Time.news – Pfizer’s Covid vaccine is safe for children between 5 and 11 years old. This was reported by the pharmaceutical company citing the results of clinical trials. The data has yet to be submitted for evaluation by the FDA and the process could be completed by the end of September. “In participants aged 5-11 years, the vaccine was shown to be safe, well tolerated and with a strong antibody response“Pfizer-BioNTech said, specifying that in that age group it was administered at a lower dosage (two doses of 10 micrograms 21 days apart, compared to 30 micrograms).
The presentation to EU and US authorities as soon as possible
The intention is to present the data to the regulatory authorities of the EU, the US and the rest of the world “as soon as possible”. Pfizer’s are the first available results: Moderna’s clinical trials on 6-11 year olds are still ongoing.
Immune response and safety ok
The companies reported that the vaccine generated an immune response in children aged 5 to 11 years in the phase II / III clinical trial, which confirmed what was previously observed also in boys aged between 16 and 25 years. The level of safety was also generally comparable to that of the older age group. “Since July, pediatric cases of Covid-19 have increased by approximately 240% in the United States, underscoring the need for vaccination for public health.” he has declared Pfizer CEO Albert Bourla in a press release. “These trial results provide a solid basis for applying for authorization of our vaccine for children between the ages of 5 and 11 and we plan to urgently present it to the FDA and other regulators. ”