[ad_1]
By Carl O’Donnell
NEW YORK (Reuters) – Drug makers and research centers around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants underway.
As some companies move closer to releasing their initial findings, with Canadian and European regulators already reviewing early data on some vaccines, here’s what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed more than a million lives:
Who is further ahead?
American pharmaceutical company Pfizer Inc with German partner BioNTech SE, American biotech Moderna Inc and Britain-based AstraZeneca Plc, together with researchers from the University of Oxford, could provide the first analyzes of the data from their various large trials already in October or November. Johnson & Johnson is a little further behind.
What happens in these trials?
The companies are testing their vaccines against a placebo, usually saline, in healthy volunteers to see if the rate of COVID-19 infection among those who received the vaccine is significantly lower than among those who received the sham injection. Neither the trial participants nor the researchers know who received the vaccine or placebo until the data is ready for review or is not blinded. The studies are based on subjects being naturally infected with COVID-19, so the time it takes to generate results depends largely on how widespread the virus is where the tests are conducted. In areas with large outbreaks and community spread, infections will accumulate faster.
How will we know if the vaccine works?
The United States, the European Union, the United Kingdom, and the World Health Organization have established similar minimum standards of efficacy. Vaccines must demonstrate at least 50% efficacy, that is, at least twice as many infections among volunteers who received a placebo than among those in the vaccine group. Independent panels monitor trials to monitor safety and efficacy, as the data is hidden from companies and researchers. These data security monitoring dashboards look at interim results at predetermined milestones, such as after a certain number of people have been infected. If the vaccine looks significantly better than the placebo, companies can request emergency use, and the study can be stopped or continued until its planned conclusion. A trial can also be stopped if the panel determines that the vaccine is unsafe.
Will regulators ensure that a vaccine is safe before making it available to the public?
The US Food and Drug Administration has said it will not approve a vaccine unless it is effective and safe. Earlier this month, he added stricter safety guidelines for American vaccines. The FDA wants developers to follow trial subjects for at least two months after receiving the final dose of the vaccine to detect any side effects that may arise. The agency will consider an emergency use authorization (EUA) once data is collected from at least half of the trial participants. The UK Medicines and Health Products Regulatory Agency will review vaccines for the UK and the European Medicines Agency will review vaccines for use in the European Union.
When will regulators decide?
Regulators will review vaccines after companies have enough data to submit applications seeking an EUA or formal approval. Moderna’s first look at the data is more likely next month. AstraZeneca could provide a look at the data from the last stage in November. Pfizer / BioNtech said it may have data from October, but it will wait for the safety data it expects in the third week of November to present it to US regulators.
Regulators in Europe and Canada are considering the data on an ongoing basis, as it becomes available. Both the UK and the US expect quick reviews of initial data for possible emergency use before longer, traditional reviews for formal commercial approvals.
Could these be the first approved vaccines against the coronavirus?
Yes, although China and Russia are on a similar timeline. China launched an emergency use program in July targeting essential workers and others at high risk of infection that has vaccinated hundreds of thousands of people. At least four vaccines are far off, including those from China National Biotec Group (CNBG), CanSino Biologics and Sinovac. Sinovac and CNBG have said they expect the first test data from November. Russia’s Gamaleya Institute has started a last-stage trial of 40,000 people and is expected to have initial data in late October or early November. Russia has also administered the vaccine to at least hundreds of “high-risk” members of the general population.
Is US authorization up to President Trump?
The FDA must ensure that the benefits of a vaccine outweigh the risks before authorization, as they are intended to be administered to hundreds of millions of healthy people. However, the US Department of Health and Human Services (HHS) has the authority to override the FDA recommendation. President Donald Trump has complained about the new safety guidelines, which delay the availability of any vaccines until after the November 3 presidential election at the earliest. The Trump administration may hire and fire HHS officials, opening up the possibility of political pressure to approve a vaccine.
(Reporting by Carl O’Donnell in New York; Additional reporting by Julie Steenhuysen in Chicago, Michael Erman in New York, Ludwig Burger in Frankfurt, Alistair Smout in London, and Polina Ivanovo in Moscow; Editing by Caroline Humer, Bill Berkrot and Frances Kerry )
