Biden’s booster plan is thrown into chaos due to regulatory obstruction

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Covid-19 vaccine update

The Biden administration’s plan to implement a wide-ranging coronavirus vaccination boost later this month has fallen into chaos in terms of regulatory approvals, qualifications and logistics, which is the latest blow to its efforts to contain the pandemic.

U.S. health officials Announced last month They plan to provide Americans with another round of Covid-19 jabs starting on September 20. Follow the evidence The effectiveness of some vaccines begins to weaken after a few months.

But there are still two weeks before that date, and the planned booster is hampered by the uncertainty of the plan’s timing and implementation, which put Joe Biden’s government on the defensive.

“Our members have a lot of unresolved issues. People are frustrated that we don’t know the hands that will be processed, and I worry that we will be told on Friday that we must start on Monday,” said executive director Claire Hannan. The Association of Immunization Administrators represents immunization departments across the United States.

The US health agency stated that once the booster is approved, recipients of Pfizer and Moderna mRNA vaccines should receive a third injection approximately eight months after the second vaccination.

But now senior US health officials have warned that from September 20, only Pfizer vaccine recipients may be able to receive boosters, while Moderna recipients may have to wait.

The former official said that the White House announced a September 20 date before it was approved by the US Food and Drug Administration and recommended by the Centers for Disease Control and Prevention, and action was taken.

William Schaffner, a professor of infectious disease at Vanderbilt University and a member of the CDC’s vaccine advisory committee, called the announcement about the booster a “shortcut to the process.”

He told the Financial Times: “These suggestions usually came from the Centers for Disease Control and Prevention and its advisory committee, but they have now been reversed.”

This issue has caused so much tension within the government that two senior FDA officials announced their retirement from the organization’s vaccine department last week.

Allies said Marion Gruber and Philip Krause were disturbed by the way the FDA’s role was weakened in a few months.

The FDA declined to comment on retirement, but a former government official said: “These resignations are shocking. With cases approaching record highs and boosters are about to be launched, their appearance may be the worst.”

Former FDA head and Pfizer board member Scott Gottlieb defended the way the government handled the issue.

He told the British “Financial Times”: “The Trump administration waited for regulatory approval before planning who should get it and how to get its logistical support. Because they did not plan ahead, there were about 50,000 unnecessary deaths. This session The government is trying to avoid this situation.”

The imminent increase in the number of transported and administered doses may put pressure on freight companies, health authorities and hospitals.

Some healthcare workers worry that the chaos of December will repeat itself, when the vaccine site did not have enough staff to manage the injections they were receiving, and millions of doses of vaccine were left in the refrigerator for several weeks.

“Most of these facilities are understaffed and are operating at full capacity,” Hannan said.

Transportation is also a problem. As the U.S. economy recovers from the pandemic, many express companies are already struggling to cope with the low level of staffing and high demand. The planned launch will also coincide with the busy holiday season.

FedEx has shipped about half of the vaccine dose in the United States, but it is struggling to cope with the record number, although Richard Smith, the company’s president of the Americas, told the Financial Times that the delivery of the vaccine will be his company’s ” Highest priority”.

Neither the White House nor the US health department responded to requests for comment on the launch of enhanced injections. But this weekend, government officials admitted that the original plan may have to be scaled back.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CBS on Sunday: “We hope to launch two product candidates in the week of the 20th, Moderna and Pfizer.” “As you can imagine, We will only produce one of them, but the other may soon appear afterwards.”

Although Biden has received high marks for his initial rapid vaccination among Americans who want to get the vaccine this year, since July, many states have hesitated about vaccines as a return of Delta variant-related infections. The door was opened. In the United States, more than 160,000 people are infected every day, and nearly 1,500 people die every day.

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