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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.

☆ Pfizer says omicron shots substantially boosted antibodies against BA.5 subvariant in early human data
▼ + stars: | 2022-10-13 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Pfizer and its German partner BioNTech on Thursday said their new omicron boosters substantially increased protective antibodies against the dominant omicron BA.5 subvariant for adults in the first direct human data released to the public on the new shots. The participants who received the first generation vaccine saw a limited increase in antibodies against BA.5, according to the companies. The early data indicate that the safety profile of the new boosters is the same as the original vaccine, the companies said. The first generation shots were developed only against the first strain of the virus. The FDA authorized the omicron shots without direct human data on how they perform against omicron BA.5, which is causing most infections in the U.S. right now.

☆ Covid-19 Boosters Targeting Omicron Authorized for Kids as Young as 5
▼ + stars: | 2022-10-12 | by ( Peter Loftus | Liz Essley Whyte | ) www.wsj.com time to read: 1 min

U.S. health regulators on Wednesday expanded eligibility for the new Covid-19 booster shots to children as young as 5 years old, broadening access to help bolster protection against Omicron strains of the coronavirus. The U.S. Food and Drug Administration authorized the updated booster from Pfizer Inc. and its partner BioNTech SE for children ages 5 through 11, and Moderna Inc.’s updated booster for children 6 through 17.

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.

☆ Covid-19 Boosters Targeting Omicron Authorized by FDA for Kids as Young as 5
▼ + stars: | 2022-10-12 | by ( Peter Loftus | Liz Essley Whyte | ) www.wsj.com time to read: 1 min

☆ Omicron-Targeting Covid-19 Boosters Recommended for Kids as Young as 5
▼ + stars: | 2022-10-12 | by ( Peter Loftus | Liz Essley Whyte | ) www.wsj.com time to read: 1 min

☆ U.S. authorizes updated COVID booster shots for children as young as 5
▼ + stars: | 2022-10-12 | by ( ) www.reuters.com time to read: +2 min

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.

☆ Moderna pops 17% after Merck exercises option to jointly develop a personalized cancer vaccine
▼ + stars: | 2022-10-12 | by ( Matthew Fox | ) www.businessinsider.com time to read: +3 min

Moderna spiked as much as 17% on Wednesday after the company teamed up with Merck to develop personalized cancer vaccines. Data from an ongoing phase 2 trial of Moderna's vaccine used in combination with Merck's Keytruda is expected in the fourth quarter. Under an existing licensing agreement that was initially inked in 2016, Merck had the option to exercise an option to jointly develop and sell the personalized cancer vaccines. Merck will pay Moderna $250 million to exercise its option, and will collaborate on the development and commercialization of the vaccines. Merck's cancer drug Keytruda is currently being evaluated in combination with Moderna's mRNA-4156/V940 vaccine as a treatment for patients with high-risk melanoma.

☆ Pfizer exec denies CEO negotiated EU COVID vaccine contract via text message
▼ + stars: | 2022-10-10 | by ( ) www.reuters.com time to read: +1 min

FRANKFURT, Oct 10 (Reuters) - A Pfizer (PFE.N) executive with a lead role in negotiating a COVID-19 vaccine bulk supply agreement with the European Commission "categorically" ruled out that the U.S. drugmaker's chief executive agreed the contract via mobile phone text messages. She added that such talks involve far too many people on both sides and take far too long to be conducted via mobile phone texts. The Commission said in June this year that it no longer had the texts, which later drew criticism from the European Union's ombudswoman. The contract signed last year was the biggest ever sealed for COVID-19 vaccines, with the EU committing to buy 900 million Pfizer-BioNTech (22UAy.DE) shots, with an option to buy another 900 million. Register now for FREE unlimited access to Reuters.com RegisterReporting by Ludwig Burger; Editing by Jan Harvey and Susan FentonOur Standards: The Thomson Reuters Trust Principles.

☆ A series of mega-blockbuster drugs are on the horizon. How to invest in the trend
▼ + stars: | 2022-10-08 | by ( Christina Cheddar Berk | ) www.cnbc.com time to read: +4 min

"That said, the biggest drugs usually feature one, or best case two, of these attributes." Seven drugs on Meacham's list are already in the market, and have already hit the $10 billion or more benchmark. That means some of these drugs may be already hitting the end of their peak sales period. Meacham has previously said that one of the drugs in this bucket, Eli Lilly's tirzepatide, could be the first $100 billion drug . But many investors are hopeful about its potential as an obesity treatment .

BEIJING, Oct 7 (Reuters) - The mounting economic toll of China's zero-COVID policy is raising investor hopes that Beijing may finally begin laying the groundwork for the tricky epidemiological and political task of shifting course following this month's Communist Party congress. Goldman Sachs analysts predict China will start relaxing the policy in the April-June quarter. China boasts nine domestically developed COVID vaccines approved for use, more than any other country. REUTERS/Aly SongThe authorities have not approved any foreign-made COVID shots. Many countries offer second booster shots.

☆ Covid-19 boosters could prevent about 90,000 US deaths this winter, but only if more people get them, analysis suggests
▼ + stars: | 2022-10-05 | by ( Jacqueline Howard | ) edition.cnn.com time to read: +4 min

CNN —Covid-19 vaccinations could save thousands of lives and billions of dollars this winter. A new analysis suggests that if more people in the United States get their booster by the end of the year, about 90,000 Covid-19 deaths could be prevented this fall and winter. But if booster vaccinations continue at their current pace, the nation could see a peak of more than 1,000 Covid-19 deaths per day this winter, according to the study, published Wednesday by The Commonwealth Fund. There are now more than 400 daily Covid-19 deaths, on average, in the United States. Federal health officials have said that Americans may need to get a single updated Covid-19 vaccination every year.

☆ Covid vaccination linked to slight increase in menstrual cycle, NIH study confirms
▼ + stars: | 2022-09-28 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

However, the longer menstrual cycle, typically about a month long, didn't necessarily increase the number of days of bleeding, according to NIH. A change in menstrual cycle length of eight days or less is considered within the normal range of variation, according to NIH. Women who received both vaccine doses in a single menstrual period saw their cycle increase by 3.91 days. The changes in menstrual cycle length did not differ between vaccines. The researchers had released preliminary findings in January suggesting an association between Covid vaccination and increased menstrual cycle length, but the study published this week confirmed the link.

☆ Study links Covid-19 vaccination to small, temporary change in menstrual cycle
▼ + stars: | 2022-09-27 | by ( Naomi Thomas | ) edition.cnn.com time to read: +3 min

CNN —People who got the Covid-19 vaccine reported slightly longer menstrual cycles, but the change was temporary, according to a new study published Tuesday in the journal BMJ Medicine. “We found no differences in menses length in any group of vaccinated individuals, compared with the unvaccinated cohort,” the study says. The changes to the length of the cycle didn’t remain in the cycle after vaccination, the authors said – apart from in the group that received two doses in one cycle. For the vaccinated cohort, they looked at three prevaccine cycles and at least the first Covid-19 vaccine dose cycle. Nearly two-thirds of the 15,000 vaccinated participants had received the Pfizer/BioNTech vaccine, although participants had also received the Johnson & Johnson, Moderna and Oxford-AstraZeneca vaccines among others.

☆ Pfizer Requests Clearance for Children’s Covid-19 Booster
▼ + stars: | 2022-09-26 | by ( Jared S. Hopkins | Dean Seal | ) www.wsj.com time to read: 1 min

Pfizer Inc. and BioNTech SE asked U.S. health regulators to clear use of their updated Covid-19 booster in children 5 years to 11 years. The companies made the request on Monday as retooled shots for people 12 and older roll out across the country. Health authorities people to get the shots to increase protection against the virus in case of fall or winter surges.

☆ Pfizer wants approval for its Covid booster for children over 5 years old
▼ + stars: | 2022-09-26 | by ( The Associated Press | ) www.nbcnews.com time to read: +1 min

Pfizer asked U.S. regulators Monday to expand the use of its updated Covid-19 booster shot to children ages 5 to 11. Elementary school-aged children already received kid-sized doses of Pfizer’s original vaccine, a third of the dose given to everyone 12 and older — two primary shots plus a booster. Pfizer and its partner BioNTech also announced a new study of the omicron-focused booster in even younger children, those ages 6 months through 4 years, to test different doses. Updated boosters made by both Pfizer and rival Moderna rolled out earlier this month for everyone 12 and older. As of last week, the Centers for Disease Control and Prevention said 4.4 million Americans had gotten an updated booster so far.

☆ U.S. FDA clears additional lots of Moderna's Covid booster amid shortage
▼ + stars: | 2022-09-26 | by ( ) www.reuters.com time to read: +1 min

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/BioNTech seek FDA nod for new COVID boosters for children
▼ + stars: | 2022-09-26 | by ( ) www.reuters.com time to read: +1 min

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.

☆ Pfizer, Moderna seek authorization for updated Covid-19 boosters for younger children
▼ + stars: | 2022-09-26 | by ( Naomi Thomas | ) edition.cnn.com time to read: +1 min

(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.

☆ Valneva in talks with potential partner on second-gen COVID-19 vaccines
▼ + stars: | 2022-09-26 | by ( ) www.reuters.com time to read: +2 min

Register now for FREE unlimited access to Reuters.com RegisterValneva logo is seen displayed in this illustration taken, May 3, 2022. REUTERS/Dado Ruvic/Illustration/File PhotoPARIS, Sept 26 (Reuters) - French drugmaker Valneva (VLS.PA) said on Monday it is in talks with a potential partner on producing an updated version of its COVID-19 vaccine that targets new variants of the disease, sending its shares up. The French company has struggled to bring its COVID-19 vaccine to market to compete with rival products from drugmakers such as AstraZeneca, Moderna and BioNTech/Pfizer. "The company is in active discussions with a prospective partner for potentially funding the development of a second-generation COVID-19 vaccine," Valneva said. Register now for FREE unlimited access to Reuters.com RegisterReporting by Tassilo Hummel and Darmarah Mackos; Editing by Sudip Kar-GuptaOur Standards: The Thomson Reuters Trust Principles.

☆ Covid-19 Vaccine Rollout Carries Lessons for Pharma Supply Chains, Says Pfizer Executive
▼ + stars: | 2022-09-24 | by ( Liz Young | ) www.wsj.com time to read: +4 min

Newsletter Sign-up The Logistics Report Top news and in-depth analysis on the world of logistics, from supply chain to transport and technology. As the coronavirus rapidly spread across the U.S. in early 2020, Pfizer and Moderna each threw enormous resources behind the effort to perfect vaccines using novel technology that delivers mRNA, a type of genetic material. With the vaccine still under development, the company began designing its supply chain to rapidly scale up production and to start distribution of millions of doses once regulators approved the vaccine. Trucks carrying the first shipment of Pfizer’s Covid-19 vaccine in December 2020. Pfizer created a shipping container about the size of a suitcase that was packed with vaccine vials and dry ice to keep the doses effective for up to 10 days.

☆ 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.

☆ Less than 2% of U.S. adults have gotten updated Covid booster shots
▼ + stars: | 2022-09-23 | by ( Aria Bendix | Aria Bendix Is The Breaking Health Reporter For Nbc News Digital. | ) www.nbcnews.com time to read: +5 min

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.

☆ Moderna Covid-19 Booster Shortage Leads to Fewer Appointments at Pharmacies
▼ + stars: | 2022-09-23 | by ( Peter Loftus | ) www.wsj.com time to read: 1 min

Some U.S. pharmacies and other vaccine providers are offering the new Covid-19 booster shot only from Pfizer Inc. and BioNTech SE , after a manufacturing-quality problem at a contract manufacturer caused a shortage of Moderna Inc.’s new booster shot. In recent days, federal officials have advised state officials there is a limited supply of Moderna’s updated booster shots, said Marcus Plescia , chief medical officer of the Association of State and Territorial Health Officials.

☆ The mRNA vaccine transformed Pfizer. Here's how the biopharma giant plans to retain its new 'light-speed mentality' and create drugs faster.
▼ + stars: | 2022-09-23 | by ( Marguerite Ward | ) www.businessinsider.com time to read: +6 min

The biopharmaceutical giant, along with its partner BioNTech, was one of the first to develop a marketable vaccine for COVID-19 using nascent mRNA technology. mRNA technology has tremendous potential for other disease areas such as oncology and rare diseases. We've just started our phase-three study of a quadrant flu vaccine made out of mRNA. We see it has several advantages over current flu vaccines, including higher efficacy. A Pfizer senior vice president said mRNA technology could transform vaccines for the flu and lead to breakthroughs in cancer treatment.

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