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LONDON (REUTERS) – Drug manufacturers 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 already underway.
The following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed more than 1.34 million lives worldwide:
Who is further ahead?
US pharmaceutical company Pfizer Inc and German partner BioNTech released final data from the latest stage of the trial on Wednesday (November 18) that showed their injection was 95 percent effective in stopping Covid-19, the highest efficacy rate yet. now.
The companies are the first to publish the final Phase III safety and efficacy data and plan to apply for an emergency use authorization (USA) in the United States in a few days.
On November 16, another US pharmaceutical company, Moderna Inc, released interim data showing that its vaccine worked in a large late-stage clinical trial with an efficacy rate of 94.5%.
Interim results from the last stage of the Russian Sputnik V vaccine trial published on November 11 showed that the injection is 92% effective.
AstraZeneca said Monday that its Covid-19 vaccine, developed by the University of Oxford, could be around 90 percent effective without serious side effects.
Johnson & Johnson says it is on track to release data this year.
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.
What were pharmaceutical companies waiting for to publish data?
The tests are based on the subjects being naturally infected with the coronavirus, so the time it takes to generate results depends largely on how widespread the virus is where the tests are performed.
Each pharmacist has targeted a specific number of infections to trigger a first analysis of their data.
At the beginning of the trials, infection rates were low. With an increase in infections worldwide in October and November, trial participants became infected more quickly.
Pfizer’s final results were based on 170 cases within its trial that involved more than 43,000 participants.
Moderna conducted its interim analysis after 95 participants developed Covid-19, while the Russia test was conducted after 20 volunteers developed the disease.
AstraZeneca said its interim analysis was based on 131 infections among participants who received the vaccine and those in the control group who received an established meningitis vaccine.
How well are vaccines supposed to work?
Ideally, the World Health Organization wants to see at least 70% efficacy in trials.
The US Food and Drug Administration wants at least 50 percent, which means there must be at least twice as many infections among the volunteers who received a placebo as among those in the vaccine group.
The European Medicines Agency has said it can accept a lower level of efficacy.
When will regulators pronounce on safety and efficacy?
Pfizer / BioNTech plan to submit a US application in the United States in a few days.
Moderna aims to submit an application in the coming weeks once it has two months of safety data on half of the trial participants, as required by the US Food and Drug Administration.
That should happen in the second half of November.
That means the FDA is unlikely to make a decision before December.
AstraZeneca said Monday that it will immediately prepare for regulatory submission of the data to authorities around the world who have a framework in place for conditional or early approval.
Regulators in Europe, Britain and Canada are considering the data as it becomes available.
It is unclear when companies will submit efficacy data or when agencies will make a decision.
Could these be the first widely available coronavirus vaccines?
Yes, although 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 Chinese vaccines are well advanced, including those from the China National Biotec Group (CNBG), CanSino Biologics and Sinovac Biotech.
Sinovac said Nov. 18 that the results of the mid-stage trial showed that its CoronaVac vaccine triggered a rapid immune response, but the level of antibodies produced was lower than in people who had recovered from the disease.
CNBG has said that it expects the first test data from November.
Russia has also administered the Sputnik V vaccine developed by the Gamaleya Institute to 10,000 members of the general population considered at high risk of contracting the virus.
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