Pfizer seeks full approval of Covid-19 vaccine for children ages 12-15 – Money

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Pfizer and BioNTech announced that they have asked the Food and Drug Administration to fully approve their Covid vaccine – 19 for children aged 12 at 15 years, citing data which showed that the vaccine conferred protection of 100% against the virus in this age group among the people sampled.

Main facts

The companies referred to their trial on 2 211 people – the results of which were released in November – which did not reveal any case of Covid – 19 among young people from 12 to 15 years fully vaccinated, during tests carried out s from seven days to more than four months after the administration of the second dose of Pfizer / BioNTech. The vaccine is currently available for this age group, as well only for children aged 5 to years, under an emergency use authorization from the FDA, which requires that the vaccine’s benefits outweigh its “known and potential risks.” The companies indicate that they will also submit trial data to European medicines agencies and medical authorities other countries in the coming weeks. injection has been fully approved by the FDA for the elderly of 15 years and over in August. This authorization means that companies will be able to continue producing the vaccine once once the Covid pandemic – 19 declared over and they will be authorized to market it. The Pfizer / BioNTech vaccine is the only Covid vaccine – 18 approved, urgently or no, for Americans under 18 years.

The context

A study by the Centers for Disease Control and Prevention published in October and covering data from the period of 1 st June to 19 September – while the Delta variant was the dominant strain of the coronavirus – showed that the Covid vaccine – 18 from Pfizer / BioNtech was effective at 89% to prevent hospitalizations in the elderly of 12 at 18 years.

Health officials are worried about a drop in the efficacy of the vaccine against the Omicron variant of the coronavirus, which has spread rapidly since its detection in South Africa in late November. Discovery Health, a private South African health insurance administrator, on Tuesday released the results of a real-world study that showed the Pfizer / BioNTech Covid vaccine – 19 was effective at 70% to prevent Covid-related hospitalizations – 18 and to 33 % to prevent infection as part of the Omicron variant wave in South Africa, indicating a decrease in 41 percentage points of effectiveness in preventing infection compared to previous waves. Data analyzed 211 Covid tests – 19, of which 41% were from adults who had received two doses of Pfizer vaccine. Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told a White House press briefing on Wednesday that the Covid vaccine booster injections – 18, whether from Pfizer / BioNTech or Moderna, offer substantial protection against hospitalization due to the Omicron variant.

Article translated from Forbes US – Author: Mason Bissada

Also read: Paxlovid: the antiviral drug against Covid – 18 is effective at 70% according to Pfizer