“We officially presented our request to the FDA for the authorization for the emergency use (Eua) “in the USA” of our anti-Covid vaccine in children from 5 to less than 12 years “. The Pfizer company communicated it via Twitter, after having started the process in recent days together with BioNTech by presenting to the US agency data from the phase 2/3 study on the anti-Covid vaccine in children aged 5 to 11 years. Now the request for ok for the emergency use of the shield product in the 5-11 range. It is highly probable that the next step will be to submit the same request to EMA, the European Medicines Agency.
The two manufacturers have defined their vaccine as safe and well tolerated by children but before predicting the start of the vaccination campaign even for 5-11 year olds it will obviously be necessary to wait for the decision of the authorities of the regulatory agencies.
If and when the green light of the Food and Drug Administration, will be a decisive turning point in the American vaccination campaign first, then worldwide. Until now, the “vaccinability” bar was fixed at 12 years, except in some countries such as Cuba, which has been vaccinating for weeks from two years upwards, using Soberana 2, a vaccine produced on the Caribbean island albeit not yet recognized by the World Health Organization.
As far as it is concerned Pfizer and BioNTech, producers of the Comirnaty vaccine, the most used in Italy, on 20 September they presented the results of their experimentation on the pediatric age group 5-11 years. The results show a favorable safety profile e solid neutralizing antibody responses. The two companies said their vaccine was “safe, well tolerated” and produced a “robust” immune response in children between the ages of five and 11.
The experimentation is done using a two-dose regimen of 10 µg (micrograms) given 21 days apart, less than the 30 µg dose used for people aged 12 years and over. Antibody responses in participants who were given doses of 10 µg were comparable to those recorded in a previous Pfizer-BioNTech study in people aged 16 to 25 years immunized with doses of 30 µg. The 10 µg dose was carefully selected as preferred dose for safety, tolerability and immunogenicity in children aged 5 to 11 years.
Meanwhile it was the validity of the Pfizer vaccine in a frozen vial is extended by three months, which then passes from 6 to 9 months. The storage conditions do not change and foresee a temperature between -90 ° C and -60 ° C. The Italian Medicines Agency (Aifa) specifies this on its website. During the shelf life of 9 months, unopened vials can be stored and transported at -25 ° C to -15 ° C for a single period of up to 2 weeks, and can be brought back to a temperature between -90 ° C and -60 ° C. This three-month extension also applies retroactively, AIFA specifies, to vials produced before the approval date of 10 September. All vials with an expiration date after March 2022 will already be updated with the new shelf life of 9 months.
Meanwhile, according to a study published by the University of Nagasaki in southern Japan, receiving both doses of Pfizer or Moderna vaccine against the coronavirus would ensure an efficacy against the development of the disease of 86.6%. The team of researchers, who conducted the study between July and August looking at data from ten hospital facilities spread across eight prefectures across Japan, including Tokyo, Nara, and Nagasaki itself, looked at a sample of 890 individuals aged between 16 and 64 years old suspected of being infected with Covid-19. The results of the study go against those published by the National Institute of Infectious Diseases (NIID), according to which the effectiveness of vaccines would be of nearly ten points higher, or 95%. “Our studies suggest that vaccine efficacy may have weakened by the time the delta variant became widespread. Despite this, it is fully confirmed that vaccine efficacy still remains very high even in Japan,” commented Haruka Maeda, researcher of the Nagasaki working group.
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