Pfizer applies for a license to use vaccines for children aged 5-11 in Canada

Pharmaceutical companies Pfizer (USA) and BioNTech (Germany) on October 18 submitted a dossier requesting the Ministry of Health Canada to approve the use of a COVID-19 vaccine, jointly developed by these two companies, to be administered to children within a certain age range. ages 5-11.

Pfizer-BioNTech's COVID-19 vaccine. Photo: AFP
Pfizer-BioNTech's COVID-19 vaccine. Photo: AFP

A statement by Pfizer/BioNTech and the Government of Canada said that this is the first time Health Canada has received an application for approval to use a COVID-19 vaccine for children aged 5-11. The application was submitted based on vaccine trial data on 2,268 children in this age group, with dosages reduced to 10 micrograms of vaccine per shot, just one-third of the standard dose.

Health Canada said it will only approve the vaccine for children aged 5-11 years if independent and thorough scientific evaluation of all submitted data shows that the benefits of the vaccine outweigh the risks to the group. this age. Canada currently allows the use of Pfizer/BioNTech vaccines for people 12 years of age and older.

Earlier this month, Pfizer/BioNTech also asked for approval to vaccinate children aged 5-11 in the US.

On the same day, October 18, the Commission on Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) approved two new production facilities for Pfizer/BioNTech's COVID-19 vaccine. . In addition, the agency also approved a new formula for the vaccine.

In the announcement, CHMP said that the new production sites include a facility in Monza (Italy) operated by the pharmaceutical company Pacheon Italia S.p.A. operated and a facility in Anagni (also in Italy) operated by Catalent Anagni S.R.L. Both of these facilities will produce finished vaccines, which are expected to provide an additional 85 million doses of vaccine to EU countries this year. The decision does not need to be approved by the European Commission and the facilities can be put into operation immediately.

In addition, CHMP has approved a new, more convenient formulation for Pfizer/BioNTech's vaccines. This formulation requires no dilution prior to use, will be packaged in a box of 10 vaccine vials (equivalent to 60 doses) and can be stored at 2-8 degrees Celsius for up to 10 weeks. The concentrated formulation in use currently requires dilution prior to injection, is packaged in a box of 195 vials (equivalent to 1,170 doses) and can be stored at 2-8 degrees Celsius for up to one month. . These differences will help improve storage, transportation and logistics to ensure vaccine distribution and administration. The new formula will be applied in phases, starting in early 2022.

On the same day, the Vietnam News Agency correspondent in Tel Aviv quoted Sputnik radio as saying that Israel is working on a pilot mechanism to allow entry for tourists who have been vaccinated with the Sputnik V vaccine against COVID-19. This mechanism will be presented to the Prime Minister of Israel for consideration on October 20.

From November 1, Israel will accept all foreign visitors who have been vaccinated with vaccines recognized by the World Health Organization (WHO), the source said. Currently, the Russian vaccine Sputnik V is not on the list, but thanks to the efforts of the Israeli Ministry of Tourism and after recent meetings, there will be a testing mechanism. This mechanism will be presented to the Prime Minister on October 20.

According to the same source, visitors entering Israel will be required to take PCR tests and serological tests, which will usually take less than 48 hours.

Earlier, local media reported that Israel's Ministry of Tourism was considering a proposal to reopen the border soon to welcome foreign tourists who have been vaccinated against COVID-19. Tourism Minister Konstantin Razvozov said the ministry is also working on a mechanism to allow Russian tourists to enter Israel.

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