An image image shows vials with COVID-19 vaccine stickers and syringes with the … more
In a significant policy shift last month, they were proposed by officials of the Food and Drug Administration Requiring new clinical trial survey Regarding the effectiveness of COVID-19 vaccines in healthy people under 65, including pregnant women, before issuing an up-to-date approval for a wider population. At the same time, in an update of the immunization timetable of Posted May 29Disease Control and Prevention Centers Include the choice of Covid-19 vaccines for healthy children and pregnant women. Based on the language used by CDC, it indicates that the body aims at a joint decision -making approach in which people consult their doctor before taking a shot.
We noticed a preview of the new FDA approach when the organization made a unusual decision To limit the approval of the nation’s unique Coronavirus vaccine, Novavax’s Novaxovid of Novavax, for use only in adults 65 years or older or to those 12 to 64 who have at least one health problem that puts them at increased risk by Covid-19.
To refer to a wider population, the FDA plans to demand vaccine manufacturers to carry out souvenir tests to show effectiveness in people under 65 or without certain risks. These tests could take a year to completeaccording to one Cross report. Therefore, it is not something that can be achieved before autumn, even if Novavax, Pfizer or Moderna wanted to follow this path.
Similar to the annual influenza downloads, which are adapted to new executives, the COVID-19 amplifiers informed immunity to evolving variants. Data from several years of commemorative campaigns have lower rates of hospitalization and mortality for reinforced individuals compared to non -vaccinated people or those who have not received amplifiers. This is especially true for vulnerable subpopulations, age -strained and underlying health conditions.
Covid-19 vaccines, both mRNA and non-mRNA, are recommended for those who are over 65 or having a medical condition that may increase the risk of serious illness or death. Underlying conditions include, inter alia, obesity, “physical inactivity”, diabetes, clinical depression and immunosuppressive. It is estimated that between 100 and 200 million Americans will still be eligible for vaccination due to the existence of such health issues.
However, this raises questions for people who have no underlying health conditions and are under 65, but would like to take a Covid-19 shot this fall. The FDA and CDC appear to be thinner in terms of their current tips for healthy people under 65. Is it possible for these people to get a jab at the pharmacy without questions? Or should they go to their doctor and give them a de facto license to get the plan? Maybe just as important, will their insurer pay for it?
As New York Times explainsInsurance companies can serve as “gates demanding medical documentation of an underlying condition before they agree to cover costs”. Cost out of pocket for patients could be so $ 140.
Top officials of FDA Prasad and Makary advocate An “evidence-based” approach to the vaccination of COVID-19. They also write about the alignment of politics with Europe. Indeed, in most cases, European public health authorities have adopted an targeted approach aimed at ensuring the elderly and underlying health conditions. This means that promotion campaigns in European countries are targeting only subpopulations for which the vaccine is recommended by the corresponding public health authority. This is in contrast to the universal recommendations previously issued by the CDC that did not differentiate the age or risk factors. However, European organizations responsible for the approval of the vaccine, EMA and MHRA do not suggest changes to the authorization of marketing for amplifiers, such as a decrease in age-based indication for any of the approved COVID-19 vaccines. And in almost all cases, COVID-19 vaccines can be free of charge throughout Europe, regardless of health or age.
