The Pharmaceutical Industry’s Role in a COVID-19 Vaccine

The development of a vaccine to counteract the novel coronavirus causing COVID-19 is still in preliminary stages, but already there’s hope. Early data from drug maker Moderna suggests their newest candidate vaccine prompts an immune response by stimulating the body to produce neutralizing antibodies.

In the past, this type of antibody was shown to protect against severe acute respiratory syndrome (SARS), another coronavirus similar to the virus causing COVID-19.

“Currently, there is a lot of pressure on the pharmaceutical industry to accelerate vaccines and treatments that will not only improve hospital capacity but save lives and prevent the virus altogether,” says Dr. Lisa Kennedy, the chief health economist of Innopiphany. “We’re seeing history being made with the development of innovative solutions for COVID-19 virus -these will have wide-reaching and long-term impact, changing how drugs and vaccines are developed.”

The good news is that we’re seeing an unprecedented acceleration of treatments and vaccines exactly when we most need it. Generally, vaccine development takes an average of five years, but current efforts could produce a historical first compressing this time to 12-18 months. This accelerated pace is thanks to the persistent efforts of people working in pharmaceuticals, biotechnology, and medicine.

It is anticipated that an effective vaccine could arrive on the market as early as September 2020. For drug makers, it’s a race against time-current estimates place the number of deaths related to COVID-19 at more than 100,000. By early August 2020, that number could reach as high as 135,000.

While some states are experiencing declines in COVID-19 cases, other areas that have already been hard hit by the pandemic could expect to see considerable increases in diagnoses in the coming months. Many health experts anticipate a “Round 2” of the pandemic later this year that could be even worse than the initial outbreak.

“COVID-19 has been devastating in hot spots like Italy and New York, and this could be much more infectious than we think,” Kennedy says. “Often compared to flu, we are rapidly seeing that COVID-19 is like a year’s worth of flu cases in one week that continues every week.”

Part of preparing for this possible resurgence in cases is the development of a vaccine-however, this process takes time. Vaccine development differs slightly from company to company, but all drug makers must follow the same regulatory process set forth by the U.S. Food and Drug Administration (FDA). Preclinical research lays the groundwork for candidate vaccines, and any promising compounds may be tested using animal models. If the candidate vaccine passes this phase, the company developing the product moves on to clinical trials, which are completed over five distinct phases.

A Phase 1 study using Moderna’s candidate vaccine has already been completed, with eight patients developing neutralizing antibodies at 100 micrograms of vaccine or less. Because of these results, the FDA has already authorized a Phase 2 clinical trial for the same product.

Other pharmaceutical giants, like Pfizer, Sanofi, and GlaxoSmithKline, are also collaborating with biotechnology companies in the hunt for a vaccine. However, these products may not be widely available until 2021.

Drug makers must also determine the standard effective dose at which a new vaccine will work without causing any harm to the person receiving it. This is especially important for vulnerable patient populations, such as senior citizens, since their immune systems may not respond well to vaccination. 

Another consideration to note with the development of a COVID-19 vaccine is the impact it will make on society beyond the aspect of healthcare. Kennedy notes that this economic impact on GDP in Q2 ranges from -20-40%, with some indicating a growth of around 10% in Q3 and Q4 of 2020. The problem, according to Dr. Kennedy, is that there really won’t be a clear view of the economic damage this has had until around July with the effects of stimulus wearing off and greater opening of the economy.

“These estimates may not account for knock effects on consumer spending and more sustained impacts on employment. Some estimate more than $1 trillion in economic impact per month from the virus,” Kennedy says. 

Taking all of this into account, she says the societal value of a viable vaccine in opening the economy “is worth trillions”. Efforts to price this should consider this value while equally balancing this with appropriate patient access. And while there is so much still unknown about the upcoming COVID-19 vaccine, Kennedy says one thing is for certain: “What we can say is that the value of a vaccine is almost incalculable.”