In this two-part article on the drug development process, we are discussing the typical life cycle for developing a new drug and comparing it with the fast-tracked process for releasing COVID-19 vaccine. In Part 1, we looked at a typical lifecycle for developing a new drug spanning anywhere between 12–15 years. In this part of the article, we will discuss the process followed for developing the Covid-19 vaccine.
Drug Development Timeline for Covid-19 Vaccine
- March 17 — Pfizer and BioNTech announced collaboration to co-develop a vaccine.
- April 22 — BioNTech and Pfizer gained approval from German regulatory authority to begin Phase 1 clinical trial. The two companies started Phase 1/2 trials in Germany to examine safety, immunogenicity and optimal dosage testing for 4 initial vaccine candidates. To accelerate Covid-19 vaccine process, all 4 candidates moved in parallel during the Clinical trials phase.
- July 13 — Phase 2/3 trials commenced for safety and efficacy examination for two leading vaccine candidates out of 4, receiving FDA Fast Track Designation.
- July 27 — The. lead mRNA-based vaccine candidate was chosen and Phase 2/3 global study commenced with 43,661 volunteers.
- November 18 — Phase 3 study with 95% effectiveness concluded.
- November 20 — Emergency Use Authorization (EUA) request submitted to FDA.
How were the vaccines made so fast?
In March, when Pfizer collaborated with BioNTech to co-develop a COVID-19 vaccine, the companies had many processes in place due to an existing relationship. Since 2018, they have been collaborating to develop mRNA vaccine technologies for potential influenza vaccines. The already established processes gave the two teams a kickstart in their research and clinical trials phase.
Historically, vaccines have taken years to develop because of many time-consuming steps such as growing ingredients in chicken eggs and conducting clinical trails for each vaccine candidate one after another.
The vaccine from Pfizer and BioNTech uses a new gene-based technology known as messenger-RNA (mRNA). The scientists used the viral genome on the novel coronavirus as a template and started conducting research even before an official case was reported in the US. Also, all 4 vaccine candidates were approved to conduct clinical trials in parallel to expedite the Phase 1/2 trials.
Another factor in accelerating the development of Covid-19 vaccine was the role of regulators around the world in responding and approving phases and tasks in record times, sometimes in real-time to ensure approvals do not slow down clinical trials.
- Pfizer with BioNTech have submitted a formal application to FDA on Friday November 20th, 2020 for an Emergency Use Authorization (EUA) of their Covid-19 vaccine.
- FDA announced an advisory committee of independent experts called the VRBPAC will convene on December 10th 2020 to review the facts and data to advise FDA if EUA can be approved.
- FDA will review the effectiveness, safety and manufacturing of the vaccine. The duration within which FDA will provide their decision is not known yet.
- In case of public health emergencies (such as Covid-19), FDA has emergency authority to issue temporary approvals of medical products. Emergency authorization requires less data and can be done more rapidly than full approvals. FDA has authorized a vaccine in this way in 2005 against anthrax — only once in history!
- The two companies have sent data to regulatory agencies in Australia, Canada, Europe and Japan for authorization, already spending over $2.3 billion in this effort.
- If the vaccine is indeed approved, Pfizer and BioNTech expect to make 50 million doses by the end of 2020, which can help vaccinate 25 million people around the world.
Who’s competing and why are so many companies still trying?
We have heard of two major vaccine announcements this week by different companies:
(1) The two-shot vaccine developed by pharmaceutical giant Pfizer and its German partner BioNTech with 95% effectiveness
(2) The 90% effective vaccine by biotechnology firm Moderna, in partnership with the National Institute of Allergy and Infectious Diseases
Other efforts: As of October 2020, there are 42 Covid-19 vaccine candidates in clinical evaluation around the world, 10 of which have reached Phase 3 trials.
But, why are so many Covid-19 vaccines in development all around the world?
- Not yet known which ones are effective and safe in the long term; the duration until when a vaccine can protect against the constantly mutating SARS-CoV-2 is still unknown.
- Distribution and availability is a huge concern among all governments, pharmaceutical companies and healthcare providers.
- Different population groups may need a different type of vaccine based on age, immunity, pre-existing conditions etc.
I hope you found this two-part article on vaccine development insightful. Please comment below your suggestions on topics you would like to learn more about the healthtech industry.