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The FDA Just Approved A New Covid Vaccine
Moderna's original Covid vaccine Marcos del Mazo/Getty
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The Food and Drug Administration (FDA) just green-lit a new Covid vaccine from Moderna, the company said in a press release Saturday. Now the vaccine will bump up against an administration that is loath to recommend it.
The vaccine, called mNEXSPIKE, was approved for adults 65 and older, and people between 12 and 64 years old with "one or more underlying risk factor" defined by the Centers for Disease Control and Prevention (CDC), including conditions like cancer, asthma, and HIV. In a clinical trial of more than 11,000 participants, the vaccine showed higher efficacy than Moderna's earlier vaccine.
According to Moderna CEO Stéphane Bancel, the shot offers an "important new tool to help protect people at high risk of severe disease." Covid, as Bancel noted in the press release, "remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone."
Moderna's announcement comes just days after Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. Announced in a video posted to X that the CDC would drop Covid vaccine recommendations for healthy children and pregnant women, a decision made outside the agency's formal expert review process. Previously, everyone 6 months and older was advised to get vaccinated.
"I couldn't be more pleased to announce that as of today, the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule," Kennedy said on X. "We're now one step closer to realizing President Trump's promise to make America healthy again."
Many experts in the medical community expressed concern about the guidance and how it was delivered. "We were not consulted about this," Dr. Sean O'Leary, chair of the American Academy of Pediatrics committee on infectious diseases, told ABC News. "My biggest concern is about the process. This really ignores a long-established, evidence-based process that has been used to make vaccine recommendations in the US."
While children are at less risk from Covid generally, many, especially young children, can develop severe illness. Pregnant people, too, are at heightened risk of illness and complications.
On Thursday, the CDC updated its guidance, with a clarification to Kennedy's plans: Healthy children can still get the vaccine, the CDC said, through "shared clinical decision-making" between their parent and doctor. In other words, rather than advising against the vaccine, the CDC recommended parents speak to their doctors about it. (The American Academy of Family Physicians and the American Academy of Pediatrics recommend children get the vaccine.) The agency's Covid vaccine guidance for pregnant adults reads, "No Guidance/Not Applicable."
All this is likely to thwart the impact of Moderna's shot. Experts worry the changes in recommendations will mean insurers will be less willing to cover Covid vaccines or doctors less likely to stock them, making them harder to access. As former Moderna executive and George Washington University health care law lecturer Richard Hughes told NPR earlier this week, "Expect variability in coverage, prior authorization and out-of-pocket [costs], all of which will discourage uptake."
Experimental Flu Vaccines To Be Made At Duke
Published September 5, 2024
The Duke Human Vaccine Institute has been awarded a $7 million contract from the National Institute of Allergy and Infectious Diseases (NIAID), to manufacture H5N1 avian flu vaccines for use in clinical trials.
This particular strain of influenza has recently been identified in dairy cattle and is now present in herds in 18 states. The Centers for Disease Control and Prevention (CDC) has reported 13 cases of avian flu in humans since April 2024.
"We will be developing two investigational mRNA vaccines targeting avian influenza, one is a more traditional vaccine, and one is a computationally-designed vaccine," said Thomas Denny, chief operating officer of the Duke Human Vaccine Institute (DHVI). The mRNA approach is the same kind of vaccine used against COVID.
The award from NIAID, which is a part of the National Institutes of Health, is part of a contract called the Collaborative Influenza Vaccine Innovation Centers (CIVICs), which NIAID set up to develop new influenza vaccines that induce long-lasting immunity and protect against more variants of the virus. DHVI is unusual in having a Good Manufacturing Practices (cGMP) program that enables it to rapidly produce experimental new vaccines in sufficient quality and quantity to use in clinical trials.
The first investigational vaccine DHVI is being asked to make is more of a traditional design.
"The second mRNA vaccine that we're making is what we call more of a central immunogen designed vaccine. Think of this as more of a central immunogen vaccine designed around the evolution of the virus," Denny said. "With this type of vaccine design the hope is that it will elicit a broad spectrum of antibodies against avian flu and reduce the need to adjust the vaccine periodically should we see new strains of avian flu develop.
"This is in contrast to what currently occurs for COVID vaccines as new strains develop and we need to frequently update the vaccine."
If the virus that's circulating now and has infected those 13 people changes a year from now, this vaccine could still provide coverage. The hope is also that a broadly effective vaccine would reduce or eliminate the need of boosting year after year as the type of flu changes.
DHVI employs a team science approach and collaborated with the research team at Erasmus University Medical Center in the Netherlands who discovered the influenza immunogen.
"We expect to complete manufacturing this fall, with the goal of having vaccines ready for Phase 1 clinical trials to begin in early 2025," Denny said.
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