COVID-19 Vaccine Timetable Improves Further

With a wide range of vaccine technologies in development, positive indications of efficacy in phase 2 trials, and production already started, vaccine experts are confident that a COVID 19 vaccine will be available in months, not years. The Wells Fargo Health Care Team recently spoke with John Grabenstein, Ph.D., former Global Executive Director of Medical Affairs for Merck Vaccines. Grabenstein told the team that he was optimistic that vaccine approvals could come as early as the end of 2020 or early 2021, and phase 2/3 data from current trials sometime in the second half of 2020.

With the wide range of established to relatively untested vaccine technologies being trialed, Grabenstein is confident that something will work. The data that he wants to see from early trial results are high levels of neutralizing antibodies, higher than what would be seen naturally after infection with SARS-CoV-2, the virus that causes COVID-19.

In data recently released from Moderna’s phase 1 trial, all trial subjects developed neutralizing antibodies at levels equivalent to above average antibody responses in patients infected with SARS-CoV-2. Another concern raised by studies of antibody production in infected patients is the durability of immunity, many infected patients show declining antibody counts a few months after infection. Grabenstein points out that the antibodies developed in response to a vaccine may not behave the same as those from natural infection due to presence of adjuvants and additional cellular responses.

He pointed out examples of Hepatitis B and yellow fever where antibodies last longer, or individuals with undetectable levels of antibodies still show immunity. He would not rule out the possibility that regular dosing may be necessary.

For production, Grabenstein noted that newer vaccine technologies will have benefits in the rate of production. For example, DNA and RNA vaccines have much higher production yields than adenovirus vectors, inactivated virus, or viral protein-based vaccines. With potential for multiple required doses, this will be important for providing a global supply of vaccine.

Grabenstein could not predict the pricing of the vaccine but mention that JNJ plans to distribute its COVID-19 vaccine on a not-for-profit basis during the pandemic. It is unlikely that there is a price that payers or governments wouldn’t pay for an effective vaccine, but the pharmaceutical industry is under extreme scrutiny for price gouging. If Gilead’s remdesivir is any indication, the precedent may be set for below its medical cost savings. An analysist commenting on the $3,100 price tag of remdesivir estimated it potentially saved $40,000 in ICU care per patient.

In addition to optimism over vaccine progress, medical claims data from IQVIA show continued recovery of elective procedure counts.

For the week ending June 26, elective procedures were down 24% compared with a year ago, however the data is typically delayed and if trends seen in previous weeks, this may actually represent only a 10-15% decline, suggesting the recovery is continuing.

However, as this data comes from over two weeks ago, it is likely out of date in this pandemic world. With weeks of surging cases, followed by increased hospitalizations and now rising daily deaths in the U.S. elective procedures are on hold in many states, especially in the South. In-person visits were down for the week ending July 3 to 31% below 2019’s rate, compared with 19% below for the week prior. This may be due to increased concern in growing case numbers, or due to the July 4 holiday observed on July 3.