Latest news with #PfizerBioNTech
News.com.au
2 days ago
- Health
- News.com.au
‘Dark spots': COVID jab tied to rare health symptom
New research is calling for further study on a possible link between COVID-19 jabs and long-term vision issues. While vaccines have been vital in fighting the pandemic, emerging data could mean we're not out of the woods yet. Between January 2021 and January 2023, 20 peer-reviewed studies looked into eye problems reported by 243 people aged 18 to 84 who had received COVID-19 vaccines. Almost half of these patients - 42 per cent - had the Pfizer-BioNTech jab, which was the main vaccine rolled out in Australia, the USA, the UK, and much of Europe. What jumps out is inflammation. Nearly half of the patients reported experiencing ocular inflammatory conditions like uveitis, an irritation deep inside the eye. Another 24 per cent were said to have suffered optic neuritis, a swelling of the optic nerve that can cause pain and threaten vision. Herpetic eye disease, caused by the herpes virus attacking the eye, showed up in 14 per cent of cases, triggering redness, pain, and discomfort. About 10 per cent documented retinal circulation issues - blockages in the eye's arteries or veins that can trigger sudden vision loss. And there were also a few rare cases where patients were noted to exhibit retina-related problems causing 'dark spots' or 'blind patches'. But the most notable observations come from a recent Turkish study that tracked 64 patients before and after their two mRNA vaccine doses. Using detailed eye scans, researchers found an 8 per cent drop in the cornea's endothelial cell count - the cells responsible for keeping the cornea clear. These cells don't regenerate, and losing too many can permanently impair vision. To put that into perspective, healthy adults usually have between 2000 and 3000 of these cells per square millimetre. After vaccination, the average dropped from 2597 to 2378. While these numbers are still considered safe for most, the decline could be a warning sign for people with pre-existing eye conditions or those who have had eye surgeries like LASIK, cataract removal, or corneal transplants. Researchers also noted that corneas thickened by around 2 per cent after vaccination - a sign of possible swelling. The honeycomb shape of the endothelial cells became distorted, and the size differences between individual cells increased, which are both signs of cellular stress. Though none of the study participants reported immediate vision problems, experts warn that long-term structural changes to the cornea could lead to lasting damage, especially in vulnerable patients. Dr Fatma Sümer and Sevgi SubaÅŸi, authors of the study published in Ophthalmic Epidemiology, stressed the need for careful observation: 'The endothelium should be closely monitored in those with a low endothelial count or who have had a corneal graft.' According to Healthline, eye complications after vaccination are rare and appear to be driven by an overactive immune response. Symptoms can include blurred vision, light sensitivity, redness, eye pain, shingles around the eye, or reactivated herpes infections. In even rarer cases, the immune system may reject a previously transplanted cornea, risking vision loss and graft failure. This means the transplanted cornea loses its clarity and function, leading to impaired vision and the potential need for further treatment or surgery. These findings are not conclusive, and experts do not advise people to skip their COVID vaccine shots — far from it. But they are urging doctors and patients to not ignore these subtle warning signs. Those who have had prior eye surgery, suffer from chronic eye disease, or notice persistent blurry vision after vaccination are advised to be checked, because even small changes inside your eyes can have big consequences down the road According to safety reports from the Therapeutic Goods Administration (TGA), 'vaccination is the most effective way to reduce deaths and severe illness from infection.' Like all medicines, the TGA notes, 'COVID-19 vaccines may cause some side effects. 'The most frequently reported include injection-site reactions (such as a sore arm) and more general symptoms, like headache, muscle pain, fever and chills.' The TGA closely monitors reports of adverse events to the COVID-19 vaccines and emphasises that 'the protective benefits of vaccination far outweigh the potential risks.'
Yahoo
18-05-2025
- Health
- Yahoo
RFK Jr's FDA limits use of Covid vaccine
The Food and Drug Administration, now under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr., has severely restricted the use of the NovavaxCOVID-19 vaccine. The vaccine will now only be available to high-risk individuals and will not be administered to those who may need it to protect others. Kennedy's FDA approved the use of the Novavax Covid-19 vaccine, but with strict conditions. It will only be made available to older people and those over the age of 12 with at least one medical condition that leaves them at high risk from Covid, The New York Times reported. Centers for Disease Control and Prevention advisers have been discussing whether to recommend the vaccine only for those most at risk. The new restrictions mean that healthy people over the age of 65 won't be able to get the Novavax vaccine, even if they have an immunocompromised friend or family member. Critics have slammed the restrictions for being in line with Kennedy's vaccine skepticism. The secretary has ordered an investigation into the debunked claim that vaccines cause autism. The Novavax vaccine was previously only allowed to be used in emergencies. Meanwhile, the FDA gave full approval to vaccines by Pfizer-BioNTech and Moderna in 2022 under the Biden administration. Both companies are producing updated versions of their vaccines for the fall. Former CDC adviser and Massachusetts General Hospital infectious disease physician Dr Camille Kotton told The Times that the new restrictions were 'incredibly disappointing.' 'I don't know why they would make this restriction; I don't know of any indication to make this change,' she added. She noted that many people are still sent to hospital and dying because of Covid-19. She called it 'a dark day in American medicine.' The vaccine's approval requires the company to finish studies into whether it is connected to several heart conditions. However, some of the necessary research can be done with existing data. However, The Times reported that one of the new studies would force the company to follow thousands of people between the ages of 50 and 65, a study that may cost tens of millions of dollars. Dr. Ofer Levy of Boston Children's Hospital, where he directs the precision vaccine program, is a vaccine adviser to the FDA. 'We've got to make sure the vaccine safety is crystal clear to engender public confidence,' Levy noted. 'On the other hand, where's that line where you put in too much regulation, it starts to become so challenging that the economics of even making a vaccine are called into question?' 'I don't pretend to know the answer,' Levy added. Dr. Paul Offit is a vaccine expert at the Children's Hospital of Philadelphia. 'I think the goal of Robert F. Kennedy Jr. is to make vaccines less available, more expensive, and more feared,' he told the paper. 'His goal is to tear away at the vaccine infrastructure, because he believes that vaccines are not beneficial and are only harmful.'
The Independent
18-05-2025
- Health
- The Independent
RFK Jr's FDA limits use of Covid vaccine
The Food and Drug Administration, now under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr., has severely restricted the use of the Novavax COVID-19 vaccine. The vaccine will now only be available to high-risk individuals and will not be administered to those who may need it to protect others. Kennedy's FDA approved the use of the Novavax Covid-19 vaccine, but with strict conditions. It will only be made available to older people and those over the age of 12 with at least one medical condition that leaves them at high risk from Covid, The New York Times reported. Centers for Disease Control and Prevention advisers have been discussing whether to recommend the vaccine only for those most at risk. The new restrictions mean that healthy people over the age of 65 won't be able to get the Novavax vaccine, even if they have an immunocompromised friend or family member. Critics have slammed the restrictions for being in line with Kennedy's vaccine skepticism. The secretary has ordered an investigation into the debunked claim that vaccines cause autism. The Novavax vaccine was previously only allowed to be used in emergencies. Meanwhile, the FDA gave full approval to vaccines by Pfizer-BioNTech and Moderna in 2022 under the Biden administration. Both companies are producing updated versions of their vaccines for the fall. Former CDC adviser and Massachusetts General Hospital infectious disease physician Dr Camille Kotton told The Times that the new restrictions were 'incredibly disappointing.' 'I don't know why they would make this restriction; I don't know of any indication to make this change,' she added. She noted that many people are still sent to hospital and dying because of Covid-19. She called it 'a dark day in American medicine.' The vaccine's approval requires the company to finish studies into whether it is connected to several heart conditions. However, some of the necessary research can be done with existing data. However, The Times reported that one of the new studies would force the company to follow thousands of people between the ages of 50 and 65, a study that may cost tens of millions of dollars. Dr. Ofer Levy of Boston Children's Hospital, where he directs the precision vaccine program, is a vaccine adviser to the FDA. 'We've got to make sure the vaccine safety is crystal clear to engender public confidence,' Levy noted. 'On the other hand, where's that line where you put in too much regulation, it starts to become so challenging that the economics of even making a vaccine are called into question?' 'I don't pretend to know the answer,' Levy added. Dr. Paul Offit is a vaccine expert at the Children's Hospital of Philadelphia. 'I think the goal of Robert F. Kennedy Jr. is to make vaccines less available, more expensive, and more feared,' he told the paper. 'His goal is to tear away at the vaccine infrastructure, because he believes that vaccines are not beneficial and are only harmful.'
New York Times
17-05-2025
- Health
- New York Times
F.D.A. Approves Novavax Covid Vaccine With Stricter New Conditions
The Food and Drug Administration on Friday approved the Novavax Covid-19 vaccine, but only for older adults and for others over age 12 who have at least one medical condition that puts them at high risk from Covid. Scientific advisers to the Centers for Disease Control and Prevention, who typically make decisions on who should get approved shots and when, have been debating whether to recommend Covid shots only to the most vulnerable Americans. The F.D.A.'s decision appeared to render at least part of their discussion moot. The new restriction will limit access to the Novavax vaccine for people under 65 who are in good health. It may leave Americans who do not have underlying conditions at risk if a more virulent version of the coronavirus were to emerge. It could also limit options for people who want the vaccine for a wide array of reasons, including to protect a vulnerable loved one. The vaccine had previously been authorized under emergency use. Covid vaccines developed by Pfizer-BioNTech and Moderna, which are more widely used by Americans, were granted full approval in 2022. However, the companies are working on updated shots for the fall, and the new restrictions on the Novavax shot portend a more restrictive approach from the F.D.A. The F.D.A.'s new restrictions also appeared to reflect the high degree of skepticism about vaccines from Robert F. Kennedy Jr., the health secretary, and the other leaders he has appointed at health agencies. 'This is incredibly disappointing,' said Dr. Camille Kotton, an infectious disease physician at Massachusetts General Hospital who cares for immunocompromised patients, and a former adviser to the C.D.C. 'I don't know why they would make this restriction; I don't know of any indication to make this change,' Dr. Kotton said, adding that many people are still hospitalized and dying as a result of Covid. 'This is a dark day in American medicine.' The approval of the shot, called Nuvaxovid, requires the company to complete studies on whether the vaccine is associated with several heart conditions. Some of the required research is possible to complete with available data. But one new study would most likely require the company to follow thousands of healthy people who are 50 to 65 years old who take either the vaccine or a placebo. That study could cost tens of millions of dollars, at least, according to people familiar with such work. 'We've got to make sure the vaccine safety is crystal clear to engender public confidence,' said Dr. Ofer Levy, director of the precision vaccine program at Boston Children's Hospital and an adviser to the F.D.A. on vaccines. 'On the other hand, where's that line where you put in too much regulation, it starts to become so challenging that the economics of even making a vaccine are called into question?' Dr. Levy said. 'I don't pretend to know the answer.' The F.D.A. said that a study of the Novavax shot in people younger than 12 is C. Jacobs, the Novavax chief executive, said the approval was a 'significant milestone' solidifying a pathway for the people who are most likely to seek out Covid vaccination to get the company's shot. The new restrictions on the shot could create a raft of problems for those who want the vaccine. For one, the approval document is unclear about what qualifies as an underlying condition. Prescribing the shots in healthy people under 65 would be considered off-label use, making it less likely that insurers would broadly cover the shots. 'I think we're left confused about what this means for the consumer,' said Dr. Paul Offit, a vaccine expert from Children's Hospital of Philadelphia and an adviser to the F.D.A. 'I think the goal of Robert F. Kennedy Jr. is to make vaccines less available, more expensive and more feared,' Dr. Offit said. 'His goal is to tear away at the vaccine infrastructure, because he believes that vaccines are not beneficial and are only harmful.' Approval of the Novavax Covid shot also bucks norms that have been in place since the vaccines were first approved. This is the first time that the F.D.A. has included health criteria for Covid shots. Those decisions are typically made by the C.D.C.'s advisers. Insurance carriers are required to cover vaccines recommended by the advisers, but the panel usually cannot expand the vaccine's use beyond the bounds of the F.D.A. approval. Novavax's Covid shot was the last to become available during the pandemic because of unexpected manufacturing problems. It has been offered under emergency authorization since July 2022. On Thursday, Dr. Marty Makary, who leads the F.D.A., said the agency would soon release a new framework for evaluating Covid shots. A meeting is scheduled for this coming Thursday to select the version of the virus that the fall Covid shots will cover. Nuvaxovid is based on a more traditional vaccine platform, and is generally thought to have fewer side effects. It has served as an attractive alternative for those who are wary of the newer technology used in the mRNA vaccines made by Pfizer-BioNTech and Moderna. 'I have been recommending this vaccine for everyone who is mRNA-vaccine reluctant,' Dr. Kotton said. She said she and her two sons all opted for Novavax last fall, but none of them would qualify under the new criteria.
