This vaccine may be approved for vaccination!

Author:Medical community Time:2022.06.17

*For medical professionals for reading reference

Active promotion of new crown vaccines for infants and young children is of great significance to the overall control of the epidemic.

On June 15, local time, the US Food and Drug Administration (FDA) vaccine and the relevant biological product consulting committee (VRBPAC) consistently voted for the MRNA new crown vaccine BNT162B2 for children under 6 months to age than risks. The MRNA new crown vaccine BNT162B2 is used for children under 6 months to 5 years old, and the inoculation group of the new crown vaccine is extended to about 19 million infants and children in the United States. The center (CDC) will be awarded the emergency use right of the vaccine in the next few days.

New crown vaccine in infants and young children is very important

At present, children under 5 years of age have not been approved in the United States, which has caused the new crown to have a serious impact on the hospitalization and long -term healthy growth after the infection of children under 5 years old.

As of May 2022, since the epidemic, a total of 45,000 infected infected infected from children under the age of 5 [1] (of which 24%need to stay in ICU [2], 475 people have died [3], and about 50%may be mutated by Omitron. Caused by [4]), compared with other older children, the number of hospitalizations related to COVID-19 under 5 years of age is significantly higher (Figure 1) [5]. During Omicron's popularity, the hospitalization rate related to children under 5 years old and COVID-19 is 1.6 times higher than children aged 12-17, 5.4 times higher than children 5-11 years old [5]. Considering that the three -dose vaccine will not weaken the effectiveness of preventing hospitalization and severe disease within a few months [6,7], so vaccination will play a vital role in preventing children's hospitalization and severe cases.

figure 1

In addition, children may have some long -term sequelae after infection, and adversely affect children's development and mental health [10]. Children's multi-system inflammatory syndrome (MIS-C) is one of the complications of children's infection with new coronary virus. Generally, severe high inflammatory syndrome occurs at 2-6 weeks after infection, leading to a variety of severe clinical symptoms, 60% of which -70%of patients turned into severe illnesses, causing 1%-2%cases to die [8,9]. Vaccine vaccination will play a positive role on reducing these long -term effects.

Just like other age groups, to ensure vaccination for children from 6 months to 5 years old, they can prevent hospitalization, severe diseases, death, and long -term sequelae.

Latest data disclosure: Children from 6 months to 5 years old have three doses of BNT162B2 safety tolerance, descriptive analysis suggests to prevent the vaccine of OMICRON infection of 80.3%[5]

On June 15, 2022, FDA released the 2/3 test data of Biontech. The study was performed during Omicron's popularity. It mainly evaluated 4,526 children under 6 months to 5 years old. The safety and tolerance, immunogenicity, and validity of 3 μg BNT162B2 were inoculated. In terms of safety, no new security issues were found among the three doses of the subject, and after the third dose was vaccinated, the adverse reactions were mostly mild or moderate, and the duration was short. Adverse reactions are equivalent (Figure 2). In terms of immunogenicity, no matter whether or not the previous infection is, the neutralized antibody GMT (113-139) of Omitron (113-139) has been significantly improved compared to the two doses of GMT (12.8-14.3). The consistency observed by the group (Figure 3). In terms of vaccine effectiveness, descriptive analysis prompts that the three -dose vaccine is at least 7 days after vaccination to prevent Omicron ’s symptoms of infection of 80.3%(Figure 4).

figure 2

image 3

Figure 4

In general, the vaccination of new crown vaccines in infants and young children should be valued like other ages, especially in particular, my country is currently facing the invasion brought by Omitron. According to the new crown pneumonia epidemic prevention and control conference held on April 8, the number of infections in Shanghai accounted for 15%and below the age of 18 and below. Among them, the youngest is only 10 days [11]. With the advancement of vaccination in other ages, the problem of immune gap in infants and young children has gradually exposed. The vaccination of vaccines can reduce the occurrence of hospitalization and severe cases of infants and young children, and at the same time, it plays a positive role in infant development and health. Therefore, the active promotion of the new crown vaccination of infants and young children is of great significance to the overall control of the epidemic.

Reference materials:

[1]HospitalizationsthroughMay 14,2022.CDC COVID Data Tracker.COVID-NET Laboratory-confirmed COVID-19 hospitalizations.Available from:https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalization-network. May 20,2022;Counts computed from rates and population size.[2]Marks KJ,Whitaker M,Agathis NT,et al.Hospitalization of Infants and Children Aged 0–4 Years with Laboratory-Confirmed COVID-19—COVID-NET, 14 States, March 2020 – FEBRUARY 2022.MMWR 2022; 71: 429-436.doi: http://dx.doi.org/10.15585/mmmmm7111e2

[3]Deaths through May 19,2022.CDC COVID Data Tracker.Demographic Trends of COVID-19 cases and deaths in the US reported to CDC.Available from:https://covid.cdc.gov/covid-data-tracker/ #Demographics

[4] Computed by Multiplying Weekly Hospitality Count from CDC Covid Data Tracker by the Biweekly Proportion of Specimens Testing Positive From Covariants.org

[5] VRBPAC-06.122-06.15.22-Meeting-BRIEFING-DOCUMENT-SPONSOR-PFIZER- COVID19- Vaccine- Pediatrics.

[6]Ferdinands JM,Rao S,Dixon BE,et al.Waning 2-dose and 3-dose effectiveness of mRNA vaccines against COVID-19-associated emergency department and urgent care encounters and hospitalizations among adults during periods of Delta and Omicron variant Predominance –Vision Network, 10 States, August 2021-January 2022.mmwr Morb Mortal WKly Rep.2022; 71 (7): 255-63.

[7]artof SY,Slezak JM,Puzniak L,et al.Immunocompromise and durability of BNT162b2 vaccine against severe outcomes due to omicron and delta variants.Lancet Respir Med.2022;[Epub]:S2213-600(22)00170-9 ; Doi: 10.1016/S2213-2600 (22) 00170-9.

Doi: 10.1001/Jamapediatrics.2021.0630.

Early-childhood/index.html

[11] On April 8, 2022, the 147th press conference in the prevention and control of the new crown pneumonia.

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