Tackling COVID-19: The Biopharmaceutical Industry’s Efforts to Develop New Vaccines and Treatments

TACKLING COVID-19: THE BIOPHARMACEUTICAL INDUSTRY’S EFFORTS TO DEVELOP NEW VACCINES AND TREATMENTS

THURSDAY, APRIL 30, 2020

ACCJ had the pleasure of hosting James Mayne, Ph.D., Vice President, Science Advocacy, PhRMA, who shared invaluable insights into the efforts being undertaken by the biopharmaceutical industry to tackle COVID-19.

Broadly, Dr. Mayne discussed diagnostic testing, therapeutic approaches, vaccines, and ongoing research.

Diagnostic testing.  The industry has been working closely with the U.S. Food and Drug Administration to develop diagnostic and serological testing.

·      Two types of testing are underway: one looks for the virus itself, while the other searches for the formation of antibodies in patients exposed to the coronavirus.

o   It is unclear whether the presence of antibodies confers immunity from further infection.

·      The U.S. FDA has issued 45 emergency use authorizations for diagnostic testing.

Vaccines.  At the time of this webinar, over 70 vaccines are being explored by multiple entities.

·      Five vaccines in preclinical testing are supported by or being pursued in coordination with PhRMA member companies.  These are companies with the experience and capacity to manufacture vaccines at the multimillion dosage level.

·      Six vaccines in clinical testing are supported by PhRMA members, capitalizing on their technology and previous experience with respiratory diseases such as Ebola and SARS.

·      Several previously utilized and unique approaches, as well as new options, are being explored to develop a COVID-19 vaccine.  Variables under consideration include the administration of medicine, genetic information, and how to stimulate an antibody response.  The more attempts, the more vaccines we can put into development, thereby increasing our chances of identifying successful vaccines.  Multiple vaccines will be needed to support a global scale response.

·      While testing and development are proceeding ahead at unprecedented speed (months instead of years), the safe performance of vaccine products is of utmost importance, as vaccines are typically administered to otherwise healthy people.

Therapeutic approaches.  When it comes to investigational treatments, there are significantly more players compared to those engaged in new vaccine development. 

·      Globally, there are several hundred trials in progress, testing unique therapies such as antiviral, anti-inflammatory, immunostimulant, and antimicrobial therapies.  Existing, approved treatments are being repurposed in hopes they can slow, inhibit, or degrade the virus's response and contribute to patient recovery.

·      Over two hundred clinical trials are testing 53 unique investigational therapies from PhRMA member companies, including AbbVie’s Kaletra, Gilead’s remdesivir, Genentech’s Acterma.

·      There is also research into convalescent plasma therapies, a promising approach that uses the body's power to generate antibodies against virus infection, harvest those antibodies, and provide them to other patients to help slow or reduce their disease level.  This path may serve as a "bridge" between real treatment and a vaccine.

Our global ecosystem of varying but collaborative approaches is powerful and precious.

·      This pandemic is a massive global challenge and, as such, requires a massive global response.

·      We are witnessing and experiencing the research and development ecosystem in all of its glory.  The coronavirus has demonstrated the strong connection among the biopharmaceutical industry, governments, regulators, investors, and willing patients.

·      It is of great comfort that this ecosystem exists, and we must do all that we can to preserve it and maintain its preparedness to ensure we can respond to current and future powerful disease threats.

Questions & Answers

Typically, what goes into vaccine development, and how long does it take?  How does that process compare to efforts surrounding COVID-19?

·      A typical vaccine development program can take as long as ten years due to the large amount of data required to certify the vaccine is safe and durable for its intended purpose – that the immunity accorded by the vaccine lasts for a period of time.  It involves thousands of patients, but infectious diseases often have a cyclical, seasonal nature that complicates patient recruitment, prolonging clinical trials.

·      The global emergency has dramatically compressed the timeline, transforming a ten-year process into one or two years. 

·      The preclinical phase (virus identification and sequencing, and information dissemination) only took 63 days before conducting an initial trial with the first vaccine candidate.  Vaccine efficacy demonstrations are also proceeding quickly, with the first wave of larger clinical studies expected this summer.  There is hope that limited amounts of the first successful vaccines can be produced and distributed by the end of the year.

·      What is remarkable about this progress is although pharmaceutical companies know that only one in ten vaccines developed emerges as a viable product, they are building the manufacturing infrastructure at risk and in anticipation of potential success.

Will the mutations or multiple strains of coronavirus affect the development of antiviral and therapeutic solutions?

·      Although there are multiple strains distinct to specific regions, COVID-19 appears to be relatively stable with less frequent mutation in its viral genetic information compared to other types of viruses (e.g. influenza virus).

How is the industry preparing to manufacture and distribute therapies around the world once companies have demonstrated a vaccine’s efficacy?

·      Important discussions about opportunities to partner, share, and coordinate manufacturing capacity are taking place around the globe.

·      One of the key challenges is identifying the most promising vaccine candidates among the numerous trials, forming the requisite infrastructure, then refining and finalizing the production capability to generate and distribute the vaccines that proved successful.

·      The good news is that the pharmaceutical industry, governments, and other stakeholders are being proactive rather than delaying capacity buildup until an effective vaccine is discovered.

Looking at the current market, how are companies justifying investments in vaccines or therapies?

·      I can tell you from personal experience that these men and women are very personally committed to the importance of this purpose and do not see this as a business opportunity or proposition.  It is our scientific responsibility.

·      The biopharmaceutical industry has been able to respond as rapidly as it has because of the ecosystem that has been cultivated, bolstered by the accumulated knowledge through other historic epidemics and infectious disease challenges.

Is antibody testing in the U.S. geared toward coronavirus detection or the discovery of antibodies?  How will antibody testing impact the reopening of the economy?

·      I wish I knew the full answer.

·      Only a few of the numerous antibody tests have been reviewed and somewhat endorsed by the FDA.  The range of testing makes it difficult to determine the predictability and reliability of antibody testing.  Moreover, the presence of antibodies alone does not guarantee that an individual gained immunity to the virus.

Can you expand on what is happening with remdesivir in the United States?

·      There are many ongoing studies, but two of the most consequential were initiated early and in partnership with the National Institutes of Health.  They are relatively large studies where one looked at hospitalized patients with advanced, severe cases, and the other looked at mild to moderate cases.

·      NIH published preliminary findings about the severe cases, which was placebo-controlled and consisted of a thousand patients.  They observed, relative for placebo, a 31% faster recovery time – a truly remarkable advance, according to Dr. Anthony Fauci.

·      The FDA is monitoring these data very carefully.  It is likely we will hear more shortly about remdesivir's path to approval for patient use. (post meeting note:  Remdesivir was granted Emergency Use Authorization by FDA shortly after the webinar)

Do you think the BCG vaccine may improve resistance against coronavirus, given how some countries have had a slower rate of infection?

·      Some have observed that children with the multi-use vaccine may be less susceptible to COVID-19, hypothesizing that a less-specific vaccine like BCG may stimulate the immune system and potentially offer more resistance over someone who has not received it.

·      The theory requires more data, but it is worth further evaluation.