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Global quest underway to speed COVID-19 vaccine trials

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Scientists are working on a benchmark for COVID-19 vaccine efficacy that would allow drugmakers to conduct smaller, speedier human trials to get them to market and address a huge global vaccine shortage.

Researchers are trying to determine just what level of COVID-19 antibodies a vaccine must produce to provide protection against the illness. Regulators already use such benchmarks – known as correlates of protection – to evaluate flu vaccines without requiring large, lengthy clinical trials.

“You could use it to predict efficacy from a vaccine, which will be more important as we are less able to conduct placebo-controlled trials,” said Stanley Plotkin, inventor of the Rubella vaccine and an expert on correlates of protection.

“The information is flowing in,” he said. “By the end of this year, I think there will be enough data to convince everyone.”An established benchmark for COVID-19 would allow drugmakers to conduct vaccine trials in just a few thousand people, about one-tenth the size of the studies conducted to gain authorization for currently widely-used coronavirus shots, researchers and drugmakers told Reuters. Those studies, involving tens of thousands of volunteers, compared the rate of COVID-19 infections in people who received the shot with the rate in participants who got a placebo. Such randomized, controlled trials may no longer be considered ethical in some countries, as researchers cannot give a dummy shot to people where an effective vaccine is widely available. In addition, many of the new shots are being developed by small companies that may not be able to conduct very large trials without government funding or a partner with deep pockets. With an established correlate, drugmakers could test blood samples from a smaller number of trial participants who receive an experimental vaccine to see whether they produced that benchmark level of protective antibodies.

Such a benchmark is “urgently needed” to help overcome challenges faced by vaccine developers and boost availability of shots, Dr. Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai in New York wrote this month in the journal Nature. Researchers at Oxford University late last month proposed a potential correlate of protection based on antibodies found in people who had received the AstraZeneca vaccine. The work awaits peer reviewed by other scientists. Results from a U.S.-backed study of Moderna’s vaccine are expected to be published in a medical journal later this summer. “We’re writing the paper right now,” said Dr. Peter Gilbert, a biostatistician from the Fred Hutchinson Cancer Research Center. Some vaccine experts question whether antibody levels will be a strong enough indicator of protection. Other components of the immune system, such as T-cells and B-cells, are thought to provide important defenses against COVID-19, but are more difficult to measure.

That has been the contention of some top vaccine experts at Pfizer, maker along with BioNTech of one of the most effective COVID-19 vaccines, produced in the largest quantities globally. It is also possible that each different type of coronavirus vaccine will require its own correlate, some experts said. Drugmakers working on a new type of vaccine likely would not be able to rely on the correlates based on Moderna’s messenger RNA shot, they say.

BRIDGING THE GAP Meanwhile, vaccine developers are trying to devise acceptable substitutes to huge, placebo-controlled trials. Some aim to show their shot provokes antibody responses at least as good as those seen with currently authorized shots. European and UK health regulators are working with companies to set standards for these so-called “immunobridging” studies. The U.S. Food and Drug Administration declined to say whether it would accept such trials for next-generation vaccines.

“It doesn’t have to be an established correlate of protection, but we have to … arrive at the right pre-specified criteria, because we cannot risk that a second-generation vaccine … is of low or modest vaccine efficacy,” FDA vaccine official Dr. Marion Gruber told fellow regulators at a World Health Organization Meeting in May. “That would undermine confidence in the vaccine enterprise.”

Italy’s ReiThera Srl is developing a vaccine using technology similar to AstraZeneca’s and will try to demonstrate that its shot is at least as effective.

The company has an agreement in principle on trial design with European and British regulators, ReiThera’s senior director Stefano Colloca told Reuters. Massive clinical trials are “no longer ethical and feasible in most countries worldwide,” he said. French biotech Valneva and Taiwan’s Medigen Vaccine Biologics Corp plan to test their vaccines against the AstraZeneca shot, even though both use a different technology. Valneva’s trial design was approved by UK regulators. Medigen has a green light from Taiwan.

Sanofi, with partner GlaxoSmithKline, and Canada’s Medicago are still opting for placebo-controlled trials involving thousands of participants, including in countries with high infection rates and fewer authorized vaccines available.

NEED FOR BOOSTERS? The hunt for a correlate is underway from the UK to the United States and Australia. Scientists are comparing antibody levels in vaccinated people who became infected with COVID-19 to those who did not, to find a threshold of protection that made the difference. Oxford University researchers said work is needed to address correlates for emerging virus variants, such as the highly transmissible Delta that has quickly become dominant globally. Their proposed antibody model is based on trial volunteers who had mainly contracted the earlier Alpha variant, first identified in the UK.

U.S. government-backed scientists are studying infections in people who received the Moderna vaccine. Moderna spokesman Ray Jordan said the company is also working on the analysis and will publish updates when available. The correlate benchmark might also indicate when and whether people need vaccine boosters.

Pfizer has sought authorization for a third booster dose of its vaccine, citing evidence of waning neutralizing antibody levels. But the company has pushed back against the idea that those same antibodies could be used to predict vaccine efficacy.

“No formal timeline is in place to have correlates of protection established,” a Pfizer spokesperson said. “We will continue to work with the scientific community to better understand what immune responses, whether neutralizing antibodies or otherwise, might contribute to protection.”

(Reporting by Julie Steenhuysen in Chicago and Ludwig Burger in Frankfurt; Additional reporting by Emilio Parodi in Milan, Matthias Blamont in Paris, Michael Erman in Maplewood, New Jersey, Allison Martell in Toronto and Ben Blanchard in Taipei; Editing by Michele Gershberg and Bill Berkrot)

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People Recovered From Covid-19 Still Need Vaccine – TheHealthMania

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Photo by Tara Winstead from Pexels

The Covid-19 vaccine is now available in most countries across the world and health experts recommend getting the jab as soon as possible. Amid the rollout of vaccines, some people who contracted the virus and recovered from it wonder if they should get the vaccine or not. Since exposure to the coronavirus leads to the production of antibodies, some people think they have adequate immunity against the virus. However, the health experts recommend otherwise and suggest getting the vaccine like any other person.

Also read- UK Decided Not To Give Covid-19 Vaccine to the Children

According to the Lake County health officer, Dr. Chandana Vavilala, everyone should get the Covid vaccine at the earliest no matter if they developed a coronavirus infection or not. She recommends getting the vaccine as the cases of Covid-19 surge again in this region as the summer season comes to an end. Dr. Vavilala also mentioned that we can prevent the next wave of the pandemic by getting vaccinated as early as possible. It can help save from contracting the fatal virus and protect the community as well.

The data from the Indiana Department of Health shows nearly 48% of the residents of Lake County fully vaccinated. The data shows that these people received both shots of the Moderna and Pfizer vaccine. Also, this data includes those who got the single-shot vaccine, Johnson and Johnson.

Some health experts including Dr. Vavilala believe that some of the people who did not receive any vaccine are those who previously contracted the coronavirus infection. These individuals may believe that they have lifetime protection against the virus after developing the infection. However, it is not the case and they need the vaccine shot just like other residents of their community.

Dr. Vavilala also mentioned that the three approved Covid-19 vaccines in Lake County are more effective as compared to the natural route of infection. These vaccines provide a stronger and more long-lasting immune response to keep severe infection at bay. Moreover, these vaccines are also effective against the different variants of the coronavirus.

According to Dr. Vavilala, most people hospitalizing after contracting coronavirus are those who did not receive any vaccine. This shows that the coronavirus vaccine works despite the evolution of the virus. Also, the number of variants released into the communities. She also mentioned that new variants spread faster and cause more severe infections as compared to the original strain. Hence, it is strongly recommended to get the coronavirus vaccine to prevent the infection.

Also read- BreakThrough Covid Cases: Can the Vaccinated People Prevent Infection?

Dr. Vavilala also mentioned that the increased number of vaccinated people will help the communities develop an overall immunity against the virus. Therefore, it can help those who could not get the shot because of their health condition or age. She said that the people who previously got the coronavirus infection should go ahead and receive their vaccine dose. It does not matter if they got the infection in the past as it does not provide adequate immunity.

The increased immunization rate can help prevent the rapid spread of new coronavirus variants. Also, it can provide help for those who are unable to get their vaccine due to one reason or another.

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Ontario reports 170 COVID-19 cases, 3 deaths; 124K more vaccines administered – Global News

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Ontario reported 170 COVID-19 cases on Saturday, bringing the total number of cases in the province to 549,156.

“Locally, there are 44 new cases in Toronto, 26 in Peel Region, 17 in Hamilton, 15 in the Region of Waterloo and 13 in Grey Bruce,” Health Minister Christine Elliott said.

For comparison, last Saturday 176 cases were reported.

Read more:
‘Vaccine certificates’ may speed up reopening, incentivize vaccination: Ontario science table

Three new deaths were also announced on July 24, bringing the provincial virus-related death toll to 9,311.

A total of 538,421 coronavirus cases are considered resolved, which is up by 150 and is 98 per cent of all confirmed cases.

More than 19,100 additional tests were completed. Ontario has now completed a total of 16,451,025 tests and 5,325 remain under investigation.

The province indicated that the positivity rate for the last day was 0.8 per cent, which down slightly from Friday’s report, when it was 0.9 per cent, and up from last Saturday’s report, when it was 0.6 per cent.

Provincial figures showed there are 132 people in intensive care due to COVID-19 (down by four), 86 of whom are on a ventilator (up by two).


Click to play video: 'Science advisory table proposes COVID-19 vaccine certificates for Ontario'



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Science advisory table proposes COVID-19 vaccine certificates for Ontario


Science advisory table proposes COVID-19 vaccine certificates for Ontario

Here is a breakdown of Ontario’s cases by age and gender:

  • 273,725 people are male
  • 271,734 people are female
  • 88,751 people are 19 and under
  • 205,695 people are 20 to 39
  • 156,528 people are 40 to 59
  • 72,892 people are 60 to 79
  • 25,196 people are 80 and over

The province notes that not all cases have a reported age or gender.

The province also notes that the number of cases publicly reported each day may not align with case counts reported by local public health units on a given day. Local public health units report when they were first notified of a case, which can be updated and changed as information becomes available. Data may also be pulled at different times.

As of 8 p.m. Friday, 18,848,661 COVID-19 vaccine doses had been administered in Ontario, marking an increase of 124,261. Of those, 105,628 were second doses.

In Ontario, 80.7 per cent of adults aged 18-plus have received at least one vaccine dose and 67.1 per cent are fully vaccinated.

© 2021 Global News, a division of Corus Entertainment Inc.

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NB businesses ponder how to proceed once pandemic restrictions are removed – CBC.ca

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How fast to return to normal? That’s the question some business owners are asking in the wake of news that New Brunswick will remove its COVID-19 restrictions in less than a week.

More than 16 months have passed since the province implemented restrictions limiting the number of customers inside businesses, and enforcing mandatory masking and physical distancing. 

At the end of the day next Friday, July, 30, those pandemic restrictions will end. 

But when the clock strikes midnight don’t expect those precautions to magically disappear from all businesses.

The province has said businesses can choose to ease out of the restrictions more slowly if they want. 

Dave Traboulsee, the owner of River Valley Footwear in downtown Fredericton, said that’s exactly what he plans to do. 

Dave Traboulsee will start allowing more customers into his store once restrictions are lifted, but doesn’t expect to operate at full capacity right away. (Gary Moore/CBC)

Gauging by what he’s heard from his customers, he’s planning a cautious approach. 

“I don’t think we can fully go back to normal yet — there’s still a lot of anxiety out there with shopping,” he said. 

Until now he’s only been allowing people from two bubbles inside the store at a time.  

He plans to increase that capacity slightly once the restrictions are removed, but said he hopes to talk to other business owners in the area to get a sense about whether masks should still be worn. 

“It’s quite a big move to go from certain restrictions and keeping masks on to a free-for-all — and I don’t think we can go to a free-for-all,” he said.

Staff at Café Cest la Vie in Moncton hope the move to the green phase will bring more people back to work downtown. (Submitted/Facebook)

In Moncton, those who work at Café Cest la Vie are hoping the move will bring more people back to work downtown again, and in turn, bring more people back into their shop.

Rebecca McCabe is a barista at the cafe and said masks will no longer be required, and they intend to get back to doing events again, like poetry readings and live music. 

“It also means it’s an opportunity for us to have more people in the cafe so we can open up our capacity again.”

McCabe said they are still trying to figure out if there will be any restrictions in place at the cafe, but generally expects it to be a return to normal.

“Everyone seems pretty excited honestly — I think it will be nothing but help,” she said.

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