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(CNN) – Pfizer CEO Albert Bourla said the company has a goal of making COVID-19 vaccines for children under 5 years old available in June, if the US Food and Drug Administration decides to do so. The US (FDA) approves them.
“I hope … Our goal is to have them by June,” Bourla said on the “In The Bubble with Andy Slavitt” podcast, which aired Monday.
Bourla noted that the FDA has been extremely cooperative and very flexible in addressing the public health need to make the vaccine available to younger children.
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Late last year, Pfizer and BioNTech’s vaccine for children under 5 was tested with two doses, but the results were not what scientists expected. In that sense, the companies said they would test a third dose.
However, at the request of the FDA, the companies submitted an emergency use authorization application for two doses of the vaccine and said they would continue to test a third dose while the first two went through the regulatory process. In mid-February, the agency said it needed to see data from an ongoing trial of a third dose of the vaccine in these younger children, in order to move forward with emergency use authorization.
“What happened was omicron. So, when we started to compare not only with delta, which was the previous one, but with omicron, we realized the same as in adults”, said Bourla. “In adults, two doses provide very little protection against delta. The third dose provides very strong protection. So we realized that this is the case for pediatric patients as well, so we expanded the trials to get to the third dose.”
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“Very soon we will provide data on the third dose, which we think will give much better results,” Bourla told Slavitt.
Bourla also discussed the safety of the vaccine in this age group. And she stated that “safety is of the utmost importance”, which is why they opted for a low dose of the vaccine.
“I know that, so far, security seems very, very good,” he said. “What I hope is that we will not have any security problems. We are waiting to see the effectiveness and my expectation is that it will be very good”.
The-CNN-Wire
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