Children between the ages of 6 months and under 6 may soon have access to a Covid-19 vaccine that has been submitted to the FDA for emergency use.
The volatility of the number of new cases of Covid-19 since October 31, 2021 has increased significantly in the last six months, with remarkably high and low figures being reported by the Centers for Disease Control and Prevention.
The United States reported a total of 81.17 million cases during the two-year pandemic through April 29, according to the CDC, with 991,030 reported deaths. The number of new daily cases increased from 25,454 on October 31, 2021, to 1.26 million on January 10, only to drop to 9,486 new cases by March 13, and reversed again, with 88,535 new cases on April 27.
The infection rate would probably be much higher if it weren’t for the vaccines and booster vaccines provided by the pharmaceutical companies Moderna (MRNA) – Get Moderna, Inc. Report, Pfizer (PFE) – Get Pfizer Inc. Report & Johnson & Johnson (JNJ) – Get the Johnson & Johnson Report. The CDC reports that 82.5% of people aged 5 and over in the United States have had at least one vaccination, according to its website.
The Food and Drug Administration issued the first authorization for emergency use of a Covid-19 vaccine on December 11, 2020, with the approval to use the Pfizer-BioNTech vaccine for people 16 years of age or older, according to the website of Health and Human Services in the USA. . The FDA has approved Moderna’s emergency use of its vaccine for people 18 years of age and older on December 18, 2020. The federal agency has approved the emergency use of Johnson & Johnson Janssen vaccine for people 18 years of age and older. February 2021.
Subsequently, on May 10, 2021, the FDA amended its authorizations to allow the emergency use of the Pfizer vaccine for adolescents between the ages of 12 and 15, and on October 29, 2021, it authorized the emergency use of the Pfizer vaccine for older children. between 5 and 11 years. However, children under the age of 5 have remained unprotected from vaccines since the beginning of the pandemic.
The street
When will children under 5 receive the Covid vaccine?
Moderna became the first drug company to step forward on April 28 to seek emergency approval for its FDA mRNA-1273 vaccine for children ages 6 months to 2 years and 2 years to at age 6, according to a statement.
“We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children,” said Stéphane Bancel, CEO of Moderna. “We believe that mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our ongoing fight against COVID-19 and will be especially welcomed by parents and caregivers.”
Moderna reported on March 23 that the positive intermediate results of the KidCOVE phase 2/3 study showed a robust response to neutralizing antibodies in the 6-month to 6-year-old age group after a primary two-dose series of mRNA-1273 , together with a favorable response. safety profile. Antibody titers in the 6-month to 23-month-old subgroups and 2-year-olds under 6-year-olds met the statistical criteria of similarity to adults in the COVE study, which met the main objective of the study, the statement said. . .
The previously announced results included a preliminary analysis to support the effectiveness of the cases collected mostly during the Omicron wave, including home testing for Covid-19. When analysis is limited to only confirmed positive cases of SARS-CoV-2 by the central laboratory RT-PCR vaccine, efficacy remained significant at 51% for 6 months to less than 2 years and 37% for 2 years to less than 6 years. years. These estimates of effectiveness are similar to the estimates of the effectiveness of the adult vaccine against Omicron after two doses of mRNA-1273, the statement said.
The application for emergency use for children aged 6 months and under 6 is expected to be completed next week.
How safe is the baby vaccine?
Dr. Paul Burton, Moderna’s medical director, told CBS News’ “Face the Nation” on May 1 that the company will provide all of its FDA data electronically by May 9 so that it can perform its analysis. However, Burton said Moderna had already provided the FDA with the data they needed to begin its study.
Burton was confident that the vaccine would be safe for children 6 months to 6 years of age.
“It simply came to our notice then