July 15, 2020 (Part B) - Vaccine Development
Vaccine Development
July 15, 2020 - Part B
There has been so much bad news of late that I’d like to introduce an important ray of hope - vaccines. I will begin with these caveats: First, I am not a doctor or researcher, so I have only an informed layman’s knowledge of this field. Second, as Dr. Fauci said in a recent interview, while clinical trials are ongoing, there never can be a guarantee of if, or when, a safe and effective vaccine will be approved because vaccine development is complex and bumps in the road can be expected.
With those caveats, I will confess I am an optimist, having been persuaded that one or more safe and effective vaccines will be approved and available by the end of 2020 or early 2021. That is the opinion of many public health experts, including Dr. Fauci. You must remember that the greatest minds in the world are focused on vaccine development and they are supported by unlimited budgets. Since the genome of the coronavirus was published in January, an unprecedented effort to discover a cure has been underway.
According to WHO, there are now 155 potential vaccines being developed around the world and 23 are in human trials. You will often hear the names of four of them in coming weeks (Moderna, Pfizer, Oxford Univ./AstraZeneca and Inovio) because they will soon begin Phase III trials. I will discuss Moderna and Pfizer in this post because they seem particularly promising:
(1) Moderna - its vaccine proved safe and effective for 100% of 45 healthy adults ages 18-55 in a Phase I trial, according to the New England Journal of Medicine. A large Phase III trial, involving 30,000 adults of all ages, will begin on July 27 and will be completed in October. So far, the vaccine is said “to exceed all expectations”. If Phase III results establish it is safe and effective, approval is expected in 2020.
(2) Pfizer/BioNTech - earlier this month, Pfizer and its German partner reported very promising Phase I/II trial data showing all trial participants generated antibodies 1.8 times or 2.8 times (depending on the dose) the average of a group of patients who had confirmed prior infections. Phase III trials will begin in July (including participants in Huntsville and Athens, AL) and will end in October. Pfizer has announced it is so confident in its vaccine that it will begin manufacturing doses this summer and will have 100 million doses ready to go by the end of 2020.
In light of the growing anti-vax movement in the U.S. and around the world, public health and pharma communities understand they have to get this right in terms of both safety and efficacy. There are estimates that as many as 25% of Americans will refuse any vaccination, even if safety and efficacy are conclusively established. As in the case of HIV/Aids vaccines, community engagement will be critically important.
The NY Times has a vaccine tracker that is an excellent plain-English tool, which I highly recommend for lay persons like you and me: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html