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However, he said the challenge is the nature of the current vaccine products, which so far involve novel technologies. This will make regulators even more conservative in their evaluation and approval. “The easy 12-18 month prediction is an impossible dream, at least by a factor of 2, probably more,” Miller said. Reaching a stage 1 level is not a problem; However, he said the FDA played a major role in a debacle over a vaccine to prevent swine flu virus infections nearly half a century ago. “Of the 45 million people vaccinated against swine flu in 1976, 450 developed a serious adverse reaction, the rare and paralytic Guillain-Barré syndrome. What made the situation even more unfortunate for regulators is that the expected epidemic never materialized, so the vaccine was not necessary, “Miller said.
It is for this reason that the FDA’s vaccine regulation is especially conservative, he continued, and the bar has remained high for approval of vaccines administered to millions of healthy people. According to Miller, the first rotavirus vaccine, RotaTeq, was tested in 72,000 healthy babies, and the first human papilloma virus vaccine, Gardasil, was tested in more than 24,000 people.
Immunologist Adrian Liston, PhD, the group’s senior leader at the Babraham Institute and head of the VIB Translational Immunology Laboratory in Cambridge, England, disagrees with Miller. He said how quickly a vaccine is available will depend on how many thousands of deaths occur in the next 6 months. Liston said Drug issues® that you expect a vaccine to be implemented within the next 12 months and may have more risks than previous vaccines. He said that a vaccine that is only 50% effective and causes minor adverse effects in up to 10% of people may be acceptable.
“It will skip many of the normal safety and efficacy steps, and it will probably be a much poorer vaccine than we are used to seeing, but it will probably be useful. Then, towards the end of 2021, I would expect to see the launch of better vaccines, with higher levels of efficacy and fewer adverse effects. At some point in the future, each child is likely to receive a COVID-19 vaccine as part of their routine vaccination program, but it is much more likely to be a third or fourth generation vaccine, with the optimal properties that we have. . wait, “Liston said.
David J. Prelutsky, MD, medical director and founder of Southampton Healthcare and associate professor of clinical medicine at the University of Washington School of Medicine in St Louis, Missouri, said there are many similarities between the spread of HIV and SARS- CoV-2. You highly suspect that a vaccine will be approved within the next 6 to 12 months. “I think, [as] with HIV, therapeutic agents will be the answer and not a vaccine in the foreseeable future, “Prelutsky said.” There may be a vaccine, but it will take longer to develop. “
