Bennett asks Pfizer CEO to speed up vaccine approval for kids under 12
PM’s office says Albert Bourla committed to working ‘to the best of his ability’ to move the process along and expand eligibility
Prime Minister Naftali Bennett spoke on Thursday with Pfizer CEO Albert Bourla and urged him to speed up regulatory approval of the pharmaceutical giant’s COVID-19 vaccine for those under the age of 12.
Bourla told Bennett he views the issue with great importance and will work to the best of his ability to speed up the process, according to the Prime Minister’s Office.
The pair also discussed Israel’s distribution of third dose booster shots to its over-60 population, the PMO added.
Pfizer has previously said it expects to apply in September for children ages 5 through 11. Results for two younger age groups that began testing a little later should be available by October or November, according to the company.
Fellow United States vaccine maker Moderna said last month that it expects to have enough data to apply for US Food and Drug Administration authorization in younger kids by late this year or early 2022.
Also in July, an unnamed FDA official told NBC News that emergency authorization for COVID-19 vaccines to be administered to children under the age of 12 may come as early as this coming winter.
Currently, the Pfizer-BioNTech vaccine is being distributed under an emergency use authorization, which can be revoked when the COVID-19 crisis ends. The company announced in May that it was seeking full FDA approval, which would allow the vaccine to remain on the market and be sold to customers directly.
The emergency use authorization only applies to those over 12 for now, as the company is seeking approval from the FDA to administer its COVID-19 vaccine to children aged 2-11.
In March, both Pfizer and competitor Moderna launched trials of their vaccines for children under 12. The results, which will be reviewed by the FDA, are expected in the fall, according to NBC.
According to the FDA official, the agency is seeking at least four to six months of safety follow-up data for children under 12. For adults, only two months were required to receive emergency approval.
For full FDA approval, at least six months of follow-up data is required, NBC said.
Israeli health officials have recommended only vaccinating children under 12 who suffer from preexisting conditions that may put them at risk if they contract COVID-19.
Earlier on Thursday, Bennett instructed health maintenance organizations to prepare to expand the campaign to administer a third dose of the COVID-19 vaccine to younger Israelis starting next week.
Hebrew-language media reports said the booster shot drive will be expanded to those 50 and up next week, and possibly to those 40 and up soon after.
Out of Israel’s population of some 9.3 million, over 5.8 million have received at least one vaccine dose, and nearly 5.4 million have gotten two.
At the end of last month, Israel rolled out a third vaccine shot to citizens aged 60 and up. Over 715,000 have been administered a third booster shot since.
Israel hopes the booster shot will begin to show results soon and slow the growth in the number of serious cases amid the rapid spread of the super-contagious Delta variant of the virus.
