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There has never been a case in medical history in which a vaccine against a disease was developed within a year after the discovery of the disease itself.
The researchers found that people who were vaccinated with Pfizer against COVID-19 had a much lower incidence of the disease than those who had not – the drug’s manufacturer claims the vaccine is more than 90 percent effective in protecting against the disease. disease.
It is true that these are not yet the conclusions of the peer-reviewed research; are cited in the company’s own press release.
Furthermore, this result does not mean that the vaccine will be launched and distributed immediately: it will still have to overcome a number of bureaucratic hurdles, such as registering the vaccine with the relevant pharmacovigilance authorities.
According to preliminary findings, people become resistant to the coronavirus a week after the second dose of the vaccine, which is given 28 days after the first.
The report was announced as the world affected by the second wave of the COVID-19 pandemic. With the news of this, the European stock markets have pushed up prices and oil prices have risen.
Research progress
The third phase of the clinical trials involved tens of thousands of volunteers who received two doses of the experimental vaccine. A similar number of volunteers were in the control group, who received saline injections instead of the vaccine.
Based on the 94 cases recorded throughout the study, Pfizer concludes that its test vaccine is more than 90 percent effective in protecting against COVID-19.
The next step for this drug manufacturer will be to request the drug regulatory authorities of the interested regions to register the vaccine as soon as possible. Pfizer intends to complete the collection of all the information necessary to obtain such expedited registration approval by the end of this month.
It is estimated that Pfizer will be able to produce between 20 and 30 million units this year. vaccine dose: only 10% will be enough to vaccinate. Americans and the vaccine may not even be exported for some time.
Studies of all drugs, including vaccines, are ongoing after registration and launch: this is the fourth phase of clinical trials to expand knowledge about the product, identify less common side effects, and refine efficacy and other data .
“Today is a great day for science and for all humanity.” Our first COVID-19 phase III vaccine test data set provides initial evidence that our vaccine is capable of protecting against disease, “said Albert Bourla, CEO of the company.
But even after these studies, some unanswered questions remain that can only be answered after long and extensive studies: how long the vaccine lasts and if there are ultra-rare but serious side effects that have not been detected in previous studies.
The effect of this (and other) vaccines in resolving the pandemic will not be immediately felt. In particular, drug regulators will need to review the results of clinical trials. After that, production, logistical and political challenges will have to be addressed: even if all the company’s capabilities are connected only to the production of this vaccine, its initial supply will be very limited. Furthermore, the vaccine should be transported at a stable temperature of -70ºC. It is estimated that Pfizer will be able to produce between 20 and 30 million units this year. vaccine dose: only 10% will be enough to vaccinate. Americans and the vaccine may not even be exported for some time.
This will require a clear selection of who will receive this vaccine first. These are likely to be high-risk or high-risk individuals: medical personnel who come into direct contact with COVID-19 patients and the elderly.
Experts note that even the public vaccination that has been launched will not mean masks can be dropped or large crowds accumulate.
Although the study successfully demonstrated that the vaccine could reduce the severity of COVID-19 symptoms, this did not necessarily mean that it prevented the transmission of serious infections or diseases.
This means that vaccinated people can be carriers of the disease without knowing it, and can be seriously affected if they fall into the 10 ‘ineffective’ percentages; additional longer-term clinical trials should help answer these questions.
A total of 43,538 volunteers participated in the study. They were randomly assigned to one of two groups, one for the study vaccine injection and the other for the placebo (saline). According to the study protocol, its researchers had to count the cases of COVID-19 infection. Once a predetermined threshold was reached, an independent team of experts had to review the data and verify the difference in the chances of infection between those who received placebo and those who received the experimental vaccine.
The primary goal of this study project was to determine whether the study product reduced the risk of COVID-19 infection after two injections. Under the protocol, only those who tested positive for the virus and developed symptoms of the disease would be treated as COVID-19 patients. The infections started counting one week after the second injection.
Long-term data will not be collected for this phase of the study. This means that, at the same time, there will be no answer to such critical questions about the duration of exposure to the vaccine or the side effects that can develop over a longer period of time.
Not the only ones
A total of 176 clinical trials of COVID-19 experimental vaccines are currently underway, and 6 vaccines will reach the third phase of clinical trials by the end of October.
Although Pfizer was the first to cross the line of primary results from phase III clinical trials, other manufacturers are almost behind.
Current leaders include the American biotech company Moderna, the British pharmaceutical giants AstraZeneca in partnership with the University of Oxford, the world’s largest healthcare company Johnson & Johnson, and a small American biotech company Novavax.
Moderna is expected to present the preliminary results of its research in November, and AstraZeneca has committed to presenting its findings by the end of the year. Johnson & Johnson and Novavax are likely to present their research results later this year or early 2021.
In developing the new vaccine, Pfizer has used a completely new technology for research and development of vaccine technologies that has not been tested in practice until now, based on the genetic chain of mRNA (information RNA or messenger RNA ), which only requires the genetic code of the virus itself.
Moderna, the world’s first biotech company to test this type of vaccine in humans, is also developing the mRNA-based vaccine.
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