- Attorney General Ken Paxton Sues Pfizer for Misrepresenting COVID-19 Vaccine Efficacy and Conspiring to Censor Public Discourse Texas Attorney General (.gov)
- Texas Attorney General Ken Paxton sues Pfizer, alleges pharma giant lied about COVID vaccine efficacy Fox Business
- Texas AG Sues Pfizer, Alleging Company Made ‘Deceptive’ Claims about Covid-19 Vaccine Efficacy National Review
- Texas AG Paxton suing Pfizer for attempted censorship, ‘misrepresenting’ COVID-19 vaccination The Hill
- Texas Accuses Pfizer of Overstating Covid-19 Vaccine Effectiveness Bloomberg
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Tag Archives: Pfizer
Video shows tornado tearing through North Carolina and destroying the roof of a Pfizer plant – Daily Mail
- Video shows tornado tearing through North Carolina and destroying the roof of a Pfizer plant Daily Mail
- Tornado damage to North Carolina Pfizer plant unlikely to cause significant drug supply impacts, FDA says Fox Business
- Tornado damage to Pfizer plant won’t worsen drug shortage: FDA NewsNation Now
- NC tornado insurance | Couple let insurance lapse, month later an EF-3 tornado destroys their year old home in Nash County WTVD-TV
- WATCH: Pfizer CEO gives update on operations after tornado damages North Carolina plant PBS NewsHour
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Astellas, Pfizer look to broaden Xtandi’s patient base with new prostate cancer win after 8 years – FiercePharma
- Astellas, Pfizer look to broaden Xtandi’s patient base with new prostate cancer win after 8 years FiercePharma
- Pfizer and Astellas Seek Expanded Label for Expensive Prostate Cancer Drug BioSpace
- Enzalutamide plus leuprolide boosts metastasis-free survival in nmHSPC Urology Times
- Pfizer, Astellas’ Xtandi meets main goal in phase 3 trial for prostate cancer subtype Seeking Alpha
- Phase 3 Study Shows XTANDI® (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer PR Newswire
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Pfizer recalls 4.2M prescription drug packages due to risk of child poisonings – Fox Business
- Pfizer recalls 4.2M prescription drug packages due to risk of child poisonings Fox Business
- Pfizer and Biohaven recall 4.2M Nurtec units on packaging flaw FiercePharma
- Pfizer recalls millions of packs of migraine prescription drugs WGHP FOX8 Greensboro
- Recall alert: CDC announces recall of 4.2 million Nurtec ODT tablets due to packaging issues WPXI Pittsburgh
- Pfizer Recalls Nurtec ODT Prescription Drugs Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning Consumer Product Safety Commission
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U.S. CDC still looking at potential stroke risk from Pfizer bivalent COVID shot
Jan 26 (Reuters) – New data from one U.S. Centers for Disease Control and Prevention (CDC) database shows a possible stroke risk link for older adults who received an updated Pfizer (PFE.N)/BioNTech (22UAy.DE) COVID-19 booster shot, but the signal is weaker than what the agency had flagged earlier in January, health officials said on Thursday.
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.
Earlier this month, U.S. health officials said they had detected the possible link to ischemic strokes in people over age 65 who received the newer booster shots in its Vaccine Safety Datalink (VSD) database. They said at the time it was very unlikely to represent a true clinical risk.
Dr. Nicola Klein of healthcare company Kaiser Permanente, which maintains VSD data for the CDC, said the rate of strokes observed in the database had slowed in recent weeks, but the signal was still statistically significant, meaning likely not by chance.
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.
Dr. Walid Gellad, professor of medicine at University of Pittsburgh, said the issue required further investigation.
“Sometimes signals are not clear,” Gellad said in an email. “It makes sense to look into it more, and it doesn’t make sense to change practice given the known benefits (of getting the booster) in this age group.”
(This story has been corrected to fix the name to Nicola from Nicole in paragraph 5)
Reporting by Michael Erman; Editing by Bill Berkrot
Our Standards: The Thomson Reuters Trust Principles.
Rubio Sends Letter to Pfizer CEO on Alleged Gain-of-Function Research – Press Releases
An investigative report suggests that Pfizer may be conducting gain-of-function research, which it dubs “directed evolution” research to mutate the SARS-CoV-2 virus to create additional, more potent variants and vaccines to combat future variants. This type of research, similar to gain-of-function research, has long been controversial, and is suspected to be the cause of the COVID-19 pandemic.
U.S. Senator Marco Rubio (R-FL) sent a letter to Albert Bourla, the President and CEO of Pfizer, following the release of a video showing Pfizer’s director of research and development casually discussing the company’s manipulation of the SARS-Cov-2 virus for company profit.
- “Whether it’s gain of function research, or selected structure mutations through directed evolution, as Mr. Walker claimed would occur, any effort to make a virus more transmittable and deadlier is careless and dangerous. Further, Mr. Walker stated that Pfizer is willing to engage in this dangerous research because COVID and its variants are ‘a cash cow’ for the company and regulators will go easy on their efforts because a significant percentage of government officials aim to work for Pfizer and other biopharmaceutical companies and do not want to compromise their future job prospects.” — Senator Rubio
Want more information? The full text of the letter is below.
Dear Dr. Bourla:
I write in response to troubling reports on Pfizer’s intention to mutate the SARS-CoV-2 (COVID) virus through gain-of-function, or “directed evolution,” as detailed by Pfizer Director of Research and Development, Jordan Walker. As has been proven time and time again, attempts to mutate a virus, particularly one as potent as COVID, are dangerous. If the claims detailed in the video are true, Pfizer has put its desire for profit over the concern of national and global health and must hold itself accountable.
In a video released by Project Veritas on January 25, 2023, Mr. Walker laid out Pfizer’s plans to develop new vaccines for future variants of COVID by mutating the virus through directed evolution, a process that uses protein engineering to impose natural selection on a living organism or other biological materials, including viruses. Though he claimed the research is currently “exploratory,” he detailed how the research would proceed, such as how scientists would inject the mutated viruses into monkeys and collect serial samples from other monkeys who are infected.
Whether it’s gain of function research, or selected structure mutations through directed evolution, as Mr. Walker claimed would occur, any effort to make a virus more transmittable and deadlier is careless and dangerous. Further, Mr. Walker stated that Pfizer is willing to engage in this dangerous research because COVID and its variants are “a cash cow” for the company and regulators will go easy on their efforts because a significant percentage of government officials aim to work for Pfizer and other biopharmaceutical companies and do not want to compromise their future job prospects.
As a company that claims to “innovate every day to make the world a healthier place,” these claims from your leadership charged with research and development are alarming. As the American people deserve to know, I request that you provide the following information:
1. What efforts is Pfizer currently, or planning to, engage in to mutate the SARS-CoV-2 virus?
2. Does Pfizer intend to continue mutating the SARS-CoV-2 virus through gain-of-function, or directed evolution research, with the purpose of creating new vaccines before the variant is present in the greater population?
3. Has Pfizer engaged with federal officials engaged regarding their plans to oversee this research? Please provide the names and agencies for these individuals.
4. What steps has Pfizer taken to ensure the mutated virus does not leak from the laboratory and infect the greater population?
5. Has Pfizer engaged with other biopharmaceutical companies to collaborate on this research effort? Please list the entities that you have been in contact with.
6. Will you commit to halting any future research that mutates the SARS-CoV-2 vaccine as substantial evidence has indicated that similar dangerous research at the Wuhan Institute of Virology very likely led to the initial emergence and global spread of the virus?
As a leader in global public health and development of the COVID vaccine, with American taxpayer dollars, it is critical that Pfizer is accountable for their actions and be transparent with the public on the substance and intent of their research.
Thank you for your attention to this matter. I look forward to your prompt response.
U.S. CDC still looking at potential stroke risk from Pfizer bivalent COVID shot
By Michael Erman
(Reuters) – New data from one U.S. Centers for Disease Control and Prevention (CDC) database shows a possible stroke risk link for older adults who received an updated Pfizer/BioNTech COVID-19 booster shot, but the signal is weaker than what the agency had flagged earlier in January, health officials said on Thursday.
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.
Earlier this month, U.S. health officials said they had detected the possible link to ischemic strokes in people over age 65 who received the newer booster shots in its Vaccine Safety Datalink (VSD) database. They said at the time it was very unlikely to represent a true clinical risk.
Dr. Nicole Klein of healthcare company Kaiser Permanente, which maintains VSD data for the CDC, said the rate of strokes observed in the database had slowed in recent weeks, but the signal was still statistically significant, meaning likely not by chance.
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.
Dr. Walid Gellad, professor of medicine at University of Pittsburgh, said the issue required further investigation.
“Sometimes signals are not clear,” Gellad said in an email. “It makes sense to look into it more, and it doesn’t make sense to change practice given the known benefits (of getting the booster) in this age group.”
(Reporting by Michael Erman; Editing by Bill Berkrot)
Covid vaccines may make BOTOX wear off faster, study suggests
Bad news for Instagram models and aging Hollywood celebrities — Covid vaccines may make Botox wear off quicker.
An Israeli study claims that Botox injections used to minimize forehead and crow’s feet lines ‘might be less effective after Covid-19 vaccination’.
Researchers found the average time that it took patients to need a top-up of the wrinkle-smoother shortened after they received the Pfizer mRNA vaccine.
Patients who previously returned every 118 days between injections were coming in around 20 days earlier. But doctors stressed it was not a reason not to get the vaccine.
Findings from an Israeli study indicate that the Pfizer vaccine may make Botox injections less effective, with regular Botox patients coming in around two to three weeks earlier for top-ups after receiving the vax
Dermatologists in the US are reportedly seeing a similar trend among Botox users.
New York dermatologist Dr. Marisa Garshick addressed the topic in an Instagram reel last week.
‘Is the COVID vaccine why your Botox isn’t lasting as long?’ she asks in the short video, before flashing an image of the study.
In the accompanying caption, Dr. Garshick clarified that while some dermatologists – and patients – may have noticed this phenomenon in the office, ‘more research is needed to truly understand this observation’.
She also made sure to caveat that the potential cosmetic side-effect is not a reason to not get vaccinated.
Commenting on the post, popular skincare influencer Susan Yara said she too had experienced the quicker dissolving of her filler.
‘UGH!! I didn’t want this to be true, but it happened to me. I switched to Xeomin and it made a big difference’, she wrote beneath the video.
Injections generally last four to six months before a top-up is required to ensure a smooth complexion.
Botox is a brand name of botulinum toxin injectables.
They are injectable chemical class known as neuromodulators that interrupt signals between nerves and muscles to make them relax.
As a result, visible wrinkles will disappear.
These neuromodulators are typically used to treat the areas of the face between the eyebrows and in the corners of the eyes, as well as sometimes to plump the upper lip in a procedure called a ‘lip flip’.
The study looked at botulinum toxin injectables more generally – not just the popular Botox but also other newer neuromodulator treatments like Dysport, Xeomin, and Jeuveau.
Published in the Journal of Cosmetic Dermatology, the paper focused on 45 subjects, 89 percent female, with an average age of 48.3.
Because of the relatively small sample size, researchers clarified that their findings are inconclusive and called for additional research into the subject.
However, their results showed a marked decrease in the time it took patients to return to clinics needing Botulinum type A (BTA) top-up injections.
It can be assumed that the shortening of this interval between treatments mirrors ‘a reduction in the effectiveness of BTA’ following the vaccine, researchers explained.
The study did not determine exactly why the shot would have an effect on someone’s Botox.
But researchers speculate that the immune response created by the shot could see the injected substance as a foreign substance in the body and attack it.
In turn, the effects of Botox quickly wear off as antibodies in the blood stream fight it off.
It also did not clarify whether contracting the Covid virus itself had a similar impact on Botox longevity.
Questions over the impact of the mRNA jab on patients with filler – substances injected into the skin to add volume and fullness – were raised early on during the vaccine rollout after the FDA reported two people developing facial swelling after vaccination, both with prior histories of cosmetic filler injections.
On both, the swelling was localized to where filler was injected but went down with anti-histamines and steroid cream.
Doctors at the time claimed the reaction was most likely the result of the immune system revving up in the wake of the vaccine – a similar explanation to that put forward by the recent Botox-focused study.
None of these side effects imply the Covid vaccine is unsafe, however, as many dermatologists are clear to clarify.
If patients are worried about their Botox not working as well post-jab, other types of BTA treatments are available and potentially more effective.
Likewise, people can also develop a natural resistance to Botox over time, regardless of whether they’ve received the vax.
In short, as most would hopefully agree, a forehead line or two is worth avoiding a potentially deadly virus.
Pfizer CEO says there will be no generic Paxlovid for China
An online pharmacy lists Pfizer’s oral anti-Covid drug Paxlovid for 2,980 yuan per box in in Suqian, Jiangsu province, China on Dec. 13, 2022.
CFOTO | Future Publishing | Getty Images
Pfizer is not in talks with Chinese authorities to license a generic version of its Covid-19 treatment Paxlovid for use there, but is in discussions about a price for the branded product, Chief Executive Albert Bourla said on Monday.
Reuters reported on Friday that China was in talks with Pfizer to secure a license that will allow domestic drugmakers to manufacture and distribute a generic version of the U.S. firm’s Covid-19 antiviral drug Paxlovid in China.
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Referring to that report, Bourla speaking at JPMorgan’s healthcare conference in San Francisco, said “We are not in discussions. We have an agreement already for local manufacturing of Paxlovid in China. So we have a local partner that will make Paxlovid for us, and then we will sell it to the Chinese market.”
Bourla said the company had shipped thousands of courses of the treatment in 2022 to China and in the past couple of weeks, had increased that to millions.
On Sunday, China’s Healthcare Security Administration (NHSA) said that the country would not include Paxlovid in an update to its list of medicines covered by basic medical insurance schemes as the U.S. firm quoted a high price for the Covid-19 drug.
Bourla said that talks with China on future pricing for the treatment had broken off after China had asked for a lower price than Pfizer is charging for most lower middle income countries.
“They are the second highest economy in the world and I don’t think that they should pay less than El Salvador,” Bourla said.
Still, Bourla said the removal from the list would not have an effect on the company’s business there until April. He said the company had shipped millions of courses of the drug to China in recent weeks.
The company could end up selling only to the private market in China, he said.
Beijing to distribute Pfizer antiviral drug as Covid wave overwhelms health system
Beijing
CNN
—
Beijing will begin distributing Pfizer’s Covid-19 drug Paxlovid to the city’s community health centers in the coming days, state media reported Monday.
The report comes as the city grapples with an unprecedented wave of infections that has severely strained its hospitals and emptied pharmacy shelves.
The state-run China News Service reported Monday that after receiving training, community doctors will administer the medicine to Covid-19 patients and give instructions on how to use them.
“We have received the notice from officials, but it is not clear when the drugs will arrive,” it cited a worker at a local community health center in Beijing’s Xicheng district as saying.
Paxlovid remains the only foreign medicine to treat Covid that has been approved by China’s regulator for nationwide use, but access is extremely difficult to come by. When a Chinese healthcare platform offered the antiviral drug earlier this month, it sold out within hours.
Azvudine, an oral medicine developed by China’s Genuine Biotech, has also been approved.
After nearly three years of lockdowns, quarantines and mass testing, China abruptly abandoned its zero-Covid policy this month following nationwide protests over its heavy economic and social toll.
The abrupt change in policy has sparked panic buying of fever and cold medicines, leading to widespread shortages, both at pharmacies and on online shopping platforms. Long lines have become routine outside fever clinics and hospital wards overflowing with patients in the capital Beijing and elsewhere in the country.
On Monday, Chinese state media CCTV quoted President Xi Jinping as saying the country needed a more targeted health strategy to protect people’s lives as the Covid situation in China changes.
“Xi Jinping emphasized that our country is currently facing a new Covid outbreak situation and new responsibilities, we need to conduct our patriotic health movement in a more targeted manner,” the CCTV report said.
It was one of the first public statements made by Xi about China’s Covid situation since the government’s decision to ease its strict restrictions.
An emergency room doctor in Beijing told the state-run People’s Daily on Thursday that four doctors on his shift did not have time to eat or drink. “We have been seeing patients nonstop,” he said.
Another emergency room doctor told the newspaper he had been working despite having developed fever symptoms. “The number of patients is high, and with fewer medical staff, the pressure is multiplied,” said the doctor.
In a sign of the strain on Beijing’s medical system, hundreds of health professionals from across China have traveled to the city to assist medical centers.
As the capital, Beijing has some of the best medical resources in the country. However, the abrupt zero-Covid u-turn has left people and health facilities ill-prepared to deal with a surge in infections.
China’s official Covid case count has become meaningless after it rolled back mass testing and allowed residents to use antigen tests and isolate at home. It has stopped reporting asymptomatic cases, conceding it was no longer possible to track the actual number of infections.
According to an internal estimate from the National Health Commission, almost 250 million people in China have caught Covid in the first 20 days of December – accounting for roughly 18% of the country’s population.
Experts have warned that as people in big cities return to their hometowns for the Lunar New Year next month, the virus could sweep through China’s vast rural areas, where vaccination rates are lower and medical resources are severely lacking.