After publishing encouraging results, the eyes of the public debate have settled on what could be the first pharmaceutical company to request the formal approval of an inoculant against Covid-19.
The Pfizer occupies the vast majority of news headlines to pandemic Covid-19 from Monday, when it announced its disease vaccine is “effective in 90%”, according to the first interim analysis of its Phase 3.
The figure is notoriously high, taking into account that some specialists had announced that a formula that achieves 60% immunization would already be a positive result to face the pandemic. Efficacy was achieved seven days after the second dose of vaccine and 28 days after the first, Pfizer said in a statement, describing in detail the results of the analyzed information.
Consequently, and given the possibility that it will become the first company to formally request the approval of its vaccine by a regulatory entity, The New York Times prepared a guide with 11 necessary data to know about the initiative.
1- What did the scientists conclude?
The information emerges from the phase 3 trial carried out by the pharmaceutical company with the German laboratory BioNtech. The last tests began in July, with 44,000 participants globally. Half of them received the vaccine, while the rest were injected with a salt-water placebo. The scientists then waited to see which volunteers contracted the disease to determine whether or not the vaccine was effective.
Of all the volunteers, only 94 people have gotten sick. Using a database that shows who received the vaccine and who received the placebo, a group of independent experts – that is, outside of Pfizer and BioNtech – evaluated the results and concluded that the effect is greater than 90%.
2- How encouraging is the result?
Extremely encouraging. The United States Food and Drug Administration (FDA) has indicated that the effectiveness threshold for vaccines requesting emergency approval is 50%. Consequently, if the preliminary results end up being the same as the final ones, the figure will far exceed it.
To contextualize the positive result, the US media noted that the vaccines against influenza (flu) that people usually receive globally are between 40 and 60% effective, given that the virus mutates every year. The measles vaccine, by contrast, is 97% effective.
3- Is the vaccine safe?
So far, drug companies have reported no cause for concern. The testing phases prior to the current one – carried out on fewer people, all of them in good health – are designed to detect potential dangers in the vaccine. At that time, they tested four variants of the vaccine and selected the one that had the fewest mild side effects, such as fever and fatigue.
If it does obtain authorization in the United States, the FDA will monitor its application at the national level to ensure that there are no unforeseen effects in the population. In addition, the volunteers who participated in all the testing stages will be monitored for two years.
4- What needs to be done in the rehearsals?
Testing will continue until 164 people contract COVID-19. Thereafter the study will be considered complete. From the analysis of the data collected until then, the experts will go from having preliminary to complete information.
5- Who will be the first to receive the vaccine?
Pfizer CEO Albert Bourla said 30 to 40 million doses could be produced before the end of the year. Considering that two doses are needed to achieve immunization, the figure would be enough to inoculate between 15 and 20 million people.
The criteria for deciding who will receive these doses have not yet been determined, but the different administrations at the global level have expressed their willingness to prioritize the highest risk groups. These often include residents of nursing homes and who work there, and older people with obesity and diabetes. The United States and Europe have already signed contracts to be the first to receive the vaccines. How to distribute this year’s potential 40 million doses has not been announced.
Pharmaceuticals anticipated that they are in a position to expand production to 1.3 billion doses a year starting in 2021.
6- When could I receive emergency approval?
Pfizer anticipated that it will request it the third week of November, at the end of collecting data from the two months of phase 3 trials. Then the FDA will begin the review process. If there are no inconveniences, it could be awarded before the end of the year.
7- Will it work in older people?
The results still do not allow us to conclude whether immunity will be strong in this demographic. However, there are volunteers older than 65 years among the study participants, so eventually, the information will be known. Preliminary information suggests that the vaccine produces a weaker immune response among older adults, but considering that it is far from conclusive, it is entirely possible that it produces a strong response.
8- And in children?
The initial trials of the pharmaceutical companies did not consider the participation of children under 18 years of age. However, as these progressed, this was no longer the case. In September they began to include adolescents up to 16. And last month they started another with children up to 12 years old. Their plan is to test it on even younger children.
9- Did the vaccine receive funding from the United States government?
In July, Pfizer signed a nearly $ 2 billion contract under Operation Speed ​​of Light, the Donald Trump administration’s effort to produce at least 100 million COVID-19 vaccines in the smallest possible time. However, the agreement is for advance purchase, which implies that the pharmaceutical company does not receive any payment until the vaccines are delivered.
Pfizer did not accept public funding to develop its inoculant. “We have never received money from the United States government or anyone,” Kathrin Jansen, a senior company executive, said Sunday.
10- Does this mean that you can stop using a mask?
No way. COVID-19 continues to advance around the world and currently has a special impact in the United States – on Monday it exceeded 10 million positive cases – and in Europe, where many countries have imposed severe containment measures to mitigate its impact.
Also, the vaccine will not be available to the mass public for several months. And even in that case, there is still no information on whether the vaccine prevents asymptomatic transmission of the virus, nor the possibilities of avoiding serious cases of the disease. As different experts have anticipated, even when the vaccine is widely available, precautionary measures will be necessary until the situation has subsided.
11- What does this mean for the other vaccines that are being developed?
There are currently 10 other vaccines in the last phase of testing. The positive news for these drug companies is also positive for other efforts. Pfizer and BioNtech are using a technique called messenger RNA, which carries DNA instructions for cells in the human body to make certain protective proteins. Moderna, also in phase 3, is using the same modality. And the same is the case for other clinical trials – also in earlier phases – in countries such as China, England, India, Singapore, South Korea, and Thailand.
