US agency: FDA advises on BioNTech vaccine for children

Status: 10/26/2021 5:50 a.m.

The US FDA is advising on approval of the vaccine from BioNTech and Pfizer for children. The government has already prepared a roll-out.

By Torsten Teichmann, ARD Studio Washington

This time the US government wants to be properly prepared: Vaccines are available for all children in the US between the ages of 5 and 11. Lower-dose vaccines of the BioNTech / Pfizer type, said White House advisor Jeff Zients.

We have cans for 28 million children. There are many families waiting to have their children vaccinated. And there are families who have questions about it.

In a survey by a major US health insurance company, 32 percent of the parents surveyed stated that they would like to wait and see if the vaccine should be approved by an emergency prescription. 24 percent completely refused to vaccinate their children. Another third of the respondents are waiting for the vaccine.

One third of the normal dosage

To do this, the US drug agency FDA must first decide whether the dosage can be approved for use in the United States for children under 12 years of age. That is why the authority’s expert council meets. The scientists evaluate the results of clinical trials. In the final test series, BioNTech / Pfizer administered 1,150 children between the ages of 5 and 11 a newly dosed vaccine containing a third of the active ingredient.

Other children in the test series received a saline solution as a control group. The pharmaceutical manufacturer speaks of a success and promises a high level of protection against Covid disease for children as well. The FDA must now clarify whether the manufacturer’s data are sufficient. And: whether the benefit of a vaccination outweighs the risk of side effects. The outcome of the meeting is open.

25,000 paediatricians should help

The US government says it does not want to anticipate the decision. But at the same time everything is prepared for an emergency approval, says CDC director Rochelle Walensky.

Once we have FDA approval and recommendations from the CDC, we will try to increase the number of vaccinations in children.

The US government has committed more than 25,000 paediatricians to help, as well as pharmacies and hospitals, said Jeff Zients.

To make vaccination even easier for children, we are working with school districts so that they can be vaccinated directly in schools. We bring pharmacies and other providers together with school districts.

The pharmaceutical manufacturer Moderna also announced yesterday that the company’s corona vaccine had been successfully tested in children. But there is still no date for an emergency approval. In contrast to the EU, the vaccination of Moderna is currently only approved for people aged 18 and over in the USA.

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