Data included in The New York Times Global vaccine tracker shows 36 vaccine candidates are currently being tested in clinical trials. Nine candidates including Biotech/Pfizer, Moderna, and Oxford/AstraZeneca have all entered Phase 3 clinical trials. At least 15,000 participants are enrolled in Moderna’s Phase 3 trial and from the data collected so far CDC has indicated the vaccine is generally safe and well-tolerated. Pfizer was on track to apply for regulatory authorization and it plans to distribute 100 million doses of the vaccine worldwide before end of the year. A third candidate, developed by Oxford/Astra entered phase 3 clinical trial enrolling 30,000 adults at 80 testing sites across the globe including the site in India. This trial is on pause now as one of the candidates developed an adverse reaction to the vaccine in the UK.
Though adverse reactions are common but to pause a clinical trial in Phase 3 is not common at all. So this is definitely a setback. The vaccine known as AZD1222 uses an adeno virus that carries a gene from COVID 19. This is a novel platform and has not been used previously in any approved vaccines. Meanwhile, Russia and China have already cleared experimental vaccines for limited use before testing was complete.
When a new vaccine is developed it has to withstand the challenges of the skeptics. There is a big anti-vaccination lobby around Europe and America. When there are indications that the vaccine is being fast-tracked and influenced by political deadlines it is not easy to introduce it to the public. To introduce a vaccine in the market it takes time. The shortest vaccine developed was for Mumps and it took 4 years. Political pressure will be high to approve a vaccine and President Trump has said a vaccine is possible by the Nov.3 election and accused the FDA of trying to slow the approval process. The World Health Organization this week cautioned against approving a vaccine unless its full risks and benefits are clear. The WHO has said any vaccine shown to be effective in at least in half the people who get it to gain clearance.
Even as companies are competing to be the first, they must navigate political terrain. It is heartening to hear Pharma Companies plan to pledge a statement that they will not release any vaccines that will not meet the efficacy standards. Public health officials are excited at the companies’ rapid development of vaccines but have grown worried as Mr. Trump began talking about a vaccine that could be ready before Nov. 3. Trump advises having privately called the pre-election vaccine the “holy grail”.
The next biggest ethical challenge would be who gets the vaccine. Most of the rich countries have brought millions of doses. What then happens to poorer countries? How would be the acceptance rate be? As per recent CBS poles, only 21% said they will take the shot and 58% will consider and another 21% said they will never take it. Can we make the vaccine mandator as in a previous judgment Jacobson vs Massachusetts uphold the authority of the State to vaccinate all as it was done for the smallpox vaccination campaign. The world is waiting for the “King Messiah” to be riding upon the white horse with billions of effective and safe COVID 19 vaccines to save the world. SHALOM ALEICHEM.
[Dr. Jacob Eapen, a Medical Director at the Alameda Health System(AHS) and a member of the Board of Directors at the Washington Hospital in Fremont, California. The views expressed are his own.]