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Efficacy expectations have been exceeded
Vaccination expectations have certainly been more cautious so far. The US pharmaceutical authority Food & Drug Administration had established a 50% efficacy criterion to authorize them, the European Ema and the WHO said they were satisfied with even lower percentages. The findings from Pfizer and BioNTech are on par with the best vaccines for children, such as the one that prevents measles, rather than the anti-flu which is still 40% -60% effective.
Production and distribution challenges
Even faced with a possible tipping point, the campaign against the coronavirus remains long and with open challenges regarding the production and distribution of the same vaccine. Pfizer and BioNTech have indicated that they could produce 50 million doses, enough to immunize up to 25 million people, by the end of the year, with 1.3 billion doses in 2021. They recently signed a nearly two billion contract with the United States government. United to supply one hundred million doses. Along with that of production, there is the logistical unknown: Pfizer’s vaccine requires very low temperatures for storage and transport. The US administration has envisioned a use of the military to facilitate complex distribution, but it has yet to be implemented. Finally, in the path of mass vaccination, “no-vax” skepticism arises, fueled by the politicization of the fight against the pandemic that has led sectors of the population to minimize it or suspect the medical authorities.
An independent journey
Certainly, if the success that has emerged in clinical trials continues, it is the path that has brought Pfizer to the fore. He was particular and particularly independent in hunting the vaccine. Vice President Mike Pance called the result an effect of the public-private partnership created by the Trump administration. But Pfizer did not take government funding from the Trump administration for the investigation, instead saying it wanted to distance itself from the federal Operation Warp Speep that incentivized companies precisely to avoid entanglement in politics and possible interference in its investigation. He had pledged $ 2 billion of his own capital, engaging in aggressive experimentation that had at times sparked criticism and fears of excessive rush for business or political reasons. Pfizer had not even remained immune to pre-election controversy: it had been suspected to the last of wanting to announce results on the eve of the US vote, an October surprise that could influence the polls in favor of Trump; finally, the provisional result of his studies was announced a week later. In the last hours, the company’s top management reiterated that the timing of the announcement had nothing to do with politics.
Pfizer and BioNTech
The two partners in the vaccine race have very different histories, in a pharmaceutical sector in recent years transformed by mergers, driven by technological innovations, the need to act in global markets and bet on the research and development of new successful products. Precisely the need and urgency to deal with the virus brought them closer and convinced them to combine their respective resources. Pfizer has a long history in the pharmaceutical industry, founded in 1849 in New York, and is still among the largest pharmaceutical companies in the world and the largest US corporations. Among its products, which have covered several areas over the years, are Lipitor against cholesterol, the antibiotic Zithromax, Viagra for sexual difficulties, the anti-inflammatory Celebrex. He also has a long experience in vaccines and in large clinical trials in general. In the summer, however, he left the Dow Jones stock index, replaced by Amgen, a symptom of open problems in future strategies also from industry leaders. In the last quarter, the third of 2020, it beat the profit forecasts, but slightly disappointed the billing, which fell 4.5% to 12.1 billion. BioNTech, for its part, was not founded until 2008 and is a German biotechnology group, specializing in the new frontier of immunotherapies for serious diseases, from tumors to infectious diseases. In 2019 he achieved his profile with an agreement with the Bill and Melinda Gates Foundation for HIV and TB programs. And this year it has raised new investment from several holding companies, including Singapore’s Temasek. The pact with Pfizer for the coronavirus has allowed it to take a new qualitative leap.
The scientific calendar
From a medical and scientific point of view, the next steps for the possible neovaccine against the pandemic now involve a detailed publication of the clinical studies for independent scrutiny. The Pfizer study has enrolled nearly 44,000 volunteers worldwide and is expected to continue until it has examined 164 infected patients. However, the company had anticipated preliminary results, now revealed and that they saw immunity 28 days after the initial dose and seven from the second. A prescribed observation period of two months for the first group of patients, to fully check the efficacy and side effects that currently do not exist, will end in the third week of November. At that point, an emergency request for the use of the vaccine will be activated. The other vaccines Pfizer and BioNTech are not alone in accelerating research at record rates. At least three other vaccines are in an advanced stage of testing. Moderna uses the same innovative technology that Pfizer has used, the messenger named Rna (mRna), where genetic instructions are sent to cells that generate immune responses. Johnson & Johnson and AstraZeneca are the remaining major Western players. China and Russia have called for vaccines, amid doubts about transparency.
