At the Wired Health Summit on Tuesday, Modern CEO Stephne Bancel said the recent changes COVID-19 Vaccine policy made by health and human service secretary Robert F. Kennedy, Jr. is a ‘step back’.
Moderna is one of the manufacturers of MRNA-based COVID-19Gaccins and last month the company received approval from the Food and Drug Administration for a Updated version of the recording. But as part of that approval, the FDA imposed new restrictions on whom the vaccine can receive. Earlier Covid -vaccines were recommended for everyone aged 6 months or older. Now the FDA says that they should only be given to people with a high risk of serious diseases, either because they are 65 and older or have other health problems.
“I think it complicates things for people,” said Bancel. “You may have someone in your household – a parent, a husband, a child – who runs a high risk” that you want to protect, he said. In the past, healthy people could just go to a pharmacy to receive a Covid shot. Now different states need a recipe to get a Covid recording due to the changes of the FDA.
Kennedy is on one Crusade against vaccines Because he stepped into the role of HHS secretary in February; Earlier this week, the Senate Financing Committee grew him so far about his actions in office.
In May, Kennedy ended a $ 590 million contract with Moderna for the development of a mrna-based bird flu Vaccine candidate. The contract was awarded during the last days of the Biden administration in January, just before President Donald Trump’s second term started. Bird flu is widespread in wild birds and has caused outbreaks in poultry and American dairy cows since March 2024. It has sporadic cases in humans, most of them agricultural workers, but forms a pandemic potential when it develops the ability to spread from person to person.
That same month, Kennedy announced that HHS would no longer recommend MRNA COVID-19 vaccines for healthy children and pregnant women. In June, the FDA said that the new labels on MRNA vaccines would require safety information about the risks of myocarditis and pericarditis, rare side effects that are usually observed in young men after administering the recordings.
In August, as part of a “coordinated wind” from MRNA vaccine research, HHS has canceled 22 related contracts and investments worth nearly $ 500 million. Kennedy wrongly said in a statement that these vaccines “do not effectively protect them against upper airways such as Covid and Flu.” Instead, HHS changes financing to an older vaccine platform that is known as “whole virus” vaccines.
Despite the return of the administration to MRNA vaccins, Bancel said that he is ‘encouraged by the dialogue’ that the company had with the FDA. In addition to getting updated Covid shots, although with limitations, Modernna also received extensive approval for his respiratory syncytial virus, or RSV, vaccine with adults aged 18 to 59 who run an increased risk of illness. The vaccine was initially approved in May 2024 for adults aged 60 and older.
“I think many people in January, including my own team, were that we might not get those approvals,” said Bancel.
The performance of the administration against MRNA research so far has not expanded to the cancer space and Moderna develops various MRNA therapies against cancer, including personalized cancer vaccines. The company has 45 cancer-related programs in the pipeline and has said that it expects 10 FDA approvals in the next three years. “We use exactly the same technology to go from infectious diseases to cancer,” said Bancel.
He was also about accusations that the Covid vaccines were not properly tested. “I don’t think more vaccine has been studied for efficacy and safety in the history of vaccines,” he said. “With regard to the efficacy and safety of vaccine, studies have been done with literally millions of people in the real world.”
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