The Journal The Authority on Global Business in Japan

The extreme measures being taken around the world to curb the spread of the coronavirus have severely hampered business activity and personal lives. A return to normal likely cannot happen without vaccines or treatment options, so the race to find solutions for Covid-19 is on.

The American Chamber of Commerce in Japan (ACCJ) is home to some of the world’s most innovative biopharmaceutical companies, and on April 30 the ACCJ Healthcare Committee hosted a webinar on the subject.

Entitled Tackling Covid-19: The Biopharmaceutical Industry’s Efforts to Develop New Vaccines and Treatments, the presentation by Dr. James Mayne, vice president of science advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA), provided an overview of the vaccines and therapies in development and explained what it takes to bring a new medicine or vaccine to patients in need—including diagnostic testing, therapeutic approaches, and ongoing research.

DEVELOPMENT
More than 70 vaccine candidates are being explored by multiple entities, Mayne said, and five that are in preclinical testing as of the time of the webinar are supported by, or being pursued in coordination with, PhRMA member companies.

These companies have the experience and capacity to manu­­facture vaccines at the multimillion-dosage level that will be required to truly protect the population and defeat the coronavirus.

There are also six vaccines already in clinical testing that are supported by PhRMA members. These companies have been able to leverage their technology and previous experience with respiratory diseases, such as Ebola and severe acute respiratory syndrome (SARS), to get a head start on countering Covid-19.

Researchers are taking previously utilized and new approaches to unraveling the secrets of Covid-19. Variables include:

  • Administration of medicine
  • Genetic information
  • Stimulation of antibody response

The more attempts made, the more treatments and vaccines can be put into development, and the greater chance of success.

CLINICAL TRIALS
While testing and development are moving at unprecedented speed—at a clip of months instead of years—the safety is of utmost importance. The US Food and Drug Administration (FDA) has issued 45 emergency use authorizations for diagnostic testing. Several PhRMA members are among those who have received a go-ahead.

A typical vaccine development program can take as long as 10 years due to the large amount of data required to certify the vaccine as safe and durable for its intended purpose, Mayne explained. The immunity accorded by a vaccine lasts only for a period of time, and the process of testing involves thousands of patients. Because infectious diseases are often cyclical—they come and go with the seasons—recruitment of patients can take time. That’s one reason clinical trials are often prolonged.

In the case of Covid-19, the global nature of the emergency has forced the timeline to be dramatically compressed. Instead of a 10-year process, we need to get it done in a year or two, he said.

Progress so far has been rapid. It took just 63 days to get through the preclinical phase—virus identification and sequencing, and information dissemination—before the initial trial with the first vaccine candidate began.

Mayne said that vaccine efficacy demonstrations are also proceeding quickly, with the first wave of larger clinical studies expected this summer. There is hope, he believes, that vaccines can be produced and distributed by the end of the year. Again, establishing the safety of any new vaccine is of critical importance, as vaccines are typically administered to otherwise healthy individuals.

The industry has been working closely with the FDA to develop diagnostic methods of testing as well as serological ones, which are performed on a blood sample rather than using a nasal swab.

There are two general types of diagnostic testing underway:

  • Looking for the virus itself
  • Searching for antibodies

In the latter case, a patient who has been exposed to the coronavirus should show signs of antibodies produced by the body. However, it is unclear whether the presence of antibodies confers immunity from further infection.

THERAPY
Significantly more players are involved in the development of therapeutic approaches compared with those pursuing a vaccine, Mayne said.

Several hundred trials are in progress around the world. Therapies being tested include:

  • Antiviral
  • Anti-inflammatory
  • Antimicrobial
  • Immunostimulant

The last of these works by stimu­lating the immune system to enable the body to better fight off pathogens. They may be natural or synthesized, and often are used to induce pro­duction of a specific antibody, as in the case of a vaccine.

Mayne said that existing approved treatments are also being repurposed in hopes that they can slow, inhibit, or degrade the coronavirus’ response and help patients recover.

There are more than 200 clinical trials underway, testing 53 unique investigational therapies from PhRMA member companies. These include:

  • Kaletra (AbbVie)
  • Actemra (Genentech, Inc.)
  • Remdesivir (Gilead Sciences)

Remdesivir has been getting a lot of attention in the United States, and the National Institutes of Health published preli­minary findings about the severe cases. Mayne said that the study was placebo-controlled and consisted of about 1,000 patients. A 31-percent-faster recovery time was observed for those to whom remdesivir was administered relative to those who were given a placebo. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, called this a truly remarkable advance. The FDA is monitoring this data very carefully.

Also being explored are convalescent plasma therapies. These promising approaches use the body’s power to generate antibodies against viral infection, harvest those antibodies, and provide them to other patients. These transfused antibodies may help slow or reduce the disease level in the recipient, and the therapy may serve as a bridge between more facile treatments and vaccines.

HUGE RESPONSE
Without a doubt, the pandemic is a massive global challenge that requires a massive global response. Mayne said that the biopharmaceutical industry’s global ecosystem of varying but collaborative approaches is powerful and precious.

Mayne added that one of the key challenges is identifying the most promising pathways of 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, he said, is that the pharmaceutical industry, governments, and other stakeholders are being proactive rather than delaying capacity buildup until an effective vaccine is discovered.

“We are witnessing and experiencing the research and development ecosystem in all of its glory,” he said in closing. “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 threats.”

Christopher Bryan Jones is Editor-in-Chief of The ACCJ Journal. Originally from Birmingham, Alabama, he has lived in Japan since 1997.
More than 70 vaccine candidates are being explored by multiple entities.