Where are we in the Covid-19 vaccine race?



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By Reuters Article publication time 12h ago

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London – The European Union approved on December 21 the Covid-19 vaccine developed by Pfizer and BioNTech, the latest regulatory go-ahead for the injection, while the United States authorized Moderna’s vaccine on December 19, the second for the country and the first for the company around the world.

Here is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has killed more than 1.7 million people worldwide:

WHO IS FURTHER?

The American pharmaceutical company Pfizer and the German partner BioNTech are the pioneers in the Covid-19 vaccine.

On November 18, they became the first in the world to publish full late-stage test data. Britain was the first to approve the injection for emergency use on December 3, followed by Canada on December 9 and the United States Food and Drug Administration (FDA) on December 11. Several other countries, including Saudi Arabia and Mexico, also approved it. .

The European Medicines Agency (EMA) approved the injection on December 21 and India is speeding up its review.

The World Health Organization could decide whether to grant its emergency use approval to the Pfizer candidate before the end of the year as part of its COVAX program aimed at providing vaccines for poor and middle-income countries.

WHO WILL APPROVE THE NEXT MODERN?

Moderna became a close second to Pfizer in many countries after it released a full data analysis for a late-stage trial on November 30 that showed a 94.1% efficacy rate for its vaccine. Canada approved the vaccine on December 23 and the EMA will do so on January 6.

WHO ELSE IS IN THE RACE?

Britain’s AstraZeneca is seeking approval for its vaccine in Britain after announcing interim data from the last stage of the trial on 23 November. It had an average efficacy rate of 70% and up to 90% for a subset of trial participants who received half the dose first. , followed by a full dose.

However, it is not clear how the regulator will treat the different doses in the efficacy data in its evaluation. While India is conducting an expedited review, it has requested more data. AstraZeneca is also in discussions with the EMA, which is conducting an ongoing review of the vaccine.

India is expected to make a decision on whether or not to approve the full two-dose regimen of the injection, which was shown to be 62% effective in late-stage trials, soon. Their review does not include the most effective dose, 90% effective, which was given to a small subset of volunteers in the trials.

US drugmaker Johnson & Johnson plans to deliver test data in January 2021, preparing it for US clearance in February if its injection is effective. He lowered the enrollment target for his clinical trial to 40,000 volunteers from 60,000 on Dec. 9, which could speed up results that are linked to how quickly participants become infected.

US firm Novavax is conducting a last-stage test in Britain with data expected for the first quarter of 2021. It expects to start a full-scale test in the United States this month.

However, France’s Sanofi and Britain’s GlaxoSmithKline announced a setback on December 11 in their attempts to develop a vaccine. Drug makers said it showed insufficient immune responses in older people in middle-stage trials and that they would start a new study in February.

WHAT HAPPENS IN THE TRIALS?

Companies generally test 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.

HOW ARE VOLUNTEERS INFECTED?

The trials are based on subjects being naturally infected with Covid-19, so the time it takes to generate results is highly dependent on how widespread the virus is where the trials are conducted. Each pharmacist has targeted a specific number of infections to trigger a first analysis of their data.

HOW ARE VACCINES SUPPOSED TO WORK?

The World Health Organization ideally wants to see at least 70% effectiveness. The FDA wants at least 50%, which means there must be at least twice as many infections among volunteers who received a placebo than among those in the vaccine group. The EMA has said it can accept a lower level of effectiveness.

WHAT ABOUT RUSSIA AND CHINA?

While the Pfizer injection was the first to be implemented following the publication of the full data from the phase III trial, Russia and China have been vaccinating their citizens for months with several different vaccines that are still in late-stage trials.

Russia said on Nov. 24 that its Sputnik V vaccine, developed by the Gamaleya Institute, was 91.4% effective according to interim results from the last stage of the trial. It began vaccinating in August and has so far inoculated more than 100,000 people.

India plans to make 300 million injections next year and Argentina has given the green light for emergency use of the vaccine, with some 300,000 doses due to arrive in the country on December 24.

China launched an emergency use program in July targeting essential workers and others at high risk of infection. It has vaccinated around a million people in mid-November using at least three injections, two developed by the state-backed China National Biotec Group (CNBG) and one by Sinovac Biotech.

Trial data on a Covid-19 vaccine developed by China’s Sinovac Biotech has varied: Interim data from a late-stage trial in Turkey showed that its CoronaVac injection is 91.25% effective, while researchers in Brazil say that the injection was more than 50% effective.

Meanwhile, the United Arab Emirates said on Dec. 9 that one of the CNBG vaccines was 86% effective based on interim results from a late-stage trial in the Arab Gulf state.



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