Pfizer executives: 5 to 11-year-old children’s vaccine is expected to obtain EUA in autumn and winter | Anue Juheng-US stocks

Scott Gottlieb, a member of Pfizer’s board of directors and former director of the US Food and Drug Administration (FDA), told CNBC on Monday (30th) that the Pfizer/BioNTech vaccine for children aged 5 to 11 will be approved by the FDA at the end of this fall or early winter. Emergency Use Authorization (EUA).

Gottlieb said that Pfizer’s vaccine data for this age group of children should be released in September and sent to the FDA that month, but he said that it may not apply for EUA until October.

Gottlieb said: “If the FDA adheres to the normal review process, in terms of its review of EUA applications, it will take about 4 to 6 weeks to review, so the time will probably fall within the interval between the end of autumn and the beginning of winter.”

Gottlieb’s forecast is consistent with the forecast by Anthony Fauci, the Chief Medical Adviser of the White House.

Pfizer (PFE-US)/BioNTech(BNTX-US) The company’s vaccine is currently the only vaccine fully authorized by the FDA. However, this authorization is only limited to 16 years of age and older. Although children between 12 and 15 years old can still administer it, it is limited to emergencies.

In the United States, the ability to vaccinate children is an important step in the fight against the epidemic, especially during the return-to-school season in the fall. Last week, the number of pediatric hospitalizations due to the new coronavirus infection reached a new high since health officials began a record a year ago. Although the risk of the new coronavirus to children is lower than those of people over 65 years old, some studies have shown that children infected with the virus can still be infected with the virus. Infect other people.

Delta spread will become the key to accelerated FDA review

Gautrib said that if all goes well, the review time is expected to be shortened, but variables are not ruled out. He said that if the FDA decides to conduct a 3- to 6-month follow-up survey of children in clinical trials, the authorization may be extended.

On the other hand, Gautrib said that the highly contagious Delta transvirus may affect the vaccine review process for young children. If the mutant virus continues to spread to the northeastern United States, the FDA will be under greater pressure to control the epidemic, so it may The vaccine will be approved as soon as possible.

In addition, Gottlieb said that Pfizer’s trial data for children under 5 years old will not be sent until November because the data is not sufficient. He added that the dose of vaccine used in this age group is lower than that for children 5 to 11 years old. Low.

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