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Health And Family

Moderna COVID-19 vaccine enters final stage trial this month

Issam Ahmed - Agence France-Presse
Moderna COVID-19 vaccine enters final stage trial this month
In this file image obtained March 12, 2020 courtesy of The National Institutes of Health(NIH)/NIAD-RML shows a scanning electron microscope image of SARS-CoV-2 (round blue objects) emerging from the surface of cells cultured in the lab, SARS-CoV-2, also known as 2019-nCoV, the virus that causes COVID-19, isolated from a patient in the US.
AFP/National Institutes of Health, Handout

WASHINGTON, United States — The US biotech firm Moderna said Tuesday it would enter the final stage of human trials for its COVID-19 vaccine on July 27, after promising early results were published in an influential journal.

The Phase 3 trial will recruit 30,000 participants in the US, with half to receive the vaccine at 100 microgram dose levels, and the other half to receive a placebo.

It is designed to show whether the vaccine is safe and can prevent infection by the SARS-CoV-2 virus, or — if people still get infected — whether it can prevent the infection progressing toward symptoms. 

If they do get symptoms, the vaccine can still be considered a success if it stops severe cases of COVID-19.

The study should run until October 27, according to its page on clinicaltrials.gov.

The announcement came after the New England Journal of Medicine on Tuesday published results from the first stage of Moderna's vaccine trial, which showed the first 45 participants all developed antibodies to the virus.

Moderna, currently in the middle stage, is considered to be in a leading position in the global race to find a vaccine against the coronavirus, which has infected more than 13.2 million people and killed 570,000.

China's SinoVac is also at Phase 2.

Russian news agency TASS on Sunday announced Russian researchers have completed clinical trials on a vaccine, though they have not shared their data.

Scientists caution that the first vaccines to come to market may not be the most effective or safest.

'Encouraging' results

Moderna had previously published "interim results" from the first stages of its trial, called Phase 1, in a press release on its website in May.

These revealed the vaccine had generated immune responses in eight patients, a result called "encouraging" by Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, which is co-developing the vaccine.

But some in the scientific community said they would reserve judgment until they saw the full results in peer-reviewed form.

According to the new paper, 45 participants were split into three groups of 15 each to test doses of 25 micrograms, 100 micrograms and 250 micrograms.

They were given a second dose of the same amount 28 days later.

After the first round, antibody levels were found to be higher with higher doses. 

Following the second round, participants had higher levels of antibodies than most patients who have had COVID-19 and gone on to generate their own antibodies.

More than half the participants experienced mild or moderate side effects, which is considered normal. 

The side effects included fatigue, chills, headache, body ache and pain at the injection site.

Three participants did not receive their second dose. 

They included one who developed a skin rash on both legs, and two who missed their window because they had COVID-19 symptoms, but their tests later returned negative.

"The results look pretty good and look pretty consistent," David Lo, a professor of biomedical sciences at University of California Riverside told AFP.

But he cautioned that more work was needed to evaluate the vaccine's safety — including making sure that it did not backfire by eventually making the immune system "tolerant" toward the real virus.

Amesh Adalja, an infectious diseases specialist at Johns Hopkins University, added it was encouraging that the participants developed high levels of an advanced class of antibodies.

He added, however: "You have to be very limited in how much you can extrapolate from a phase one clinical trial, because you want to see how this works when a person is exposed to the actual virus."

The Moderna vaccine belongs to a new class of vaccine that uses genetic material — in the form of RNA — to encode the information needed to grow the virus's spike protein inside the human body, in order to trigger an immune response. 

The spike protein is a part of the virus that it uses to invade human cells, but by itself the protein is relatively harmless.

The advantage of this technology is that it bypasses the need to manufacture viral proteins in the lab, shaving months off the standardization process and helping to ramp up mass production.

No vaccines based on this platform have previously received regulatory approval.

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As It Happens
LATEST UPDATE: January 26, 2023 - 12:04pm

Follow this page for updates on a mysterious pneumonia outbreak that has struck dozens of people in China.

January 26, 2023 - 2:01pm

The number of daily COVID-19 deaths in China has fallen by nearly 80% since the start of the month, authorities have said, in a sign that the country's unprecedented infection surge may have started to abate.

A wave of virus cases has washed over the world's most populous nation since Beijing abruptly ended its zero-COVID policy last month.

Beijing's figures are believed to only represent a fraction of the true toll, given China's narrow definition of a COVID death and official estimates that swathes of the population have been infected.

The CDC last week said nearly 13,000 people had died from Covid-related illnesses between January 13 and 19, adding to a previous announcement that around 60,000 people had succumbed to the virus in hospitals in just over a month.

But recent local government announcements and media reports have indicated that the wave may have started to recede since peaking in late December and early January when hospitals and crematoriums were packed.

There were 896 deaths attributable to the virus in hospitals on Monday, a decline of 79 percent from January 4, China's Center for Disease Control and Prevention (CDC) said in a statement on Wednesday. — AFP

January 26, 2023 - 12:04pm

The number of daily COVID-19 deaths in China has fallen by nearly 80% since the start of the month, authorities have said, in a sign that the country's unprecedented infection surge may have started to abate.

A wave of virus cases has washed over the world's most populous nation since Beijing abruptly ended its zero-COVID policy last month.

Beijing's figures are believed to only represent a fraction of the true toll, given China's narrow definition of a COVID death and official estimates that swathes of the population have been infected.

The CDC last week said nearly 13,000 people had died from Covid-related illnesses between January 13 and 19, adding to a previous announcement that around 60,000 people had succumbed to the virus in hospitals in just over a month.

But recent local government announcements and media reports have indicated that the wave may have started to recede since peaking in late December and early January when hospitals and crematoriums were packed.

There were 896 deaths attributable to the virus in hospitals on Monday, a decline of 79 percent from January 4, China's Center for Disease Control and Prevention (CDC) said in a statement on Wednesday. — AFP

January 22, 2023 - 4:14pm

China reported nearly 13,000 Covid-related deaths in hospitals between January 13 and 19, after a top health official said the vast majority of the population has already been infected by the virus.

China a week earlier said nearly 60,000 people had died with Covid in hospitals as of January 12, but there has been widespread scepticism over official data since Beijing abruptly axed anti-virus controls last month.

China's Center for Disease Control and Prevention (CDC) said in a statement on Saturday that 681 hospitalised patients had died of respiratory failure caused by coronavirus infection, and 11,977 had died of other diseases combined with an infection over the period. 

The figures do not include those who died from the virus at home.-- AFP

January 20, 2023 - 11:43am

South Korea will drop rules that require people to wear masks in most indoor spaces, authorities say, ending one of the country's last major pandemic restrictions as COVID-19 cases dwindle.

From January 30, it will no longer be mandatory to wear facemasks in most indoor spaces, except on public transport and in medical facilities.

The mask mandate has been in place since October 2020, and is one of South Korea's last remaining pandemic-era restrictions, with other rules from business curfews to social distancing long dropped. — AFP

January 19, 2023 - 10:29am

Xi Jinping says he is "concerned" about the virus situation in the Chinese countryside, state media reported, as millions of people head to rural hometowns ahead of upcoming Lunar New Year celebrations.

The Chinese leader also defended his zero-Covid policy -- lifted last month after crippling the economy and sparking nationwide protests -- saying it had been "the right choice".

In a series of calls Wednesday ahead of the holiday, the Chinese leader told local officials he worried about the situation in the country's rural hinterlands.

"Xi said he was primarily concerned about rural areas and rural residents after the country adjusted its Covid-19 response measures," state news agency Xinhua reports.

He "stressed efforts to improve medical care for those most vulnerable to the virus in rural areas," Xinhua says.

"Epidemic prevention and control has entered a new stage, and we are still in a period that requires great efforts," Xi was reported as saying, stressing the need to "address the shortcomings in epidemic prevention and control in rural areas". — AFP

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