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US third dose of vaccine hits the road on September 20, the Biden government rushes to announce approval before FDA approval | Anue Juheng-US stocks

US health officials officially announced on Wednesday (18th) that with new data showing that vaccine protection is gradually weakening, the United States will begin to administer a third dose of vaccine to the public in late September. The first announcement of the plan has aroused criticism from experts and scholars.

Officials from the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and White House chief epidemic prevention expert Anthony Fauci said in a statement on Wednesday that there is now clear evidence that over time, vaccines The immunity produced by vaccination will begin to decline. As the Delta variant virus rages, the vaccine’s protection against mild and moderate symptoms is showing signs of decline.

The CDC study showed that the immunity of Pfizer and Moderna vaccines weakened within a few months after complete vaccination. A study conducted in New York from May 3 to July 25 showed that the vaccine’s effectiveness in preventing infection dropped from about 92% to 80%. Another study by Mayo Clinic showed that Pfizer’s vaccine protection dropped from about 76% to 42%, and Moderna’s vaccine protection dropped from 86% to 76%.

Therefore, the U.S. health agency will provide a third dose to Americans who have been fully vaccinated with Pfizer and Moderna vaccine for 8 months from September 20. As for the Johnson vaccine vaccinators, additional doses may be required, but they are currently waiting for the next few days. More data on supplemental doses will be released every week before formal recommendations will be made.

The plan must be formally recommended by the CDC Vaccine Advisory Committee and formally approved by the FDA.

U.S. President Biden said in a speech at the White House on Wednesday that the supplementary dose will boost people’s immunization, and he disagreed with opponents’ call for the vaccine to be allocated to other countries first. He said that the United States can provide a booster while still providing global support. vaccine.

Israeli study: additional vaccines to enhance protection

Currently, studies have shown that boosters can further improve the protection. The preliminary research results released by Maccabi, the top four health care providers in Israel, on Wednesday showed that after the third dose of Pfizer/BioNTech vaccine for elderly people over 60, the protection increased to 86. %.

Maccabi chief statistician Anat Ekka Zohar said that the three-dose vaccine has a strong protective effect on infections and severe illnesses, and this is a solution to curb the current outbreak of infection.

However, the plan still faces other waves of opposition. The University of Pennsylvania bioethicist Holly Fernandez Lynch said that before the FDA changes the emergency authorization (EUA) or grants full approval, the US government endorses the additional vaccine dose and is actually supporting it. What is currently not allowed by law, any use of vaccines beyond EUA regulations will be unauthorized.

Dorit Reiss, professor of vaccine policy at the Hastings School of Law at the University of California, said that the Biden administration’s move to issue orders for increased doses is very strange, and that if the US government plans to bypass the regulatory review process, it will be worrying.