With the vaccine from the US company Johnson & Johnson, a third corona vaccine can be used in the USA in the future. The US Food and Drug Administration (FDA) issued emergency approval for the drug on Saturday. It unfolds its full effect after administration of one dose and – unlike the other vaccines used – does not have to be injected twice. US President Joe Biden spoke of “exciting news for all Americans and encouraging development in our endeavors to end the crisis”.
There are comparatively low hurdles for emergency approval by the FDA. Put simply, it must be ensured that a drug or vaccine demonstrably helps more than it does harm. Regular approval is a much longer process.
The available data on the Johnson & Johnson vaccine indicated that “the known and potential benefits of the vaccine outweigh its known and potential risks,” the FDA notice said. The basis for this are tests with tens of thousands of test subjects in several countries. The emergency approval applies to the use of the active ingredient in people aged 18 and over. Data on the duration of vaccination protection are not yet available, said the FDA. There is also no reliable information on whether vaccinated people transmit the SARS-CoV-2 virus.
So far, only the vaccines from Biontech / Pfizer and Moderna have been approved in the USA
So far, only two corona vaccines have been approved in the USA: The vaccine from the Mainz-based pharmaceutical company Biontech and its US partner Pfizer, as well as the competing product from the US pharmaceutical company Moderna. In the EU, vaccines from Biontech / Pfizer, Moderna and Astrazeneca are on the market. The EU Commission has ordered vaccination doses for 200 million people from Johnson & Johnson. It also has the option of sufficient amounts 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 that the vaccine from Johnson & Johnson subsidiary Janssen-Cilag International NV will be tested in an accelerated process. The committee responsible could give its assessment in mid-March.
At the end of January, Johnson & Johnson announced an interim result of its Phase III study with around 44,000 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 illnesses was given with 85 percent. The percentages mean that there were correspondingly fewer cases in the vaccinated test group than in the placebo test group. According to study results, the effectiveness of some competing products is higher, but the values of the preparation from Johnson & Johnson are still considered good.
US President Biden: “Light at the end of the tunnel”
In the USA, where around 330 million people live, over 28 million people have been infected with the Sars-CoV-2 pathogen and more than 510,000 people have died. In absolute terms, that is more than in any other country in the world. More than 70 million vaccine doses have already been injected.
US President Biden saw the approval of a third vaccine as an important step in coping with the pandemic. There is “light at the end of the tunnel”, but no reason to give the all-clear, he warned on Saturday evening. It is crucial to vaccinate as many people as possible as quickly as possible and to continue to adhere to distance and hygiene rules.