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FDA批准辉瑞(PFE.US)与Moderna(MRNA.US)新冠疫苗更新版 预计未来几天内上市

The FDA has approved the updated version of pfizer (PFE.US) and moderna (MRNA.US) COVID-19 vaccines. They are expected to be available on the market in the next few days.

Zhitong Finance ·  Aug 22 20:59

The U.S. Food and Drug Administration (FDA) approved the updated version of Pfizer and Moderna's COVID-19 vaccine on Thursday.

According to the Zhìtōng Finance App, the U.S. Food and Drug Administration (FDA) approved the updated version of Pfizer (PFE.US) and Moderna (MRNA.US) COVID-19 vaccine on Thursday, providing new protection for the American people during the surge in virus cases in the summer. The new vaccine targets the KP.2 strain, which is a descendant of the Omicron variant JN.1, although the KP.2 currently accounts for only 3% of all cases in the USA. Pfizer and Moderna expect the new vaccine to be available in pharmacies, hospitals, and clinics across the USA in the coming days.

Pfizer and Moderna stated that compared to last year's vaccine targeting the Omicron XBB.1.5 strain, their new vaccine can elicit a stronger immune response against other prevalent subtypes of the JN.1 strain. Dr. Peter Marks, Director of the FDA's Center for Biologics Evaluation and Research, emphasized the importance of vaccinating with the updated vaccine to prevent the spread of current prevalent variants, considering that people's immunity may be declining.

The Centers for Disease Control and Prevention (CDC) recommended in June that all infants aged 6 months and older should receive the COVID-19 vaccine, with a special recommendation for those aged 12 and above, while allowing children aged 6 months to 11 years to use it in emergency situations.

Moderna CEO Stephane Bancel emphasized that timely vaccination with the COVID-19 vaccine is one of the best methods to prevent severe illness, and encouraged people to consider getting vaccinated for COVID-19 while getting the flu vaccine. The FDA's approval came weeks ahead of last year's approval on September 11, providing timely support for controlling the U.S. epidemic.

Despite a certain degree of growth in the U.S. epidemic during the summer, the arrival of the new vaccine offers hope for epidemic control. CDC data shows that high levels of the novel coronavirus have been detected in wastewater in almost all states, reflecting the widespread spread of the virus in the USA. Although other indicators of the virus are rising, the positivity rate and hospitalization rate are still far below the levels seen at the peak of the epidemic.

The latest data from the CDC shows that the positivity rate of COVID-19 testing increased slightly from 17.9% to 18.3% in the week ending August 10, compared to the previous week. At the same time, the CDC report states that in some specific areas, about 4 out of every 0.1 million residents are hospitalized due to the coronavirus, reflecting a rebound trend in the epidemic in certain regions compared to the lowest point in May when about 1 out of every 0.1 million residents was hospitalized.

It is worth noting that, usually, it takes two weeks after vaccination to trigger an immune response to the virus, which means the decline of the summer epidemic may be related to the timing of vaccination. Federal health officials have long emphasized the need to update the new crown vaccine annually to address new viral strains and the issue of declining immunity over time.

However, it is currently unclear how many Americans will choose to receive another round of vaccines in the coming months. CDC data shows that only about 22.5% of US adults received the vaccine released last fall. Many people say they did not receive the booster shot because they are not concerned about the virus, or because they are too busy to have the time to vaccinate.

In addition, the FDA in June required vaccine manufacturers to produce vaccines against the JN.1 strain, and, where feasible, against the KP.2 strain. This shift poses a challenge to novavax (NVAX.US), which applied for authorization for a new JN.1 vaccine in the same month but has not yet received FDA approval. Novavax is actively collaborating with the FDA and expects its vaccine to be authorized before the peak of vaccination in the United States.

The novavax vaccine is based on protein technology, and compared to the messenger RNA technology used by pfizer and Moderna, the update speed of protein vaccines is slower. Nevertheless, the novavax vaccine can prevent multiple descendant strains of JN.1, including KP.2.3, KP.3, KP.3.1.1, and LB.1.

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