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The number of people infected with the new coronavirus, which has been featured in the news, is on the rise.
" According to JNN's summary, so far today, there have been 110,432 people nationwide, surpassing 104,169 people on February 5 this year, setting a new record high. Over 100,000 people for the second consecutive day. The following 13 prefectures set record highs: Aomori (975), Miyagi (958), Yamanashi (481), Shizuoka (2712), Aichi (7269), Kagawa Prefecture (593 people), Kochi Prefecture (427 people), Yamaguchi Prefecture (770 people), Fukuoka Prefecture (6588 people), Kumamoto Prefecture (2752 people), Nagasaki Prefecture (912 people), Kagoshima Prefecture (1701 people), Okinawa Prefecture (3904 people)”
The 7th wave of the new coronavirus is surging, but behind the rapid expansion of the infection is the Omicron strain BA. 5.
*Quoted from National Institute of Infectious Diseases
As you can see from the above figure, the infection prevention effect of existing vaccines is lower than that of BA.2. However, there is no clear difference in the prevention of exacerbation. On the 15th, the government's emergency response headquarters also decided on a basic countermeasure policy to "maintain socioeconomic activities as much as possible instead of imposing new restrictions on movement." "The Omicron strain is the main cause of the epidemic, and the rate of severe cases and deaths has decreased compared to before," he said.
Meanwhile, the FDA has posted the following statement on its website. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-recommends-inclusion-omicron-ba45-component-covid-19-vaccine-booster
The translation will be here. (Please understand if there are any mistakes or stop using machine translation. )
"On Tuesday, an independent expert on the U.S. Food and Drug Administration's Vaccines and Related Biologics Advisory Board announced the current availability of COVID-19 vaccines for boosters for the fall and winter seasons of 2022. met to publicly discuss whether a change in vaccine strain composition is necessary.
The FDA-approved emergency-use COVID-19 vaccine has transformed public health and saved countless lives in the United States and around the world. However, SARS-CoV-2, the virus that causes COVID-19, has recently surged worldwide, and highly infectious variants such as Omicron are also spreading rapidly.
Currently available vaccines have helped mitigate the most severe outcomes from COVID-19 (hospitalization and death), but results from post-licensure observational studies indicate that the effectiveness of primary vaccination remains limited to specific vaccines such as Omicron. has been shown to decrease over time for mutants of Also, while the first booster dose has helped restore Omicron's protective efficacy against serious illness and hospitalization, studies have also shown that the effectiveness of the first booster decreases over time. It has been.
In the United States, FDA-licensed or approved COVID-19 vaccines are guaranteed to meet safety and efficacy standards. If you are currently eligible for a booster, we encourage you to do so.
As fall and winter approach, safe and effective boosters to current and emerging vaccines are critical to prevent the most severe effects of COVID-19. After intensive discussion on June 28, 2022, an overwhelming majority of the Advisory Board voted to include the Omicron component of COVID-19 in the SARS-CoV-2 vaccine that will be used in boosters in the United States from fall 2022. Voted for inclusion.
After the vote, we will offer manufacturers looking to update their COVID-19 vaccines to develop improved vaccines and add Omicron to their current vaccine compositions, while seeking to utilize the best available scientific evidence. It was advised to add the BA.4/5 spike protein component to create a bicomponent (bivalent) booster vaccine. This would make an improved vaccine potentially available in early to mid-autumn 2022.
As this year is expected to be a transitional period for the introduction of this improved booster vaccine, the primary series of FDA-licensed and approved COVID-19 vaccines will be used to prevent the spread of COVID-19 caused by the circulating SARS-CoV-2 strain. We do not advise manufacturers to change vaccines for primary vaccination as this is the basis for protection against adverse outcomes.
Vaccine manufacturers have already reported data from clinical trials with modified vaccines containing Omicron BA.1 components, and we believe that modified vaccines containing Omicron BA.4/5 components may be licensed. In some cases, they advised that these data should be submitted to the FDA for evaluation in advance. Manufacturers are urged to begin clinical trials of improved vaccines containing Omicron BA.4/5 components as the pandemic progresses further.
The FDA is considering the possibility that vaccines may need to be modified to address the circulating variants, and has previously provided guidance to industry on how to do so efficiently. As with all COVID-19 vaccines throughout the pandemic, FDA will evaluate all relevant data to ensure the safety, efficacy, and efficacy of modified vaccines under license or approval to ensure they meet FDA standards. and inform manufacturing quality.
Consistent with our commitment to transparency, the FDA will communicate future plans for licensing or potential approval of COVID-19 vaccine boosters with Omicron components.
FDA, an agency of the U.S. Department of Health and Human Services, supports public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, human vaccines and other biological products, and medical devices. is protecting This agency is also responsible for the regulation of our country's food supply, cosmetics, dietary supplements, the safety and safety of products that emit electron radiation, and tobacco products. ”
A vaccine for BA.4/5 will be available in the fall. What worries me is that the speed of virus mutation is faster than the speed of vaccine development. There is no choice but to thoroughly
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