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☆ Pfizer's combination Covid, flu vaccine will move to final-stage trial after positive data
▼ + stars: | 2023-10-26 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Pfizer on Thursday said its combination vaccine candidates targeting Covid and the flu will move to a final-stage trial in the coming months after showing positive initial results in an early to mid-stage study. Covid vaccine rates in the U.S. were bleak last year, and could look the same this year. The trial measured the safety, tolerability and efficacy of Pfizer's combination vaccine candidates among adults ages 18 to 64. The results showed that "lead" formulations of Pfizer's combination vaccine demonstrated robust immune responses to influenza A, influenza B and Covid strains, according to Pfizer. The safety profiles of the combination vaccine candidates were also consistent with the company's Covid vaccine.

Persons: BioNTech, Annaliesa Anderson, Pfizer's, Albert Bourla Organizations: Pfizer, BioNTech, Moderna Locations: U.S

☆ Pfizer RSV vaccine for older adults is only slightly less effective after 18 months
▼ + stars: | 2023-06-21 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

Pfizer 's vaccine that protects adults ages 60 and older from respiratory syncytial virus was slightly less effective after 18 months, according to clinical trial results the company announced Wednesday. The data is from New York-based Pfizer's clinical trial on more than 34,000 older adults over two RSV seasons, or 24 months. The vaccine was roughly 49% effective against the same condition with two or more symptoms after 18 months, according to Pfizer. Anderson said studies are ongoing, and so is research evaluating the shot's efficacy in older adults with weak immune systems. RSV kills 6,000 to 10,000 older adults and hospitalizes 60,000 to 160,000 of them every year, according to the CDC.

Persons: Pfizer's, It's, Annaliesa Anderson, Anderson, Pfizer hasn't Organizations: Pfizer, Northern, That's, Centers for Disease Control, and Drug Administration, GlaxoSmithKline, CNBC, CDC Locations: New York, U.S

Its peak sales forecast is of more than $2 billion annually together from the maternal vaccine and an RSV shot for older adults. The case highlights how equitable global access will require better advance planning by drugmakers, governments and health organizations, health officials say. "They could have tried sooner," said Erin Sparrow, WHO's technical officer for the RSV vaccine, referring to Pfizer. Pfizer has yet to take a number of steps needed to make the vaccine available in developing countries, according to global health officials and the company. She still expects it to be several years before the RSV vaccine is launched in lower-income countries.

☆ Pfizer ready to launch RSV vaccines for older adults, pregnant women in US, Europe
▼ + stars: | 2023-03-09 | by ( Maggie Fick | ) www.reuters.com time to read: +2 min

PUURS, Belgium March 9 (Reuters) - U.S. drugmaker Pfizer (PFE.N) is ready to launch its respiratory syncytial virus (RSV) vaccine for both older adults and pregnant women in the U.S. and Europe later this year, executives said on Thursday. Both Pfizer and British drugmaker GSK (GSK.L) have RSV vaccines they hope to launch in the U.S. and Europe this year, pending regulators’ approval. “We are anticipating approval in both the U.S. and Europe in time for rollout in the fall,” Kena Swanson, Pfizer's head of viral vaccines research & development, told a media briefing at the company's biggest manufacturing and packaging site globally. GSK told Reuters on Wednesday that it is also ready to launch its RSV vaccine for older adults in the U.S. this year without supply constraints. GSK last year voluntarily stopped its clinical trial of its own RSV vaccine on pregnant women and is currently only pursuing the use of its vaccine on older adults, a company spokesperson told Reuters on Thursday.

☆ FDA expected to decide on Pfizer RSV vaccine for older adults by May 2023
▼ + stars: | 2022-12-07 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The Food and Drug Administration is expected to decide by spring whether to approve Pfizer's vaccine to prevent respiratory syncytial virus, or RSV, in adults ages 60 and older. Pfizer, in a statement Wednesday, said the FDA has accepted its RSV vaccine candidate for review under an expedited process that reduces the approval process by four months. RSV is a common respiratory virus that causes cold like symptoms in most people, but it can result in severe illness in infants and older adults. Between 60,000 and 120,000 older adults are hospitalized with RSV every year and 6,000 to 10,000 older adults die from the virus. Pfizer's vaccine candidate was about 86% effective in preventing severe lower respiratory tract illness, defined as three or more symptoms.

☆ Pfizer RSV vaccine given to pregnant mothers is effective at protecting newborns, company's data shows
▼ + stars: | 2022-11-01 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Pfizer's vaccine against respiratory syncytial virus, or RSV, is highly effective at protecting newborns when the shot is given to the mothers late in their pregnancy, according to clinical trial data published Tuesday. RSV is a common respiratory virus that generally causes mild cold-like symptoms, but it can be dangerous for infants younger than 6 months. The vaccine was well tolerated with no safety concerns for the mothers or their newborns, according to Pfizer. Infants almost always show symptoms, but for babies younger than six months these symptoms can be more subtle, according to the CDC. Irritability, decreased activity and appetite, as well as pausing while breathing are all signs that an infant might have RSV, according to the CDC.

☆ New RSV vaccines may soon put an end to rough seasons
▼ + stars: | 2022-10-31 | by ( Brenda Goodman | ) edition.cnn.com time to read: +15 min

The monoclonal antibody, Synagis, is given monthly during RSV season to protect preemies and other high-risk babies. In the failed RSV vaccine trial, the chemical the researchers used to deactivate the virus denatured its proteins – essentially flattening them. Four companies have RSV vaccines for adults in the final phases of human trials: Pfizer and GSK are testing vaccines for pregnant women as well as seniors. Janssen, Pfizer and GSK each appear effective at preventing infections in adults for the first RSV season after the vaccine. The vaccines for pregnant women are meant to get newborns through their first RSV season.

☆ 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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