtus, which has received more than 300 inquiries so far about the vaccines, is expecting more mainland customers to come to Hong Kong in the coming weeks and months, the company's chief medical officer Samuel Kwok told reporters.

☆ Where Are the Next Covid Treatments?
▼ + stars: | 2023-01-10 | by ( The Editorial Board | ) www.wsj.com time to read: 1 min

The worst of the Covid pandemic is over, but danger persists as new virus variants spread that may evade current vaccines and antibody treatments. Yet the Biden Administration is foot-dragging on treatment development and approvals needed to save lives. The Administration wants Americans to get bivalent booster shots that target the BA.4/5 variants. While these Omicron descendants predominated over the summer and early fall, they have been overtaken in much of the U.S. by new variants that dodge antibodies from boosters, prior infection and monoclonal treatments.

☆ Omicron COVID booster cuts hospitalization in over 65s, Israeli study finds
▼ + stars: | 2023-01-09 | by ( ) www.reuters.com time to read: +1 min

The study by researchers from healthcare provider Clalit, Ben-Gurion University of the Negev and Sapir College has not yet been peer reviewed. The study was carried out from the end of September until mid-December and looked at 622,701 people aged 65 and over who were eligible for the bivalent booster. "Hospitalization due to Covid-19 occurred in 6 bivalent recipients and 297 participants who did not" receive it, the study said. "Participants who received the bivalent vaccine had lower hospitalization and mortality rates due to Covid-19 than non-recipients up to 70 days after vaccination." While the bivalent vaccine targets the original strain and its BA.4/BA.5 Omicron subvariant, scientists have been closely watching another Omicron subvariant, XBB.1.5, which has been rapidly spreading in the United States.

☆ Omicron XBB.1.5 is rising in U.S. though revised CDC data shows slower increase than previously reported
▼ + stars: | 2023-01-06 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

XBB.1.5 made up 27.6% of sequenced Covid cases nationally for the week ending Jan. 7 compared with 18.3% for the week end Dec. 31. The CDC previously reported that XBB.1.5 made up about 41% of sequenced cases for the week ending Dec. 31, more than any other variant. Although the agency has revised its estimate downward, XBB.1.5 remains the only omicron subvariant showing significant growth in the U.S. right now. U.S. health officials should have more data soon on how much protection the omicron boosters provide against XBB.1.5., Jha said. Weekly Covid cases have increased by about 16% to 470,699 over the past week, according to CDC data.

The subvariant of omicron, named XBB.1.5, has raised concerns about another potential wave of Covid cases following the busy holiday travel season. The CDC projected Friday that about 40% of confirmed U.S. Covid cases are caused by the XBB.1.5 strain, up from 20% a week ago. There’s no indication it causes more severe illness than any other omicron virus, Dr. Barbara Mahon, director of CDC’s Coronavirus and Other Respiratory Viruses Division, told NBC News. The XBB.1.5 is a relative of the omicron XBB variant, which is a recombinant of the omicron BA.2.10.1 and BA.2.75 subvariants. Yet, only 37.5% of that age group has received the most recent omicron booster, according to the most recent CDC data.

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