RIO DE JANEIRO, BRAZIL – Nine pharmaceutical laboratories have committed to creating a safe and effective Covid-19 vaccine. The chief executives of these companies have signed an agreement whereby they ensure that the trial and production of the drug will follow “high ethical standards and scientific principles”.
The companies’ announcement comes amid an international race to secure a vaccine that will contain the spread of the coronavirus pandemic and as political pressure increases in the United States in the run-up to the November 3rd presidential elections.
In a statement, the laboratories announced that they will not seek authorization for their respective drugs in any country until it is guaranteed that they are fully “effective and safe”. They further stated that the well-being of patients involved in the trials will be a priority, and that the next steps will be taken based on their ability to produce sufficient doses.
The agreement was negotiated between historical rivals from several countries: Pfizer, Moderna, AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Novavax and Sanofi. “We believe that this commitment will help to ensure public confidence in the rigorous scientific and regulatory processes through which the Covid-19 vaccines will be assessed and ultimately approved,” adds the text signed by the executives.
In recent weeks, US President Donald Trump has sparked debate over how quickly the vaccine will be offered to the public. Trump, with no proof, promised that the drug will be ready before November 3rd, the day he disputes a new mandate. “We will have a vaccine soon, possibly before a special date,” he said last Monday in a press conference at the White House. “You know what date I’m talking about,” he insisted. The president also pressured US officials to expedite the approval process of Covid-19 treatments.
The Centers for Disease Control and Prevention (CDC) advised the states last week that they need to be prepared to distribute the vaccine as early as the last weeks of October and the first days of November. The approval in the USA will fall on the Food and Drug Administration (FDA), which could authorize the use of the vaccine in an emergency. Stephen Hann, FDA director, acknowledged in August that he would be willing to approve the use of the vaccine before the end of clinical trials.
But the laboratories pledged to complete phase 3 of clinical trials – the broadest, involving thousands of participants – before seeking approval from health authorities in any country. The W.H.O. advised on Wednesday that it does not believe the vaccine will reach the world population en masse before 2022.
“The [FDA] agency requires that the scientific evidence for regulatory approval results from large, high-quality, randomized, observer-blind clinical trials, with expectations of appropriately designed trials with a significant number of participants in diverse populations,” the nine companies said. All companies involved are working on the vaccine, although they are at different stages.
Pfizer, in alliance with BioNTech, and Moderna are now in phase 3, testing them on thousands of patients. AstraZeneca suspended its phase 3 trials this week, soon after a patient became ill. Johnson & Johnson’s drug is still in phase 2, while GlaxoSmithKline is in the first phase.
Source: El País