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Delta病毒来势汹汹,辉瑞(PFE.US)寻求美国批准第三剂加强针

Delta virus is coming, PFE.US (Pfizer) seeks US approval for a third dose of booster needle

智通財經網 ·  Jul 12, 2021 14:30

PFE.US (Pfizer) will meet with U.S. federal health officials as early as Monday to discuss the need for COVID-19 vaccination, Pfizer said on July 11.

Last week, Pfizer and its partner BioNTech (BNTX.US) announced plans to seek regulatory approval for a third dose of COVID-19 vaccine in the United States and Europe. They pointed out that the COVID-19 variant of Delta increased the risk of infection, and that the data showed that novel coronavirus's risk of infection increased six months after the first vaccination, so it was necessary to receive a third dose of vaccine as a strengthening shot.

Mikael Dolsten, head of research and development at Pfizer, said in an interview last week that the company had obtained preliminary data from early human trials, showing that a third shot to strengthen the injection is safe and can raise neutralizing antibody levels to five to 10 times that of two injections. He stressed that data from Israel and the UK show that even if antibody levels drop, the effectiveness of the vaccine for critical protection remains around 95%.

On July 5th, the Israeli Ministry of Health said that the effectiveness of Pfizer / BioNTech's Delta COVID-19 vaccine had decreased by about 30 per cent, to 64 per cent from 95 per cent in May, due to the spread of the mRNA mutant strain.

The US FDA and CDC responded quickly a few days ago by saying that Americans do not need to strengthen needles yet. Later, a Pfizer spokesman said the company plans to meet with representatives of FDA on Monday.

In addition, Pfizer will hold a briefing with the director of the National Institute of Allergy and Infectious Diseases (Anthony Fauci), the director of the National Institutes of Health and the director of CDC.

Fauci said in an interview on Sunday that U.S. health officials did not rule out the need for enhanced vaccination in the future, especially in the case of breakthrough infections in people who have been vaccinated, but more data are needed before a formal decision can be made.

The translation is provided by third-party software.


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