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With the vaccine from the US company Johnson & Johnson, a third corona vaccine may be used in the US in the future. The United States Food and Drug Administration (FDA) granted emergency approval for the drug on Saturday (local time). It unfolds its full effect after the administration of one dose and, unlike the other vaccines used, it does not have to be injected twice.
Following the FDA, an advisory panel from the CDC health authority also came out in favor of widespread use of the Johnson & Johnson vaccine on Sunday. The CDC official was expected to follow the experts’ recommendations and that the first doses would be administered overnight or on Monday.
US President Joe Biden spoke of “exciting news for all Americans and an encouraging development in our efforts to end the crisis.” There are comparatively low barriers to emergency FDA approval. In short, it must be ensured that a drug or vaccine does more than harm. Regular approval is a much longer process.
Available data on the Johnson & Johnson vaccine showed that “the known and potential benefits of the vaccine outweigh its known and potential risks,” the FDA advisory said. The basis for this is tests with tens of thousands of subjects in various countries. The emergency approval applies to the use of the active ingredient in people over 18 years of age. Data on the duration of vaccination protection is not yet available, the FDA said. There is also no reliable information on whether vaccinated people transmit the SARS-CoV-2 virus.
So far, only two corona vaccines have been approved in the US: The vaccine from Mainz-based pharmaceutical company BioNTech and its US partner Pfizer and the competing product of American pharmaceutical company Moderna. BioNTech / Pfizer, Moderna and AstraZeneca vaccines are on the EU market. The EU Commission has ordered vaccination doses for 200 million people from Johnson & Johnson. Plus, you have the option of quantities sufficient for another 200 million people.
In early February, Johnson & Johnson applied to the FDA for emergency approval for the corona vaccine developed by its pharmaceuticals division. The application to the EU Medicines Agency EMA followed in mid-February. The EMA said it would test the vaccine from Johnson & Johnson’s subsidiary, Janssen-Cilag International NV, in an expedited process. The responsible commission could give its assessment in mid-March.
At the end of January, Johnson & Johnson announced an interim result of its phase III study of about 44,000 test subjects, according to which the vaccine offers 66 percent protection against moderate or severe COVID-19 disease courses. four weeks after administration. The effectiveness against serious diseases was 85 percent. The percentages mean that consequently there were fewer cases in the vaccinated test group than in the placebo test group. According to the results of the study, the effectiveness of some competitive products is higher, but the values of the Johnson & Johnson preparation are still considered good.
In the United States, where about 330 million people live, more than 28 million people have been infected with the SARS-CoV-2 pathogen and more than 510,000 have died. In absolute terms, that is more than in any other country in the world. More than 70 million doses of vaccines have already been injected.
US President Biden saw the approval of a third vaccine as an important step in dealing with the pandemic. There is “light at the end of the tunnel”, but there is no reason to give the go-ahead, he warned on Saturday night (local time). It is essential to vaccinate as many people as possible as quickly as possible and to continue to comply with the rules of distance and hygiene.
Lead immunologist Anthony Fauci told CNN on Sunday that with the approval, the United States now had “another very good vaccine in the mix.” People should get vaccinated as soon as possible, regardless of the approved vaccine. Biden’s adviser warned against reducing protective measures too soon. There is a risk that the number of cases will increase again.
