Originally posted @ TrialSiteNews.com
The Center for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) represents a committee within the federal public health agency that offers up purportedly sound advice and guidance on effective control of vaccine-preventable diseases in the civilian population of the United States. Yesterday TrialSite attended the ACIP to evaluate not only their methods and underlying assumptions but also the results of a decision done via public webcast. In a unanimous decision, fifteen ACIP members voted to add the COVID-19 mRNA vaccines to the agency’s Vaccines for Children (VFC) program. While technically this group of purported primarily scientific and/or medical experts are not political, they are in fact chosen by the U.S. Department of Health and Human Services (HHS) Xavier Becerra and team, an attorney who of course could be considered by at least some as a political appointee who worked his way up the democratic power structure in California, running for state assembly at the tender age of 32. Now with the unanimous vote based on the premise that the COVID-19 vaccines are absolutely safe and effective and that the risk-benefit analysis with the advent of Omicron variant hospitalization numbers absolutely justified the move. The ACIP recommendation goes in front of Director Rochelle Walensky and the U.S. HHS for approval starting today. It’s highly likely that Walensky and the HHS will simply rubber stamp ACIP’s unanimous decision, one that represents a significant milestone in progressing the inclusion of both Pfizer-BioNTech’s BNT162b2 (Comirnaty) and Modera’s mRNA-1273 (Spikevax) in a routine immunization program. The federal government doesn’t directly require local schools to mandate such a vaccine. Laws at the state level may promulgate vaccination requirements for schools, however. A big move, the ACIP committee’s unanimous vote all but ensures that these mRNA vaccines will at some point become part of the routine vaccination program (at least in many states) once they are formally approved for the youngest age cohorts. While states do not have to comply with CDC guidelines, their ultimate avoidance could in some circumstances trigger significant implications—possibly impacting federal funds for public health or even education. The CDC did share some disturbing data involving COVID-19 Omicron hospitalization rates of children which this media delves into along with other important unfolding dynamics.
The internet and news media were abuzz after the decision yesterday. In fact, some Republican-led states announced that at least in their states such guidance wouldn’t be followed in the form of mandated school immunization. For example, Joseph Ladapo, a lightning rod of denigration lately due to his recent study suggesting the risks of the COVID-19 vaccines don’t merit any mandates for young persons tweeted “Regardless of what the CDC votes on whether COVID-19 vaccines are added to routine child immunizations—nothing changes in Florida.”
During yesterday’s session, Dr. Matthew F Daley, the ACIP Work Group Chair, presented the current COVID-19 vaccine status for the bivalent booster that again is just now in clinical trials. On October 12, 2022, the FDA granted emergency use authorization (EUA) for the Moderna bivalent COVID-19 vaccine boosters in children 6 to 18 years of age. The FDA also authorized on an emergency basis for the Pfizer-BioNTech vaccines boosters in children ages 5 to 11 years. Also on October 12, 2022, the CDC recommended the use of updated (bivalent Omicron BA.4/BA.5) boosters in people ages 5 years and older.
What where the activities that the CDC Vaccine Work Group went through over the past month?
First, the group reviewed vaccine safety and immunogenicity data for monovalent Moderna COVID-19 boosters for children aged 6 to 17 years. Second, they reviewed the Novavax COVID-19 vaccine safety and immunogenicity data—specifically focusing on use as a booster for adults aged 18 and up. Third, the group poured through the data involving the COVID-19 epidemiology and outcomes involving persons who are pregnant. Fourth, the Vaccine Work Group delved into the epidemiology and outcomes data associate with infants while fifth, the vaccine safety and effectiveness data associated with the COVID-19 mRNA vaccines and pregnancy, and finally, the effort to review the proposed integration of COVID-19 vaccines into the VFC program. Undoubtedly a major undertaking, the group’s decisions have profound impacts on American society. For those interested in Dr. Daley’s presentation follow the link.
The decision moved to COVID-19, pregnancy, and vaccines. Sascha Ellington, Ph.D., MSPH, CPH of the CPH Emergency Preparedness and Response Team Lead Division of Reproductive Health National Center for Chronic Disease Prevention and Health Promotion at CDC, tapped a large meta-analysis published in The BMJ “Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis.”
Ellington took the other members and public viewers on a tour of pregnancy-related data via multiple sources demonstrating that: A) first and foremost, pregnancy was a risk for severe illness; B) the novel coronavirus is associated with increased risk for material complications and adverse pregnancy outcomes and C) infants born to people with COVID-19 during pregnancy are at higher risks for adverse outcomes. Of course, TrialSite has reported that in regard to pregnancy data the actual FDA labels highlight the unknown risks at this time.
Based primarily on data from the Vaccine Safety Datalink (v-safe) and a national survey called the NIS-ACM: National Immunization Survey-Adult COVID-19 Module-see powered complete and ongoing studies delving into COVID-19 vaccine safety in pregnancy.
The basis for many decisions is based on limited studies including:
Current VSD studies on COVID-19 vaccine safety in pregnancy