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IOL News
an hour ago
- Health
- IOL News
New US report reveals myocarditis risks linked to Covid vaccines for South Africans
A damning new report by US Senator Ron Johnson reveals that American authorities were alerted to a potential link between the Pfizer and Moderna vaccines and conditions like myocarditis and pericarditis as early as February 2021, yet delayed warning the public for months. Image: Pexels As the world scrambled to roll out Covid-19 vaccines in 2021, millions of South Africans received mRNA jabs with confidence — unaware that top US health officials were sitting on growing concerns about serious heart-related side effects. A damning new report by US Senator Ron Johnson reveals that American authorities were alerted to a potential link between the Pfizer and Moderna vaccines and conditions like myocarditis and pericarditis as early as February 2021, yet delayed warning the public for months. Implications for South Africa Now, as South Africans report similar complications, questions are being raised about whether local authorities were also kept in the dark — and what that has meant for informed consent. As many South Africans continue to report post-vaccine complications, the findings have reignited concerns around the adequacy of information provided to the public during the country's rollout. For those who experienced symptoms like heart inflammation, the silence from health authorities now feels like a betrayal. According to the 54-page interim report, the US Centres for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) were aware of 'large reports of myocarditis' among young vaccine recipients, but only moved to update the vaccine safety labels in late June 2021. This means millions of people across the globe — including in South Africa — received mRNA shots without being informed of these potential risks. 'Even though CDC and FDA officials were well aware of the risk of myocarditis following Covid-19 vaccination, the US administration opted to withhold issuing a formal warning to the public for months about the safety concerns,' the report states. Video Player is loading. Play Video Play Unmute Current Time 0:00 / Duration -:- Loaded : 0% Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Transparency Opaque Semi-Transparent Background Color Black White Red Green Blue Yellow Magenta Cyan Transparency Opaque Semi-Transparent Transparent Window Color Black White Red Green Blue Yellow Magenta Cyan Transparency Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Dropshadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. Advertisement Next Stay Close ✕ Ad loading What is Myocarditis? Myocarditis, an inflammation of the heart muscle, and pericarditis, inflammation of the sac around the heart, can cause chest pain, irregular heart rhythms, and in rare cases, long-term cardiac damage. Myopericarditis, a combination of both, has also been reported. While these side effects are rare, they appear more frequently in young males and often emerge shortly after the second dose of the vaccine. South Africa relied heavily on Pfizer's mRNA vaccine during its national rollout. The US report raises concerns about whether international partners like South Africa received the necessary data to make timely and transparent decisions about public health messaging. If US authorities withheld warnings, were local health departments in a position to issue appropriate guidance — or were they operating under incomplete information? One pivotal moment came on 28 February 2021, when an Israeli health official contacted the CDC and FDA to flag 40 cases of post-vaccination myocarditis in young people. Despite the warning and Israel's significantly higher vaccination rate at the time, the US chose not to act publicly for several more months. During this silence, frontline doctors who attempted to raise red flags about the potential risks were reportedly censored or discredited. 'Around the time of internal CDC deliberations over myocarditis,' Senator Johnson writes, 'his office received a growing number of letters from doctors and other healthcare professionals who experienced suppression and censoring of this information they were experiencing.' Eventually, on June 25, 2021, the FDA added warnings to the Pfizer and Moderna labels about the risk of myocarditis and pericarditis. But by then, millions of people — including many South Africans — had already been vaccinated without that knowledge. The report's release comes just a day after the FDA announced tighter requirements for booster shot administration, adding further fuel to the debate about transparency, trust, and accountability in the global vaccine effort. IOL Lifestyle Get your news on the go, click here to join the IOL News WhatsApp channel.
Business Recorder
2 hours ago
- Health
- Business Recorder
US FDA approves Moderna's next-generation COVID vaccine for adults 65 or older
The U.S. Food and Drug Administration has approved Moderna's next-generation COVID-19 vaccine for everyone aged 65 and above, the company said on Saturday, the first endorsement since the regulator tightened requirements. The vaccine has also been approved for people aged 12 to 64 with at least one or more underlying risk factors defined by the Centers for Disease Control and Prevention, Moderna said in a statement. The company said it expects to have the vaccine, called mNEXSPIKE, available for the 2025-2026 respiratory virus season. 'The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,' CEO Stephane Bancel said in the statement. The Department of Health and Human Services, under the leadership of long-time vaccine skeptic Robert F. Kennedy Jr., is tightening regulatory scrutiny on vaccines. The FDA said on May 20 it planned to require drugmakers to test their COVID booster shots against an inert placebo in healthy adults under 65 for approval, effectively limiting them to older adults and those at risk of developing severe illness. The Moderna vaccine can be stored in refrigerators rather than freezers, to offer longer shelf life and make distribution easier, especially in developing countries where supply-chain issues could hamper vaccination drives. The Centers for Disease Control and Prevention, which Kennedy also oversees, said on Thursday that COVID vaccines remain an option for healthy children when parents and doctors agree that it is needed, stopping short of Kennedy's announcement days earlier that the agency would remove the shots from its immunization schedule. The CDC announcement eases investor concern to some extent, analysts say, as it keeps the existing framework for older adults and at-risk people who generally seek out the shots. FDA leaders have said 100 million to 200 million Americans would still be eligible for annual shots. Moderna is betting on its newer messenger RNA vaccines as it grapples with waning demand for its original COVID vaccine Spikevax and lower-than-expected uptake of its respiratory syncytial virus vaccine. The approval for mNEXSPIKE was based on late-stage trial data, which showed the shot was not inferior in efficacy compared to Spikevax in individuals aged 12 years and older. The shot also showed superior efficacy compared to Spikevax in adults 18 years of age and older in the study. Kennedy has kickstarted a major overhaul of health departments, laying off thousands of employees to align with President Donald Trump's goal of dramatically shrinking the federal government. This has further ignited worries about potential disruptions to the regulatory review of treatments and vaccines. The CDC's outside panel of vaccine experts in April discussed recommending the booster shots only for populations at risk of severe COVID-19 for the upcoming immunization campaign. The FDA approved Novavax's COVID vaccine Nuvaxovid this month, limiting its use to older adults and people over the age of 12 with conditions that put them at risk due to the illness. Conditions that constitute additional risk range from illnesses such as diabetes and heart disease to behaviors like physical inactivity and substance abuse, according to the CDC. While Moderna's shots, as well as Pfizer-BioNTech's Comirnaty, are mRNA-based, Novavax's vaccine is protein-based and takes longer to manufacture. Moderna this month withdrew an application seeking approval for its flu-and-COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot.
New York Post
3 hours ago
- Health
- New York Post
FDA approves Moderna's next-generation COVID vaccine for adults 65 or older
The US Food and Drug Administration has approved Moderna's next-generation COVID-19 vaccine for everyone aged 65 and above, the company said on Saturday, the first endorsement since the regulator tightened requirements. The vaccine has also been approved for people aged 12 to 64 with at least one or more underlying risk factors defined by the Centers for Disease Control and Prevention, Moderna said in a statement. The company said it expects to have the vaccine, called mNEXSPIKE, available for the 2025-2026 respiratory virus season. Advertisement 4 The FDA has approved Moderna's next-generation COVID-19 vaccine for people older than 65. REUTERS 'The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,' CEO Stephane Bancel said in the statement. The Department of Health and Human Services, under the leadership of long-time vaccine skeptic Robert F. Kennedy Jr., is tightening regulatory scrutiny on vaccines. Advertisement The FDA said on May 20 it planned to require drugmakers to test their COVID booster shots against an inert placebo in healthy adults under 65 for approval, effectively limiting them to older adults and those at risk of developing severe illness. The Moderna vaccine can be stored in refrigerators rather than freezers, to offer longer shelf life and make distribution easier, especially in developing countries where supply-chain issues could hamper vaccination drives. The Centers for Disease Control and Prevention, which Kennedy also oversees, said on Thursday that COVID vaccines remain an option for healthy children when parents and doctors agree that it is needed, stopping short of Kennedy's announcement days earlier that the agency would remove the shots from its immunization schedule. The CDC announcement eases investor concern to some extent, analysts say, as it keeps the existing framework for older adults and at-risk people who generally seek out the shots. Advertisement 4 The FDA said on May 20 it planned to require drugmakers to test their COVID booster shots against an inert placebo in healthy adults under 65 for approval. REUTERS FDA leaders have said 100 million to 200 million Americans would still be eligible for annual shots. Moderna is betting on its newer messenger RNA vaccines as it grapples with waning demand for its original COVID vaccine Spikevax and lower-than-expected uptake of its respiratory syncytial virus vaccine. The approval for mNEXSPIKE was based on late-stage trial data, which showed the shot was not inferior in efficacy compared to Spikevax in individuals aged 12 years and older. Advertisement 4 Department of Health and Human Services secretary Robert F. Kennedy Jr. is tightening regulatory scrutiny on vaccines. Getty Images The shot also showed superior efficacy compared to Spikevax in adults 18 years of age and older in the study. Kennedy has kickstarted a major overhaul of health departments, laying off thousands of employees to align with President Donald Trump's goal of dramatically shrinking the federal government. This has further ignited worries about potential disruptions to the regulatory review of treatments and vaccines. 4 Moderna's COVID-19 shots are mRNA-based. dpa/picture alliance via Getty Images The CDC's outside panel of vaccine experts in April discussed recommending the booster shots only for populations at risk of severe COVID-19 for the upcoming immunization campaign. The FDA approved Novavax's COVID vaccine Nuvaxovid this month, limiting its use to older adults and people over the age of 12 with conditions that put them at risk due to the illness. Conditions that constitute additional risk range from illnesses such as diabetes and heart disease to behaviors like physical inactivity and substance abuse, according to the CDC. Advertisement While Moderna's shots, as well as Pfizer-BioNTech's Comirnaty, are mRNA-based, Novavax's vaccine is protein-based and takes longer to manufacture. Moderna this month withdrew an application seeking approval for its flu-and-COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot.
Deccan Herald
4 hours ago
- Health
- Deccan Herald
US FDA approves Moderna's next-generation COVID vaccine for adults 65 or older
Moderna said it expects to have the vaccine, called mNEXSPIKE, available for the 2025-2026 respiratory virus season.
Express Tribune
4 hours ago
- Health
- Express Tribune
CDC updates COVID vaccine guidance, open option for healthy children
Moderna logo is seen displayed in this illustration taken, May 3, 2022. Photo: REUTERS Listen to article The US Centers for Disease Control and Prevention said COVID-19 vaccines remain an option for healthy children when parents and doctors agree that it is needed, stopping short of Health Secretary Robert F. Kennedy Jr.'s announcement that the agency would remove the shots from its immunisation schedule. 🇺🇲 #BREAKING: The CDC kept Covid shots on an updated vaccination schedule for children, days after Health Secretary Robert F. Kennedy Jr. said they would be taken off. Source: the New York Times — Ali (@iamsakibali1) May 30, 2025 In a schedule published late on Thursday, the CDC said any COVID vaccination in healthy children aged 6 months to 17 years should follow "shared clinical decision-making" between a child's parents and their healthcare provider. Kennedy, a long-time vaccine skeptic who oversees the CDC, the Food and Drug Administration and the National Institutes of Health, had said on Tuesday the recommendations would be dropped. "As of today, the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunisation schedule," Kennedy said in a video posted on the X platform. A spokesperson for the Department of Health and Human Services said there was no contradiction between Kennedy's statement and the CDC schedule, which no longer provides a broad recommendation for healthy children. Kennedy's announcement prompted criticism from medical experts who said the health secretary circumvented the government's decision-making process on vaccines and could prevent health insurance coverage for COVID shots to vulnerable Americans. The Infectious Diseases Society of America said on Tuesday that removing the recommendation "does the opposite of what Americans have been asking for when it comes to their health — it takes away choices and will negatively impact them." It added infants and children may "develop severe disease and may suffer from prolonged symptoms due to long COVID, which can negatively impact their development." Nearly 1,900 children up to 18 years of age died of COVID in the US, according to CDCupdated in 2023. The makers of COVID vaccines available in the US — Pfizer,Moderna and Novavax — did not immediately respond to requests for comment. Traditionally, the CDC's Advisory Committee for Immunisation Practices would meet and vote on changes to the immunization schedule or recommendations on who should get vaccines before the agency's director made a final call. The committee had not voted on the changes announced by Kennedy. Last week, the FDA said it plans to require new clinical trials for approval of annual COVID boosters for healthy Americans under 65, effectively timing them to older adults and those at risk of developing severe illness. Reporting by Susan Heavey in Washington, Puyaan Singh in Bengaluru and Michele Gershberg in New York; Editing by Alan Barona, Shounak Dasgupta and William Mallard
