COVID-19 Vaccine Update

Wafaa El-Sadr, MD, MPH, MPA

ICAP at Columbia University

January 19, 2021

 Vaccine Candidates Development

Image source: New York Times

How were vaccines developed so quickly?

• Vaccine developers had a head start

• Years of advanced research had been conducted on related coronaviruses that cause SARS (evere acute
respiratory syndrome) and MERS (Middle East respiratory syndrome)

• No short-cuts were taken

• No steps in the typical vaccine development process were skipped. Rather, they occurred in parallel.

• Manufacturing/ infrastructure development occurred simultaneously

• Factories for manufacturing, distribution centers, etc. were built as the trials were happening

• Enormous interest in COVID-19 vaccines motivate rapid enrollment

• Existing processes for emergency use authorization (EUA) were utilized
• The FDA EUA process requires decisions to be made according to science and data that has been
carefully reviewed by independent bodies
Who participated in the vaccine studies
Pfizer/BioNTech Vaccine Study Moderna Vacine Study
Characteristic Percent Characteristic Percent
Female 49.4% Female 47.4%
Race/Ethnicity Race/Ethnicity
White 82.9% White 79.4%
African American/Black 9.3% Black or African American 9.7%
Latinx 28% Latinx 20.0%
Asian 4.3% Asian 4.7%
Age Other 2.1%
16-55 years 57.8% Age
>55 years 42.2% 18 to <65 years 74.7%
Obesity 35.1% 65 years and older 25.3%
Co-morbidities 52.9% One high risk condition present 22.3%
Two or more high risk conditions 4.0%
present

Polack et al, NEJM 2020

Sciencenews.org
 Efficacy, Safety, and Dosing for Pfizer/BioNTech and Moderna Vaccines

Pfizer-BioNTech Vaccine Moderna Vaccine

Efficacy 95% effective at preventing symptomatic Efficacy 94.1% effective at preventing
COVID-19 symptomatic COVID-19

Safety No serious safety concerns reported Safety No serious safety concerns reported
Most common side effects: Mild-to- Most common side effects: Mild-to-
moderate pain at the injection site, moderate pain at the injection site,
fatigue, headache fatigue, headache

Dose Dose
Regimen Regimen

Source: New York Times

Moderna Vaccine: Efficacy by Subgroup
What are most common side effects– Pfizer/BioNTech
Why receiving two vaccine doses is important?
Pfizer/BioNTech Vaccine

Neutralizing Antibodies Neutralizing Antibodies

(18-55 years) (65-85 years)
 Vaccine Safety Monitoring (US)

• Active surveillance: Side effects reported by vaccine recipients:

• Passive surveillance: Side effects reported by healthcare

professionals, vaccine manufacturers, and the public:

Source: CDC
Allergic Reactions After First Dose of Pfizer-BioNTech Vaccine

• During December 14–23, 2020, monitoring by VAERS detected 21 cases of anaphylaxis

after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19
vaccine (11.1 cases per million doses)
• 71% of these occurred within 15 minutes of vaccination

Source: CDC MMWR (6 Jan 2021)

 Priority Groups for Vaccination

Higher Risk for infection and COVID-19
• Health care workers
• Essential workers: grocery, transit workers,
meat processing plants, others
• Race/ethnic groups
• Congregate settings: long term facilities,
homeless persons, prisons/jails
Higher Risk for complications of COVID-19
• Older age
• Co-morbid conditions: diabetes, heart disease,
obesity, lung disease, hypertension
• Pregnancy

Image sources: Freepik

Achieving Vaccine Impact: Need for High Coverage + and High Efficacy

Efficacy
Quality

+
Coverage
Utilization
Impact
Health

Adapted Margaret Kruk 2013

Continuum of Vaccine Acceptance

CDC, 2020
Interventions to Enhance Vaccine Acceptance

Wood and Schulman, NEJM, 2021

Unanswered Questions/Ongoing Research

• Prevention of SARS-CoV-2 infection

• Durability of protection
• Efficacy after 1 dose
• Safety for children
• Safety for pregnant and breastfeeding persons
• Efficacy and safety in immunosuppressed
individuals
• Efficacy and safety of combining different types of
vaccines
Preventive Measure Post-Vaccination
• Protection from vaccine is not immediate
• Duration of protection unknown
• No vaccine is 100% effective
• No information with regards to effect of the vaccine on
prevention of infection
All individuals, including vaccinated persons should continue to:
• Wear face covering/mask
• Stay at least 6 feet away from others
• Avoid crowds
• Wash hands often
• Follow quarantine guidance after exposure to COVID-19
• Follow any local guidance