In late January 2020, Chinese scientists in Shanghai released the fully sequenced genome of the novel coronavirus, which was wreaking havoc in the Hubei province. This kick-started the bio-tech race for pharmaceutical companies and governments to develop a Covid vaccine, bypassing the inverse relation of speed and safety.
The Trump administration announced Operation Warp Speed(OWS), a multi-agency collaboration to accelerate the development of a vaccine.
While excluding partnership with any Chinese vaccine developers and trying to invigorate the non-profiting vaccine development sector, the OWS is now itching close to the finish line, after two of its beneficiaries, Pfizer and Moderna, reported their vaccines with a 90% efficacy rate.
As we roll up our sleeves for the desperately sought vaccines, the incentive for others to speed up their process is growing. Russia and China are already rolling up their vaccines to the population without a valid final test.
Shortly after Pfizer’s breakthrough, Moscow reported a 92% efficacy of the Sputnik-V vaccine while registering and advocating their third vaccine against the virus.
While the pharma giant and a biotech upstart write their applications to the FDA, the important lessons about hazards of rushing a vaccine development program come to us from the calendar of historical precedents where both safety and lives were sacrificed for speed.
Let’s take a guess. And guess what, “Pfizer has a spot.”
Edward Jenner, who is known for his contribution to the eradication of smallpox, had sent samples of the smallpox vaccine to his friend Benjamin Waterhouse.
Waterhouse initiated a vaccination program in Marblehead, Massachusetts (a port located 16 miles from Boston), which was initially free from the virus. In the course of a few months, a smallpox epidemic ripped the town apart, killing 68 people. The vaccine, instead of the cowpox virus, contained the smallpox virus.
In 1901, a horse named Jim in St.Louis, Missouri was used to prepare an antitoxin for diphtheria and had produced many gallons of antitoxin in his career.
However, in October, Jim showed signs of tetanus and was euthanized. The vaccine made in the preceding month was contaminated by the tetanus bacteria as Jim was in the incubation period. This mishap resulted in the deaths of 13 children.
In 1919, an infected Diptheria vaccine killed 10 children and made 60 others seriously ill in Dallas, Texas. The antitoxin had passed the tests of the New York State Health Department.
Sanctioned inoculation of contaminated Diptheria antitoxin in Bundaberg, Australia, led to the deaths of 12 children within hours of vaccination. Improper storage of a multi-use bottle of TAT(Toxin-anti-toxin) was the reported reason for the tragedy.
In Lubeck, Germany, an approved but contaminated BCG vaccine was given to infants. The vaccine contained viable TB bacteria. Around 250 infants received the vaccine, and 75 of them died, and many others contracted TB from the vaccine
Yet, another Diphtheria vaccine tragedy occurred in Japan, killing 84 people (68 Kyoto and 16 Shimane). Batches of Diptheria toxoid administered to babies in Kyoto and Shimane were not properly tested.
By making lakhs of corona vaccine doses available to several countries India has fulfilled its obligation towards humanity in these times of difficulty.
— President of India (@rashtrapatibhvn) January 29, 2021
This led to the deaths of 84 children. Many alleged that PH&W (Public Health and Welfare) accelerated the vaccination program to an unreasonable rate.
The ‘Cutter Incident’ needs no introduction. In 1955, some batches of polio vaccine given to the public contained live poliovirus, even though they had passed required safety testing. 10 children died, 164 developed paralysed, and over 41,000 suffered milder polio after 1,20,000 infected doses were rolled out by the Cutter Laboratories, Berkeley.
In the 1960s, to combat the spread of Measles in the US, the first two vaccines approved were Merck’s live vaccine and Pfizer’s inactivated vaccine. 30-40% of recipients of the live vaccine reported side effects like high fever, and another 30-60% developed a modified measles Rash.
By 1965, cases of a new and abnormal measles-like illness (atypical measles) in children previously vaccinated with the Pfizer vaccine were reported. Around 1.8 million doses of the Pfizer vaccine was given before its discontinuation in 1968.
The Swine Flu vaccination program started in 1976 in the US. Following the mass vaccination program, cases of Guillian Barre Syndrome(GBS) among recipients of the vaccine were reported.
The epidemiological data at the time justified the correlation between GBS and the flu vaccine, and a moratorium on the use of the vaccine was announced in December 1976. NYT published an oped outlining ” political expediency” and “self-interest of the government“, following the suspension of the vaccine.
A UN vaccination campaign to stop the spread of measles and polio turned out to be a nightmare for Syria. Within hours of vaccination, the children became limp and unresponsive, and the ones most affected died before reaching the hospital. 75 were sickened, and 15 died post-vaccination.
The reported reason was Atracurium, which was used as a diluent for the vaccine instead of the standard water-based diluent. The immunization program was suspended following the mishap.
Vaccines are celebrated for their role in fighting diseases, but for that, first, they are subjected to a gauntlet of preclinical and clinical trials to ensure its safety and efficacy, followed by licensure, and finally are manufactured in bulk for distribution.
Clinical trials are human trials typically having three phases and each one testing a larger and larger cross-section of people. The entire process often takes 10 to 15 years, but many covid-19 developers are racing to condense the entire process into about a year’s time.
One way they are doing this is by overlapping the three phases and conducting several different trials at once while ramping up the manufacturing of a vaccine a mod testing. The other is the controversial human challenge trial, which is already set to roll in London by January 2021.
These involve the injection followed by the vaccination of a virus to a healthy person and have the potential to reduce the Phase 3 duration for the front runners and completely replace Phase 3 for the starters.
The advocacy group ‘1 day sooner‘ has already garnered over thirty-nine thousand volunteers for these trials. All the phases are critical to the vaccine development process, and toying with them can lead to uncharted consequences.
If the vaccines against Covid -19 are approved, it will be a watershed moment- and that’s a big “if“. But, for all the optimism, unanswered questions like; will the first vaccine allow us to take off our masks, what levels of side effects are acceptable, who will get the vaccine first, will the FDA wrongly push the virus-like hydroxychloroquine, what will be the duration of the vaccine-induced immunity, how will the poor countries afford the high maintenance costs, how reliable is the novel mRNA technique, and so on, are putting out enough patrol on the ambitious timelines of the vaccines.
An inefficient vaccine may have consequences far worse than the ongoing pandemic, and if we don’t pass muster the first time, there may not be enough public trust left for the next time. After all, a vaccine is only as good as “how many people take it”.