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On Vaccines and Vaccinology, In COVID and Beyond | a16z

Check out the a16z Podcast Episode Page & Show Notes

Key Takeaways

  • Over 200 vaccine programs for SARS-CoV-2 have been initiated worldwide
    • “Vaccine development is moving at what we would call lightspeed relative to the standard timeline” – Rajeev Venkayya
    • Methods of “massively” reducing the time required to ensure vaccine safety have been discovered, aiding in this lightspeed development
  • New mRNA vaccines being tested for COVID directly introduce genetic mRNA sequences, which carry the instructions for the virus to make proteins, for the immune system to tackle
    • “The underlying principle is that if you expose the human body to a protein that is on the surface of a virus or in the virus you can train the body to recognize that component and by extension the virus” – Rajeev Venkayya
  • “I think there are going to be multiple COVID-19 vaccines and they are going to have very different attributes” Rajeev Venkayya
  • “The size of the clinical trials that are being conducted for these vaccines are about the same size of trials that we would normally conduct to demonstrate the efficacy and safety of any vaccine. So the bar hasn’t changed there.”Rajeev Venkayya
    • What will be different is the lack of many years of follow-ups to determine the duration of protection and rare long-term side effects 
  • People will be against a COVID vaccine for reasons ranging from false, debunked information to reasonable concerns regarding the accelerated timeline and lack of long term information
  • “If we can show that we can achieve significant equitable distribution of this vaccine it will set the stage for how we do everything in public health and access to medicines for several decades” Rajeev Venkayya
    • Wealthier countries taking up a larger share of vaccines is a historical pattern based on previous vaccine programs

Intro

  • Rajeev Venkayya, M.D. (@rvenkayya) was the former Director of Vaccine Delivery at the Gates Foundation and is currently President of the Global Vaccine Business Unit at Takeda Pharmaceutical Company
  • Host: Jorge Conde (@JorgeCondeBio)

COVID Vaccine Progress

  • Over 200 vaccine programs for SARS-CoV-2 have been initiated worldwide
    • “That of course isn’t enough having a lot of people working on this. You need to have processes, systems, and governmental and regulatory commitment to make things happen quickly.” – Rajeev Venkayya
  • “Vaccine development is moving at what we would call lightspeed relative to the standard timeline”Rajeev Venkayya
    • Normal vaccine development generally takes 10-15 years all the way from the discovery of a potential vaccine to it being available for the pubic
    • “That entire process is being condensed down to 12-18 months”
  • Methods of “massively” reducing the time required to ensure vaccine safety have been discovered, aiding in this lightspeed development
    • This includes technologies which accelerate testing and development and also administrative changes to make the paperwork and licensing process more efficient
  • A lot of money is also going into commercial supplies to prepare for the initial launch of a publicly available vaccine without a vaccine even being ready yet
  • “I think there are going to be multiple COVID-19 vaccines and they are going to have very different attributes”Rajeev Venkayya
    • “It will be the job of recommending bodies that are groups of experts that look at what vaccines are available to make recommendations on what the best vaccines are on a population by population basis” 

General Vaccine Development in Order

  • Preclinical Studies
    • This first step involves researching different parts of the virus to identify proteins which might trigger the necessary immune response in a person
  • Animal Testing
    • The vaccine in development is then tested on animals to get an initial sense of the vaccines’ safety and efficacy
  • Phase 1 Testing
    • In this step the safety for humans and the proper dosage is determined
  • Phase 3 Clinical Efficacy Evaluations
    • Here the vaccine is tested on tens of thousands of individuals then statistically compared to placebo groups to determine whether and to what degree the vaccine is effective in populations

New Vaccine Technology

  • “The underlying principle is that if you expose the human body to a protein that is on the surface of a virus or in the virus you can train the body to recognize that component and by extension the virus”Rajeev Venkayya
    • There are different methods for training the body to recognize these proteins, some of which have been made possible by new technologies
    • “Vaccine development, generally speaking, has not kept up pace with product development in other areas” 
  • The traditional vaccine technology most people think of is introducing dead virus cells into the body for the immune system to fight 
    • Another common method is introducing a weaker version of the virus that doesn’t cause disease, an attenuated virus, so the body also learns to recognize the disease-causing version
  • These new mRNA vaccines being tested for COVID directly introduce genetic mRNA sequences, which carry the instructions for the virus to make proteins, for the immune system to tackle
    • mRNA vaccines have been around as a concept for many years, but none have been approved for human use yet
    • Moderna’s vaccine for COVID is the first mRNA vaccine to reach phase 3 in development

Does The Speedy Development Of The Vaccine Compromise Safety?

  • “The size of the clinical trials that are being conducted for these vaccines are about the same size of trials that we would normally conduct to demonstrate the efficacy and safety of any vaccine. So the bar hasn’t changed there.”Rajeev Venkayya
  • What will be different is the lack of many years of follow-ups to determine the duration of protection and rare long-term side effects  
    • “This is where it is very important that the scientific community and the biopharmaceutical industry be extremely transparent about the data that they’re generating that supports licensure. And then after they license their vaccines that they share on an ongoing basis the safety information on these vaccines so the public is aware.” – Rajeev Venkayya

Trust in Vaccines

  • Jorge anticipates a “neo anti-vaxxer” movement who actually look at anti-vaxxers unfavorably but will advocate against a COVID vaccine due to a lack of information about it
    • “A recent survey suggested that half the population here in the US would be hesitant about taking a coronavirus vaccine when it becomes available”Rajeev Venkayya
  • People will be against a COVID vaccine for reasons ranging from false, debunked information to reasonable concerns regarding the accelerated timeline and lack of long term information
    • “I think the way they need to be addressed is by extreme transparency by biopharmaceutical companies that are developing vaccines, regulatory authorities, and governments” – Rajeev Venkayya
  • “This is very different from giving a medicine to somebody that is dealing with a condition or illness that is causing them suffering where you will accept a different risk-benefit profile than for something that you’re being given to protect you against a theoretical risk”Rajeev Venkayya

Vaccine Investment

  • “One of the challenges in this space from an investment standpoint has been market uncertainty”Rajeev Venkayya 
    • “Your buyer tends to be nations and your buying window tends to be emergencies. When the emergency goes away the nation loses interest and then the market goes away.”
    • Historically, investors in vaccine programs during emergency situations have oftentimes been left holding the bag after the emergency passes
  • “The traditional way you de-risk these types of activities is to have governments and philanthropists come in and fund the R&D” – Rajeev Venkayya
    • The effort being put behind a COVID-19 vaccine is helping to build a platform for future viruses with new procedures and business models being developed

Predictions For COVID Vaccine Success

  • Rajeev is very optimistic about the chances of a vaccine being available because of the promising results coming out of all the late-stage clinical trials
  • “There is one vulnerability that we need to be aware of. Nearly all the vaccine programs that are moving forward at a rapid are focused on the same part of the virus: the spike protein and a portion of that called the receptor-binding domain” – Rajeev Venkayya
    • On the unlikely chance that we were looking in the wrong place we will be in a lot of trouble
  • “I think before the end of the year we will know about the ability of probably more than one vaccine to actually protect people against the virus”Rajeev Venkayya 
    • “The next question is when are we going to have meaningful quantities or volumes of vaccine to immunize people in the US”

Reopening Schools

  • “School reopening should not wait until we have a vaccine”Rajeev Venkayya
    • Many children are at greater risk to their overall wellbeing by staying home
  • “The number one thing that any community can do to make schools safe for reopening is controlling community transmission of virus”Rajeev Venkayya
    • “The other element beyond community transmission is how exactly we’re reopening schools” 
      • Classroom density, mask usage, sanitation efforts, reduced schedule, minimizing mingling in hallways, etc.

Vaccine Nationalism

  • “The question is how can we do this in such a way that does not have the wealthy countries reserving all of the supply from the companies that have the most advanced vaccines in development” Rajeev Venkayya
    • Wealthier countries taking up a larger share of vaccines is a historical pattern based on previous vaccine programs
    • “The tendency of political leaders to protect their own populations first is not unique to the US”
  • The WHO, CEPI, and GAVI have created a program called COVAX which aims to ensure equitable vaccine access by pooling resources to enter into contingent contracts with companies
    • “If we can show that we can achieve significant equitable distribution of this vaccine it will set the stage for how we do everything in public health and access to medicines for several decades” Rajeev Venkayya
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