Latest news with #USDepartmentofHealthandHumanServices
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First Post
2 days ago
- Business
- First Post
US vulnerable to bird flu but Trump administration cancels $766 mn Moderna vaccine deal
The US Department of Health and Human Services, under Robert F Kennedy Jr, said that after reviewing the Biden-era deal, it was found that the Moderna project did not meet the scientific standards or safety expectations required for continued federal investment read more A test tube labelled "Bird Flu", eggs and a piece of paper in the colours of the US national flag are seen in this picture illustration, January 14, 2023. File Image/Reuters US President Donald Trump's administration has cancelled a deal with Moderna vaccine worth $76 million at a time when cases have started flaring up in the country, affecting poultry. The former Biden administration had awarded Moderna a $590 million contract to advance the development of its bird flu vaccine and support the expansion of clinical studies for up to five additional subtypes of pandemic influenza. That deal now stands null and void, which effectively means that the drug maker does not have the authorisation to create vaccines and sell their shots. STORY CONTINUES BELOW THIS AD The US Department of Health and Human Services, under Robert F Kennedy Jr, said that after reviewing the Biden-era deal , it was found that the Moderna project did not meet the scientific standards or safety expectations required for continued federal investment. It is important to note that RFK Jr is a vaccine sceptic, particularly the mRNA technology that is employed in making Moderna vaccines. Moderna stocks tumble The company has been banking on revenue from newer mRNA shots, including its bird flu vaccine and experimental COVID-flu combination vaccine, to make up for waning post-pandemic demand for its COVID vaccine. After the announcement about its bird flu vaccine, shares of Moderna were flat in after-market trading. As it is, the company was not doing so good business-wise. In the first quarter, Moderna reported a loss of $2.52 per share on $86 million in product sales. While the loss was smaller than expected and an improvement over the $3.07 per-share loss from the same period last year, revenue fell short of expectations. Analysts polled by FactSet had projected sales of $107.3 million. Bird flu in US Bird flu has been spreading in the US for quite time, hitting the sale and consumption of poultry products and affecting businesses. As of May 6, the Centres for Disease Control and Prevention (CDC) recorded 70 cases of avian influenza and one death. In April 2024, the CDC confirmed the first human case of bird flu in a Texas dairy worker who had been exposed to cows suspected of being infected. This case is believed to mark the first known transmission of the H5N1 strain from mammals to humans. STORY CONTINUES BELOW THIS AD With inputs from agencies
AsiaOne
2 days ago
- Health
- AsiaOne
US cancels more than $700 million funding for Moderna bird flu vaccine, World News
The Trump administration has cancelled a contract awarded to Moderna for the late-stage development of its bird flu vaccine for humans, as well as the right to purchase shots, the drugmaker announced on Wednesday (May 28). Shares of Moderna were flat in after-market trading. Moderna in January was awarded US$590 million (S$760) by the Biden administration to advance the development of its bird flu vaccine, and support the expansion of clinical studies for up to five additional subtypes of pandemic influenza. This was in addition to US$176 million awarded by the US Department of Health and Human Services (HHS) last year to complete the late-stage development and testing of a pre-pandemic mRNA-based vaccine against the H5N1 avian influenza. HHS told Reuters earlier this year that it was reviewing agreements made by the Biden administration for vaccine production. "The cancellation means that the government is discarding what could be one of the most effective and rapid tools to combat an avian influenza outbreak," said Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, adding that it is the opposite approach Trump took with Operation Warp Speed to combat Covid-19. An HHS spokesperson said that after a comprehensive internal review, the agency had determined that the project did not meet the scientific standards or safety expectations required for continued federal investment. Bird flu has infected 70 people, most of them farm workers, over the past year as it has spread aggressively among cattle herds and poultry flocks. Health Secretary Robert F Kennedy Jr has questioned the use of vaccines and earlier this year drew censure from some in the US Congress after he suggested in a television interview that poultry farmers should let the bird flu spread unchecked through their flocks to study chickens who did not contract it. Moderna said it plans to explore alternatives for late-stage development and manufacturing of the vaccine. The company has been banking on revenue from newer mRNA shots, including its bird flu vaccine and experimental Covid-flu combination vaccine, to make up for waning post-pandemic demand for its Covid vaccine. Moderna also said on Wednesday that it had received positive interim data from a mid-stage trial set up to test the safety and immunogenicity of its bird flu vaccine targeting the H5 avian influenza virus subtype. [[nid:713266]]
Yahoo
2 days ago
- Business
- Yahoo
Premix opens new manufacturing facility in North Carolina
Premix Group, an electrically conductive plastics manufacturer, has inaugurated its new manufacturing facility in Apple Creek, North Carolina, US. The development of the facility was backed by a $79m investment from the US Department of Health and Human Services. It is expected to strengthen the domestic supply chain for crucial diagnostics and other high-impact applications. The facility will utilise US-sourced raw materials to produce advanced polyethylene- (PE) and polypropylene (PP)-based compounds and concentrates. These materials are seen as key for extrusion and injection moulding applications, enabling accurate liquid level detection and providing protection against uncontrolled electrostatic discharges. Such features are essential in diagnostics, chemicals, electronics, industrial packaging, and other high-performance applications. The Apple Creek plant will offer the US market locally manufactured products with reduced lead times, a smaller carbon footprint, and better supply chain security. Premix Group CEO Jaakko Aho said: "These materials enable high-precision liquid level sensing in diagnostic testing, and safer handling, transport, and storage by protecting against uncontrolled electrostatic discharges (ESD) - a critical requirement in electronics, industrial packaging, diagnostics, and other high-performance applications. "Establishing a manufacturing presence in the United States is about more than production - it's about building resilient supply chains and trusted partnerships." This strategic move expands Premix's global presence, building upon its foundation as a family-owned business established in Finland in 1983. Premix has production facilities in both Finland and the US, offering material solutions designed to improve safety and operational efficiency. "Premix opens new manufacturing facility in North Carolina" was originally created and published by Packaging Gateway, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
2 days ago
- Business
- Yahoo
Trump administration cancels multi-million dollar bird flu vaccine contract with Moderna
The Trump administration has cancelled a $766 million contract with Moderna for the development of its human bird flu vaccine, the company has announced. The pharmaceutical giant was awarded the multi-million dollar contract by the Biden administration last year, as the H5N1 virus began to ravage US dairy and poultry farms. It has since infected more than 70 people in America, killing one, and experts say it is only a matter of time before it starts to spread between humans – an event that could trigger a new pandemic. Just yesterday, an 11 year old boy died in Cambodia after becoming infected, the fifth H5N1 death in the region this year. A spokesperson for the US Department of Health and Human Services (HHS) said that after an internal review, the agency had decided to cancel the Moderna contact. Health secretary Robert F. Kennedy Jr, a long time vaccine sceptic, has repeatedly expressed concern over the safety of mRNA vaccines despite them having saved millions of lives during the Covid-19 pandemic. This week Mr Kennedy also announced that mRNA Covid vaccines would no longer be recommended for healthy children or healthy pregnant women. Currently, the US lacks sufficient bird flu vaccine stockpiles, with only 0.82 doses available per person, according to disease analytics firm Airfinity. The agreement with Moderna was intended to strengthen the country's pandemic preparedness by diversifying its emergency H5N1 vaccine stocks. It is thought mRNA vaccines can be developed and produced more rapidly than traditional flu vaccines which are grown in chicken eggs – a method that is both slow and difficult to scale. The cancellation of the contract came on the same day Moderna announced positive results for the jab from its first preliminarily clinical trials: testing of 300 people found the H5N1 vaccines to be 98 per cent efficacy, and 'generally well tolerated.' 'The cancellation [of the contract] means that the government is discarding what could be one of the most effective and rapid tools to combat an avian influenza outbreak,' Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security told Reuters. The European Union has secured 450 million doses of bird flu vaccines – enough for one dose per EU resident – from multiple manufacturers, including CSL Seqirus, GSK, and Pfizer. Moderna, founded just 11 years ago and based in Massachusetts, received over $30 billion in US government funding during the Covid-19 pandemic under the leadership Dr Anthony Fauci, which allowed it to quickly develop and deploy millions of doses of its vaccines. Protect yourself and your family by learning more about Global Health Security Broaden your horizons with award-winning British journalism. Try The Telegraph free for 1 month with unlimited access to our award-winning website, exclusive app, money-saving offers and more.
Yahoo
2 days ago
- General
- Yahoo
How changes to Covid-19 vaccine policy in the US may affect you
The US Department of Health and Human Services, under Secretary Robert F. Kennedy Jr., has recently made significant changes to how Covid-19 vaccines are approved and the groups they are recommended for. For the past few years, the federal government has broadly approved and recommended an updated Covid-19 shot for everyone ages 6 months and up each fall. But last week, leaders from the US Food and Drug Administration outlined a new framework for the approval process for Covid-19 vaccines that could limit shots to older Americans and people at higher risk of serious Covid-19 infection. On Tuesday, Kennedy announced that the vaccine will no longer be among the recommended vaccines for pregnant women and healthy children on the US Centers for Disease Control and Prevention's immunization schedule. These changes, made in unconventional ways, will probably affect access to and availability of Covid-19 vaccine shots for millions. Under the framework outlined by FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the new director of the FDA's Center for Biologics Evaluation and Research, updated Covid-19 vaccines will probably be approved for everyone 65 and older and for people 6 months and older who have at least one underlying condition that puts them at 'high risk for severe Covid-19 outcomes.' The CDC lists dozens of conditions that may contribute to higher Covid-19 risk, including asthma, cancer, diabetes, obesity and a history of smoking. These underlying conditions will make between 100 million and 200 million people in the US eligible for a Covid-19 vaccine under the new framework, the FDA leaders estimate. Pregnancy is included on the list of factors that the CDC says have shown 'a conclusive increase in risk' for at least one severe Covid-19 outcome. Kennedy did not offer a specific reason behind the decision to stop recommending the Covid-19 for pregnant people in Tuesday's announcement, but the move appears to directly contradict the new framework outlined a week earlier. For kids and adults younger than 65 who do not have an underlying condition, the FDA says it will require in-depth clinical trials before licensing new vaccines. An independent group of advisers to the CDC – the Advisory Committee on Immunization Practices, or ACIP – is expected meet at the end of June to vote on Covid-19 vaccine recommendations, and they had already been weighing options for more targeted risk-based recommendations than the general guidelines issued in previous years. Experts say next month's meeting could be a pivotal moment in the future of Covid-19 vaccine access, with much uncertainty around what will happen if the advisers recommend a different path forward than officials have outlined. Maybe, but it may be more difficult – and expensive. 'Theoretically, one could find someone who would be willing to provide them the vaccine – and they may have to pay out of pocket to get it – but there's a lot of things that have to align for that to happen,' said Dr. Michelle Fiscus, a pediatrician and chief medical officer of the Association of Immunization Managers. Health care providers, including pediatricians, may be able to provide the Covid-19 vaccine 'off-label' – but they'd need to have the vaccine in stock, which has become increasingly uncommon. The vast majority of Covid-19 vaccinations happen at pharmacies. Pharmacists generally don't have the tools to verify medical history and whether an individual has a condition that makes them high-risk, so many of them could take patients at their word. But the recent announcements from the federal government may have a chilling effect on what providers are willing to do, experts say. It's likely that people who are covered by public insurance such as Medicare and Medicaid and who meet the new FDA eligibility requirements will continue to have Covid-19 vaccines covered, experts say. There's more uncertainty around how private insurance companies will choose to adjust coverage. Some of the conditions that the CDC lists as high-risk for Covid-19 – such as 'physical inactivity' – are loosely defined and may be left up to individual plans to interpret. Under the Affordable Care Act, insurance companies are required to cover vaccines for adults if they've been recommended by ACIP. The committee also votes on whether vaccines should be added to the federal Vaccines for Children program, which provides vaccines to children who would not otherwise be able to afford them. However, there's a gray area around what will happen if ACIP recommendations differ from CDC recommendations, experts say. In a video posted on social media on Tuesday, Kennedy said that changes to the recommendations for children and pregnant people took effect that same day. As of Thursday morning, however, the CDC's recommended immunization schedule posted online had not changed. Last week's editorial from Makary and Prasad said that the new framework for vaccine approval would be adopted 'moving forward.' The FDA officials say the new policy balances the need to swiftly approve vaccines – to have them ready by the fall respiratory virus season for the most vulnerable adults and children – against the need for more evidence before offering them to others. Under this newly proposed framework, the FDA says, it will require additional evidence from vaccine manufacturers before approving updated Covid-19 shots for healthy kids and adults. The officials said those studies should last a minimum of six months, which would preclude any findings from influencing approvals in time for this fall. The CDC's independent vaccine advisers meet at the end of June and are expected to vote on this fall's Covid-19 vaccine recommendations. Their decisions have guided vaccine policy in the US for decades, but it's unclear how much influence it will have over the newly announced changes. HHS still hasn't signed off on two of the three recommendations that were made at the group's last meeting, in April. The Covid-19 vaccines that are currently available in the US have been approved by the FDA after rigorous analysis and are considered safe. In their editorial outlining the new framework for Covid-19 vaccine approval, the FDA's Makary and Prasad said that 'the benefit of repeat dosing … is uncertain,' but they did not present evidence that Covid-19 vaccines themselves are unsafe. The agency says it will approve vaccines for healthy kids and adults only after studies that prove that the shots can prevent symptomatic Covid-19 better than a placebo. However, the new plan doesn't take into account other effects of Covid-19 infections, such as long Covid. These changes to Covid-19 vaccine policy limit opportunities to protect people who are at high risk, including young children and pregnant people, experts say 'We have vaccines that we know were critical in saving lives during the pandemic and we continue to see the morbidity and mortality from Covid-19,' Fiscus said. 'It's very concerning that people who would choose to protect themselves or their children with a vaccine may have that choice taken away.' CNN's Brenda Goodman contributed to this report.
