You would think that the vaccine rollout wouldn’t be so difficult. We had some brilliant scientists who raced against time and developed novel vaccines with technology never used before. Both Pfizer and Moderna used unique mRNA technology. The vaccine is administered into your arm muscle and enters your muscle cells. The mRNA instructs your muscle cells to make parts of the virus, which are expressed on the surface of these cells, that cause your immune system to make antibodies. The vaccine mRNA is destroyed and cannot be transmitted. Both companies had robust data, published and reviewed at the New England Journal of Medicine — with 94 to 95 percent effectiveness, after studying close to 70,000 patients (half got the vaccine and half got a placebo drug). Both companies received emergency use approval (EUA) by the FDA. At this time, both companies are planning to apply for full FDA approval based on similar data six months out. A full FDA approval will mean a greater safety profile for the consumer, as the drug has been studied over a longer period. mRNA vaccines can be produced quickly as they do not require the virus to be cultured, but they need to be stored at very low temperatures to prevent the mRNA from disintegrating. This is where the vaccine story begins to get confusing — while the mRNA vaccines were approved for use almost all over the world, including the Middle East Bloc, Australia, EU, and Mexico, notable holdouts to the vaccine were China, India, and Russia. None of the vaccines approved in these countries have been approved in the U.S. and vice versa. The common thread is that countries or their allies with their own domestic vaccines have rejected the mRNA technology. The reasons given are more or less the same. Pfizer applied for approval to India in December. The application was rejected by the central drugs standard control organization (CDSCO). The exact communication states, “After detailed deliberation, the committee has not recommended for grant of permission for emergency use in the country at this stage.” This was due to the lack of local trials in the country and concern about serious side effects and safety — despite a majority of other countries approving the technology based on the same data. In response, Pfizer withdrew their application. In an about-turn in April, India announced a change in policy under which COVID-19 vaccines that have received emergency approval elsewhere in the world would be fast-tracked in India. This opens the three vaccines approved by the FDA in the U.S. to be open to the Indian people. The change in policy was after a record 185,000 new cases, the highest single-day jump in any country so far. The exact logistic mechanism of the actual delivery of these vaccines remains to be seen. In retrospect, the two months lost could have been used to build infrastructure for vaccine storage and delivery. The two vaccines initially available in India were the adenovirus Covishield and Covaxin, made of killed coronavirus. The regulatory agency that approves vaccines raised more than eyebrows in the scientific community when it gave emergency approval during phase-three trials. While preliminary data from phase-three studies published after the approval process show efficacy of 81 percent, the completed trial has yet to be published in a peer-reviewed journal. None of the five Chinese vaccines have published late-stage trial data in peer-reviewed journals. The surprise in all the chaos has been the SputnikV vaccine, which is similar to Johnson & Johnson and AstraZeneca. A recent analysis of their interim phase-three results in The Lancet showed it to have a 91 percent efficacy. The adenovirus vaccines have been in the news for the small incidence of blood clots. This may all seem very confusing to you, but it does not have to be so complicated. As a species, we have been an abject failure in dealing with a worldwide crisis. We politicize things for money, political reasons and some kind of weird power, even when it kills us in the process. We already have a World Health Organization (WHO). Would it be so difficult to staff it with the best scientists from every country, without any political pressure and follow their recommendation worldwide, without local bureaucratic interference? The first vaccine approved by the WHO — no prizes for guessing — mRNA Pfizer. Humans have a way of complicating life by breaking even common sense into silos guided by politics, power, hubris, and finance. We read history and shake our heads when we see some of the haunting tragedies of mankind. And yet, we continue making the same fundamental mistakes. To paraphrase, “The tragedies will continue; we just will have different entries and exits.” Source
