Everything You Need to Know (Now) about the COVID-19 Vaccines.
Nina Harawa, MPH, PhD (UCLA/CDU) Professor of Medicine and Epidemiology Member and Youth Minister, Holy Faith Episcopal Church March 25, 2021
Efficacy
Safety • Three trials phases are conducted. • Vaccine developers then collect the data from phases 1-3 and share with the FDA & the Advisory Committee on Immunization Practices COVID-19 work group. • These independent groups look for: • Efficacy • Safety • Balance of benefits and harms • Type or quality of evidence • Developers apply for emergency use authorization or EUA: to allow use of vaccine prior to full approval when benefits outweigh risks. • Three vaccines have been given EUAs in the U.S. thus far. Operation Warp Speed
How was the process sped up?
1st Some clinical trials combined phases to simultaneously test different aspects of the vaccine. 2nd The high rates of new COVID-19 cases allowed differences in disease risk between those who received the vaccine versus the placebo to be measured quickly. 3rd Resources led to increased research: • Lots of government and private funding + more cooperation across scientific labs nationally and internationally = multiple expensive clinical trials at the same time 4th The U.S. government and others invested in building the manufacturing capacity to produce large numbers of vaccine doses before the findings of phase 3 trials were available. Fast is not necessarily bad
1. All of the regularly required steps were still followed. 2. The criteria for efficacy and for safety remained high. 3. Safety and efficacy data for the vaccines with emergency approval are very strong. 4. Vaccine developers had a BIG head start.
Timeline of mRNA technology and key figures in vaccine development Immigrants and minority racial/ethnic groups were involved in developing the vaccines (Pfizer/Moderna)
Facebook launches Dr. Graham and Dr. Corbett get genetic code for virus to create structure-based First iPhone SARS-CoV-2 vaccine with Moderna
Dr. Kizzmekia Corbett appointed to NIH Vaccine Dr. Katalin Karikó begain studying mRNA SARS-CoV-1 MERS Research Center after years of working on SARS-CoV-2 technology for humans at Temple, then UPenn viruses and vaccines
2000 2005 2013 2017
1990s 2002 2012 2014 2020
Dr. McLellan (UT Austin) and Dr. Andrew Ward Dr. Barney Graham, head of Vanderbilt AIDS Dr. Graham and Dr. Jason McLellan solved way Dr. Karikó and Dr. Drew Weissman created (Scripps Research) figured out coronavirus Vaccine Evalution Unit, recruited as one of to modify RSV virus prefusion spike protein to successful synthetic mRNA delivery system prefusion spike structure founders of NIH Vaccine Research Center allow for successful structure-based vaccine Dr. Graham partners with Moderna for mRNA Dr. Karikó joins BioNTech to oversee mRNA MERS vaccine research
First camera phone Twitter launches @ScrippsSHARCs https://cen.acs.org/pharmaceuticals/vaccines/tiny-tweak-behind-COVID-19/98/i38 while COVID-19 disease has been with us for over a year and researchers have been working on coronavirus vaccine development since SARS-Co-V2 was first identified,
they had also been working on vaccines for similar viruses since 2002 and on mRNA vaccines since the 1990s.
Messenger RNA or mRNA Vaccines Viral Vector Vaccines Adenovirus shell with spike DNA
Human cell spike DNA spike mRNA Cell nucleus
Benefits of Getting Vaccinated for COVID • Vaccination protects you, your family, and your community from symptomatic COVID-19. • Pfizer and Moderna vaccines: ~95% in preventing ANY symptomatic COVID-19. • Johnson & Johnson vaccine: 66% effective in preventing moderate-to-severe COVID-19 infection. All of the vaccines are: • 95%+ effective in preventing COVID-19 hospital admission, and • 100% effective in preventing COVID-19 death • Annual flu vaccines: usually only 40-60% effective
• BOTTOM LINE: • All 3 are >95% effective in preventing COVID-19 hospital admission and death. mRNA vaccine side effects
Which vaccine is best????
• https://www.youtube.com/watch?v=K3odScka55A Summary: Which vaccine is best?
All three vaccines greatly decrease the chances you will get a severe case of COVID-19. There were no COVID-19 deaths for the vaccinated groups in any of the clinical trials.
It’s difficult to compare Pfizer and Moderna against Janssen/J&J effectiveness rates for many reasons. • One reason is that they were tested on different groups of people at different stages of the pandemic. Janssen/J&J vaccines were tested against variant strains in South Africa and Brazil, which Pfizer and Moderna were not. What’s clear is that all three vaccine greatly reduce the risk of getting very ill from COVID-19 You are NOT protected right away! Your body takes time to process the vaccine and Can I choose? respond to COVID-19.
Limited supplies = no or limited ability to choose which vaccine may be available to you
Comparison of the available vaccines
Vaccine # of doses Approved for Time from vaccine to build up immune response (when you are safe after vaccination) 2 doses, Pfizer 16 years and older 2 weeks after the second shot = total of 5 weeks 3 weeks apart* 2 doses, Moderna 18 years and older 2 weeks after the second shot = total of 6 weeks 4 weeks apart* Johnson & 1 dose 18 years and older 4 weeks after the first shot = total of 4 weeks Johnson
*Currently for Pfizer and Moderna, the first shot and second shot must be the same brand.
Were people like me part of the clinical trials? Yes. Over 100,000 people participated in the Pfizer, Moderna and J&J trials. The vaccines were similarly safe for all. Efficacy was also similar. • Adults, at least those 18-95 yrs • Race/ethnicities (among Black, Latino, other communities of color, mRNA vaccines over 95% effective) • Chronic conditions (mRNA vaccines ~90% effective) • People who previously had COVID-19. • Trial sites: All: US; Moderna: Germany, Turkey, South Africa, Brazil and Argentina; J&J: Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the U.S. Race/Ethnicity in COVID-19 Clinical Trials Clinical trials included a broad range of diverse participants
Racial/Ethnic Pfizer Moderna J&J group Hispanic/Latino 26.2% 20.5% 45.3% Black 9.8% 9.7% 19.4% Asian 4.4% 4.7% 3.3% Multiracial 2.5% 2.1% 5.6% American Indian 0.6% 0.8% 9.5% PacificIslander 0.2% 0.2% 0.2% Should I get the vaccine even if I already had COVID-19? Yes. Protection from the vaccine can prolong your immunity. You can wait up to 90 days after infection for vaccination but can receive it as soon as you recover and finish quarantine.
Do I still need to wear a mask after getting the vaccine? Yes. The vaccines protect YOU from getting really sick from COVID-19, but you may still get a mild or symptom-free case and then transmit COVID-19 to others. Continue to wear a mask, watch your distance, wash your hands & avoiding indoor crowds. It is also a moral imperative. Service workers and others do not know whether or not you’ve been vaccinated and should not have to worry about exposure. Should I get the vaccine even if I have . . .
The answer is almost always YES, because people with a variety of health conditions took part in the trials, were protected from COVID-19, and experienced similar side effects and reactions to those without these conditions. These include 100s with each of the following conditions:
• Diabetes (both types) • Chronic Obstructive Pulmonary Disease • Heart disease (COPD) • Stroke • Chronic Kidney Disease (CKD) • Neurological disease • HIV • Cancer • Liver disease • Asthma • Obesity The answer is almost always YES because many greatly increase the risk of bad COVID outcomes. Will the vaccines protect against new mutations? There are 3 major variants that were first discovered in UK, Brazil and South Africa. Pfizer & Moderna appear to work similarly against the UK, much less well against the South Africa variant. J&J: appears to work similarly against the Brazil, but somewhat less well against the variant fro South Afr. How much will it cost? The vaccines have been covered by taxpayer dollars, so they will be free to everyone.
Weighing the Risks: Infection vs. Vaccination
Every million COVID-19 vaccinations ~2-3 serious reactions Every million cases of COVID- ~1-2 hospitalizations 19 infection 1-2 possible deaths, under investigation ~15,000 deaths ~70,000 hospitalizations
Moderna and Pfizer vaccine each reported 10 serious allergic reactions out of 4 million doses (as of 1/23/21) Long-Term Risks of COVID-19
@ScrippsSHARCs
(4 Weeks is even better)
When can we get back to “normal”? That depends on achieving herd immunity. ABC News
• For example: One study found that 4 months after participants received the first dose of the Moderna’s vaccine, they had more antibodies than people who had recovered from COVID-19, just 3-6 weeks previously. Key Takeaways
• COVID-19 vaccines work and are safe but nothing is 100% safe. • Lots of misinformation in social media and word-of-mouth. • COVID does not care what any of us believe. • “Side effects” of contracting COVID-19 disease are far worse than side effects of getting the vaccine.
During this presentation, as we talked about the vaccine: •~44 Americans died of COVID & ~200 were hospitalized - One more Time - Why Consider taking a Vaccine? •The Vaccine was developed because millions of people with COVID-19 infection were hospitalized or died.
•Pfizer, Moderna and J&J vaccines are similar (and great) in preventing COVID-19 Hospitalizations and Deaths
We want to Protect our Communities Community Immunity What is in the vaccine? How does the vaccine work? • Pfizer and Moderna: • The vaccine includes protein (mRNA), fats (called lipids), salt and sugar (preservatives) • mRNA vaccines include instructions that teach your body how to recognize and respond to COVID-19. Then it disappears from your body within 1-2 days. • Like Snapchat • mRNA technology has been studied for over 30 years • Janssen/J&J: • The vaccine is a viral vector vaccine • It is made from an inactivated virus that causes the common cold, and contains a piece of DNA that instructs the body to make the COVID-19 spike protein, which causes your immune system to respond • Do not contain any parts of the coronavirus and cannot cause COVID-19 • Cannot alter your DNA in any way Vaccine Effectiveness: Race/Ethnicity Data Pfizer Moderna So, how do you get the vaccine? Getting an appointment: • Vaccinatelacounty.gov • Residents with disabilities or without computer access can • call 833-540-0473 • 8:00am-8:30pm • 7 days a week for assistance • Your provider. • Pop-up clinics/vaccine events. LA Times: Feb 21, 2021 Vaccine access: WWJD? • When the time comes: make an appointment, show up on time, • Share good info and trusted and get vaccinated. sources. There is lots of • Not showing up, may mean vaccine misinformation out there. goes to waste. • Not making an appointment may • Do not try to game the system, not mean that someone more jump in line, or otherwise use needy gets one. position or influence to get the vaccine for yourself or others. • Assist those who are eligible to get an appointment or get to one. Other Resources
• STOP COVID-19 CA website: https://www.stopcovid-19ca.org/
• COVID-19 Vaccine FAQ in community-friendly language: English and Spanish
• NIH CEAL (Community Engagement Alliance) Against COVID- 19 Disparities website: https://covid19community.nih.gov/
• CDC COVID-19 website: https://www.cdc.gov/coronavirus/2019- ncov/index.html My parting shot Twitter: @Harawa_PhD