The CDC ACIP (Advisory Committee on Immunization Practices) had an emergency meeting today.
The purpose of this meeting is to update everyone on the current affairs related to COVID19 vaccinations. There were a lot of big wigs in attendance: new CDC Director, FDA, NIH, DOD, HHS, CDC, AAP, ACOG, AMA, CSTE, AAP (just to name a few).
Here are your cliff notes…
• Enrollment ended in the US. 32,459 people enrolled. As of Jan 21, 26,327 trial participants have received their second dose. 57.8% have a comorbidity and 23.6% are 65+ years old. Trial participants are only getting the standard dose (not the half dose that some in the UK received)
COVID19 epidemiology among kids…
• Kids with the most severe COVID19 are in these groups (and in this order): Obesity; Asthma; Immunocompromised; Chronic lung disease; Cardiovascular disease; sickle cell disease; diabetes; cerebral palsy; down syndrome; hypertension, and renal disease.
• 1,659 cases of MIS-C in 47 states, leading to 26 deaths
Vaccines for children…
• Rationale for pediatric clinical trials: 1) Pediatric burden of disease is significant 2) Disproportionate burden among children in minority communities 3) Indirect effects to the child and society (school, development, etc.) 4) Continued burden if we wait for natural “herd” effects 5) Data suggests that vaccination prevents asymptomatic carriage, thus reversing pandemic more rapidly 6) Safety data are best collected in clinical trials
• Age de-escalation trials will be organized as the following: 6 to <12 years; then 2 to < 6 years; and infants to < 2 years
• True placebos (like saline) are being considered. Another vaccine hasn’t been proposed as a control yet
• Will test multiple dose levels (full, half, and quarter doses)
• Safety of COVID-19 vaccines are reassuring and consistent with clinical trials
• We (the U.S.) are actively collecting safety data from three main sources: V-safe (active surveillance), VAERS (passive surveillance), and Clinical Immunization Safety Assessment Project (CISA) (which investigates individual cases).
• V-safe data has been initially analyzed. 2.08M people have participated in V-safe (out of 21.8M people vaccinated). There are 15,131 pregnancies reported to v-safe (they will follow these women that consent up to 3 months after babies are born)
• See the Figure for the reactions to the vaccines being seen in real-time.
• Anaphylaxis: 50 people reported for Pfizer (out of 9.943M doses) and 21 reported in Moderna (out of 7.581M doses). 90% happened within 30 minutes of vaccination. 80% (Pfizer) and 86% (Moderna) of people had a history of allergies
• VAERS has 196 deaths reported following vaccination. None of them have been causally linked to vaccinations.
Other random notes…
• Prior COVID infection and vaccine side effects: they are designing a study to get a better idea of what’s happening
• Vaccine and transmission: This is a priority. 5,000 healthcare providers and first responders are being assessed for transmission after vaccination. They are getting tested weekly for infection.
• Among 65+ years, 90% of vaccine recipients are White. Speed is compromising health equity
• There is no additional data for delayed doses. The current recommendation remains: don’t delay your second dose more than 6 weeks (42 days) after your first dose
• mRNA vaccines are NOT interchangeable unless in an exceptional situation
Okay, now you’re up to date. Phew.
Here are all the presentation slides if you want more: https://www.cdc.gov/vaccines/acip/meetings/slides-2021-1-27-21.html