The race to have a vaccine against the coronavirus is breaking speed records. Several large laboratories plan to finish clinical studies with thousands of patients in the fall, accelerating compared to the several years that these scientific studies usually take. The latest company to join has been the US multinational Pfizer, which plans to ask its candidate for authorization from regulators in October.
Upon approval, Pfizer and its partner Biontech plan to deliver up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021. Preclinical and clinical data led both companies to choose the candidate. called BNT162b2 to advance trials with up to 30,000 participants, which began in July.
The World Health Organization (WHO) collects in its latest report dated August 20 that 30 vaccines are already being tested with volunteers , of which nine are in phase III or II of these studies, the last stages to prove their safety and efficiency. Additionally, there are another 130 in a preclinical or R&D stage in the laboratory. It is an acceleration effort never seen before. Usually the development of a vaccine exceeds a decade of research, with long periods of analysis at each stage. Due to the health and economic emergency, the private sector and the governments have assumed that there is no time and the deadlines are shortened.
In phase III, the last stage before possible authorization, is the option of the British AstraZeneca and the University of Oxford. At the moment, it is the only company with which the EU has signed a supply agreement for 300 million doses, to which Spain is expected to adhere. It is expected that the first injections can be administered at the end of 2020 and especially from 2021. In this case, it is preliminarily calculated that this is the cheapest alternative, of only a few euros per dose, according to the company itself.
EU purchases
For its part, the German company Curevac , with which the EU is in talks to buy 225 million doses, started phase II in August. In the EU's pre-agreements with other laboratories there are 300 million vials from the Sanofi and GSK consortium and 200 million (expandable to 200 million more) from Johnson & Johnson .
In phase III there is also the candidate of the American company Moderna , which plans to manufacture 1,000 million doses. Up to 30,000 volunteers already participate in their trials. This is one of the companies that the Government of Donald Trump has supported with billions of euros in its Warp Speed program (maximum speed) to guarantee itself 300 million doses before January.
More information
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Another one of the most advanced alternative is that of Johnson & Johnson, through its pharmaceutical subsidiary Janssen , which announced on Friday that it will test its experimental product with 60,000 volunteers from September. Janssen is also together with Moderna in the Warp Speed operation, as well as the projects of Pfizer, AstraZeneca, the American Novavax and that of the consortium formed by GSK and Sanofi, which at the moment is somewhat more behind due to its phase I tests and II will begin in September and phase III will not arrive until the end of the year. In the case of Novavax, phase III will begin in October.
It is very likely that the candidates of these laboratories (some of them are giants of the sector such as Pfizer, Sanofi, AstraZeneca, GSK or Janssen) are the ones that will finally end up being administered in Europe, since they are companies that usually research new therapies under the surveillance of the European Medicines Agency (EMA) , which is the body that has to authorize its marketing after thoroughly evaluating the medical dossiers of each product.
Other vaccines that are also advancing rapidly, but that do not carry out clinical trials in Europe, such as those of the Chinese Sinovac , Cansino and Sinopharm, are much less likely to reach Spain . Similarly, the Russian Sputnik V , developed by the Gamaleya Institute, has fewer possibilities, although propagandistically it was the first in the world to be approved after having tested it on only 38 volunteers. On Thursday, Russian health authorities said they will test the vaccine from the end of the month on 40,000 volunteers initially in Russia, although they plan to carry out the studies in other countries as well.
Despite the enormous business risk, as companies advance in their studies and authorizations, many of them are manufacturing their candidate vaccines in parallel or signing agreements with third parties in countries such as India or China to have millions of vials ready at the moment. in which they receive the marketing authorization.
Fear that Trump will approve a vaccine without evidence for electoral reasons
Pressures Peter Marks, one of the main officials of the FDA (the US Medicines Agency) recently threatened to resign before a working group on the Covid-19 vaccine if there was political pressure for the American regulator to approve a vaccine before the presidential elections in the country, which will take place on November 3. This was confirmed this Friday by Marks himself to the Reuters agency. "I couldn't just sit back and see something unsafe or ineffective going on," says Marks.
Concern. Scientists, public health officials and lawmakers are concerned that the Trump Administration will pressure the FDA to authorize a vaccine. The health department has denied the pressure, although Trump himself has assured that he waits for the first doses before the elections. The FDA has called a meeting of its advisory panel for October 22 with the aim of discussing Covid-19, although it has not detailed what treatments or vaccines it plans to evaluate, according to the Bloomberg agency.