Connect with us

Pandemic

Novavax Offers U.S. a Fourth Strong Covid-19 Vaccine

Published

on

Novavax, a small American company that has benefited from generous support from the U.S. government, announced the results of a clinical trial of its Covid-19 vaccine in the United States and Mexico on Monday, finding that its two-shot vaccine had one offers effective protection against the coronavirus.

In the 29,960-person study, the vaccine showed an overall effectiveness of 90.4 percent, on par with the vaccines from Pfizer-BioNTech and Moderna and higher than the single-use vaccine from Johnson & Johnson. The Novavax vaccine showed 100 percent effectiveness in preventing moderate or severe illness.

Despite these impressive results, the future of the vaccine in the United States remains uncertain and may be needed more in other countries. Novavax says it may not seek emergency clearance from the Food and Drug Administration until the end of September. And with an ample supply of three other approved vaccines, the agency may instruct Novavax to apply for a full license instead – a process that could take several additional months.

The company’s CEO, Stanley Erck, admitted in an interview that Novavax would likely get its first approval elsewhere. The company is also applying in the UK, the European Union, India and South Korea.

“I think the good news is that the data is so compelling that it gives anyone an incentive to pay attention to our records,” said Mr. Erck.

If Novavax gets the green light from the US government, it could be too late to contribute to the country’s first wave of vaccinations. However, many vaccine experts believe that as immunity declines and variants emerge, the country will eventually need booster vaccinations. And the protein-based technology used in the Novavax vaccine can do a particularly good job of enhancing protection, even if people have previously been vaccinated with a different formulation.

“They really can be the right ones for boosters,” said Dr. Luciana Borio, who was the acting Chief Scientist of the FDA from 2015 to 2017.

Last year, the Trump administration’s Operation Warp Speed ​​program awarded Novavax a $ 1.6 billion contract for 100 million future cans. The company gained this tremendous support despite not having launched a vaccine in over three decades.

In January, Novavax announced that its 15,000-person study in the UK found the vaccine to be 96 percent effective against the original coronavirus. Against Alpha, a virus variant identified for the first time in Great Britain, the effectiveness fell slightly to 86 percent. In South Africa, where Novavax conducted a smaller study of 2,900 people and dominated the beta variant, the company found an effectiveness of only 49 percent.

However, the study in South Africa was made difficult by the fact that some of the volunteers had HIV, which is known to interfere with vaccination. In addition, the study was so small that it was difficult to gauge how much protection the vaccine would offer HIV-negative volunteers.

With the support of Operation Warp Speed, Novavax made plans for an even larger late-stage trial in the United States and Mexico. But manufacturing difficulties delayed the launch until December.

By then, the United States had approved the Pfizer-BioNTech and Moderna vaccines. In February, while the Novavax trial was still ongoing, the Johnson & Johnson’s government approved.

While Novavax waited for the study results, Novavax has teamed up with other companies to begin manufacturing massive quantities of its vaccine. In India it has partnered with the Serum Institute and in South Korea with SK Biosciences. Novavax has reached an agreement with Gavi, the Vaccine Alliance, to supply 1.1 billion doses to middle and low income countries.

The company’s scaling difficulties persisted, however, and it took more time to develop specific tests to validate the quality of its product.

The new results were based on 77 test subjects who contracted Covid-19. The volunteers who received the placebo injections got sick far more often than the vaccinated, a statistical difference that led to an effectiveness of 90.4 percent.

“That’s a strong result,” said Natalie Dean, biostatistician at the University of Florida. “It takes you to this high level.”

The vaccine showed the same effectiveness in a group of high-risk volunteers – people who were over 65 years old, had medical risk factors, or had jobs that exposed them to the virus.

Novavax sequenced the genomes of 54 of the 77 virus samples and found that half were alpha, the variant that became predominant in the United States that spring.

The side effects of the vaccine were relatively mild. Some volunteers reported fatigue, headaches, and other minor symptoms. “This vaccine seems to make the arms lighter,” said John Moore, a virologist at Weill Cornell Medicine who volunteered in the Novavax study.

Novavax will file for approval in the US after it completes the development of a quality control test, the managing director said. “You definitely have to test them from Sunday to show that you get the same answer under all conditions,” said Erck. “And that takes time.”

Mr. Erck said the company plans to produce 100 million cans per month by the end of the third quarter and 150 million cans per month by the end of the fourth quarter.

Every week the United States is building up a wider range of approved vaccines from other companies, raising the question of whether the country needs to issue more emergency permits or EUAs.

“The law says that once you have adequate doses, no additional EUAs are required,” said Dr. Borio.

A sign that the FDA is changing its approach to Covid-19 vaccines came last week. An American company called Ocugen had applied for an emergency permit for Covaxin, a Covid-19 vaccine that is now used in India. However, on Thursday the company announced that the FDA had recommended that the standard route to full approval be followed instead, the so-called biologics license application, which takes many additional months.

However, since Novavax has been consulting with the FDA about its studies since last year, Mr. Erck said the company may be able to continue its plans to apply for an emergency clearance.

“So far you have indicated that if you are in favor of an EEA, you can proceed for an EEA,” said Mr Erck. “Anyone could tell you that could change, but I don’t know how to predict it.”

Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the FDA’s Vaccine Advisory Panel, said Novavax’s potent vaccine is most welcome. “The more the better,” he said. “I think there is room for a lot more vaccines because we will be dealing with this virus for years, if not decades.”

Novavax is preparing for this future by researching how its vaccine could work as a booster. A new version of the vaccine contains the proteins of the beta variant first identified in South Africa.

Researchers gave baboons beta boosters that had been vaccinated a year ago in experiments with the original version of the Novavax vaccine. The researchers found that the baboon’s immunity to Covid-19 skyrocketed after this booster, protecting them from beta, alpha, and the original version of the coronavirus.

“When you boost, you see a very high recall response,” said Matthew Frieman, a virologist at the University of Maryland School of Medicine and co-author of the new study. The study has not yet been published in a scientific journal.

Dr. Frieman said the new study offers encouraging evidence that Novavax vaccines might work well as boosters. It also suggested that first-time vaccines people might do well to get a mix of the original and beta versions to expand their protection against new variants, he said.

“Novavax can be used as a booster in the US, but it will certainly be the first vaccine many people around the world will see,” he said.

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published.

Pandemic

New report shows quality of nursing home care spiked during COVID-19

Published

on

TOPEKA, Kan. (WIBW) – A new report shows the quality of care afforded to residents of long-term care facilities during the COVID-19 pandemic spiked significantly.

The American Health Care Association and National Center for Assisted Living says it released a new report on Thursday, March 26, which details data on the quality of care in nursing homes during the COVID-19 pandemic.

AHCA/NCAL said the data highlights the commitment of dedicated caregivers to raising the standard of care for the benefit of residents during an unprecedented global public health crisis. The report follows data the organization issued which highlights improvements over the last decade.

The Association said the report found long-term residents in nursing homes were hospitalized 15% less during the pandemic than they were before while 8% of short-term patients saw functional improvement during the same time period.

AHCA/NCAL also aid the report found 72% of more than 110,000 infection control focused inspections of nursing homes conducted during the pandemic were deficiency-free.

The organization said the report acknowledges the devastating effects of the pandemic had on nursing home residents, however, the tragic loss of life was due to the nature of the virus, not because of inadequate care from caregivers.

Thanks to life-saving vaccines and treatments, as well as enhanced infection control, AHCA/NCAL said nursing home residents are much safer from the virus. Specifically, it said nearly 60% of nursing home resident deaths due to the virus happened during the first 7 months of the pandemic – before vaccines were available.

The Association also said COVID uniquely targets elderly patients and those with underlying health conditions, with the risk of death for those 85 and older being 340 times higher than for those ages 18 to 29.

The report also found independent research from various academic institutions overwhelmingly found a high spread of the virus in the community is correlated with outbreaks in nursing homes. At the height of the Omicron surge in mid-January, it said nursing home residents were more likely to die of complications from the virus compared to the height of the winter surge in 2020 – before the availability of vaccines.

Lastly, the report found over 730,000 nursing home residents have recovered from COVID-19.

“Our heroic long-term caregivers never wavered from our commitment to our residents during the COVID-19 pandemic,” said Mark Parkinson, president and CEO of AHCA/NCAL. “Nursing homes should be recognized for their efforts during this once-in-a-lifetime global crisis, and as we continue to focus on improving the quality of life for our residents, lawmakers and health policy officials must also work with us to implement lasting change by providing resources necessary to further enhance care.”

AHCA/NCAL said it also released a report which highlights federal data indicating the quality of care in nursing homes has risen over the past decade before the pandemic. It said the two quality reports underscore the significant strides providers have made and the continued commitment to better the lives of residents – no matter the challenges providers face.

To read the full Nursing Home Quality Improvement During COVID report, click HERE.

Copyright 2022 WIBW. All rights reserved.

Continue Reading

Pandemic

Select Kroger pharmacies join national “Test to Treat” COVID-19 Initiative

Published

on

CARMEL, Ind. — A spokesperson for Kroger says 12 locations are now ready to participate in the Biden Administration’s “Test to Treat” initiative.

“Any store that has the “Little Clinic” sign with the pharmacy next door, basically,” said Eric Halvorson, a Kroger spokesperson.

White House officials announced the “Test to Treat” program earlier this month during President Biden’s State of the Union address. Back then, officials had said hundreds of COVID-19 treatment pills would be shipped out to pharmacies nationwide by the end of March.

“This is something that was created by the federal government and medical experts who were saying we needed another option to reduce the spread of COVID,” said Halvorson. “We’re making it available as quickly as we can to as many people as we can.”

Friday, Halvorson said select locations had finally received enough supplies to launch the program in their stores.

Gen Con 2022 to keep mask mandates for now

That means Hoosiers can now go to a participating Kroger location, get a rapid COVID test, and then immediately get a COVID-19 treatment pill if they are eligible and their result comes back positive.

“If they have symptoms, they can come in and find out: Are they sick? Do they need something to reduce the severity? Because that’s ultimately another element of this is to make sure that the people who have the greatest risk of a severe condition get the treatment they need,” said Halvorson.

All 12 participating Kroger locations will carry either the Pfizer or the Merck COVID-19 treatment pill.

“That will be up to what’s delivered to the pharmacy. And everything we’re seeing right now indicates we will have plenty of supply. No reason to indicate that we would have to worry about any of that,” said Halvorson.

Officials with Kroger said only those who are considered high-risk would be eligible to get the treatment.

Indy doctor talks chances of Moderna vaccine for kids getting approved

According to the Centers for Disease Control and Prevention (CDC), conditions and factors that may place someone at high risk for severe COVID include, but are not limited to:

  • Cancer
  • Chronic kidney disease
  • Chronic liver disease
  • Chronic lung disease
  • Cystic fibrosis
  • Dementia or other neurological conditions
  • diabetes
  • Down syndrome
  • Heart conditions
  • HIV
  • Immunocompromised state
  • Mental health conditions
  • obesity
  • pregnant
  • Sick cell disease
  • tuxedo
  • Organ or blood stem cell transplant recipient
  • stroke
  • Substance abuse disorders
  • tuberculosis

“Providing the anti-viral agents through our Kroger pharmacy is another way that we can help reduce the spread of COVID and fight it in a different way to make people healthier and safer from the pandemic,” said Halvorson. “We just want to make sure that people have access to another treatment, another option to protect themselves, their families, and their neighbors.”

Halvorson said he strongly recommends Hoosiers call ahead to check the availability of their store before they arrive. He also urged suspected patients to book an appointment online in advance.

Lastly, if you are unable to make it in for an appointment in person, Halvorson said Kroger is also offering virtual appointments.

“If somebody isn’t able to make it into the clinic, they can go to Kroger Health online and do a telehealth visit. There will be an expert on the other end of the screen who can guide them through doing the test at home and then they would be advised about getting a prescription from there,” said Halvorson.

Close modal

Suggest a correction

Continue Reading

Pandemic

Covid-19 Cases, Treatments and Omicron News: Live Updates

Published

on

Credit…Aly Song/Reuters

The surge of Covid cases across China, driven by the highly transmissible Omicron variant, is straining hospitals and prompting lockdowns of neighborhoods in Shanghai, which until recently had been held up as a crown jewel in the government’s strategy for fighting the pandemic.

Shanghai, China’s largest city, has seen few cases until recently. Now, it is reporting more than 1,500 a day, and many residents are expressing anguish and dismay about China’s zero-tolerance approach to the virus.

On Friday, anger and grief welled up online after a Shanghai hospital confirmed reports that a nurse who worked there, Zhou Shengni, had died from an asthma attack after finding the doors of its emergency department shut because of Covid restrictions.

“Due to pandemic prevention needs, the emergency department of our hospital’s southern campus had been temporarily closed,” Shanghai East Hospital said on its website. Ms. Zhou’s family rushed her to another hospital, but she died late Wednesday after “attempts to save her failed,” Shanghai East said.

“Just think, this happened in Shanghai, and it was a medical worker treated like this,” read one of many comments about Ms. Zhou’s death on Weibo, a popular Chinese social media platform. “What about regular folks? Not just in Shanghai, but other parts too.”

The outbreak has fanned a rising debate in China over whether the government should rethink its stringent “zero Covid” strategy of eliminating all infections with relentless force, rather than finding a way to cope with higher levels of infection, as most countries have.

But officials across China have given no indications that the government is reworking its strategy. Instead, they insist that any easing of restrictions could exacerbate the surge of infections and further strain the medical system.

“We hope that everyone slows down their life at this time, cutting down on outings and moving around,” Wu Jinglei, the director of the Shanghai Municipal Health Commission, said at a news conference on Thursday. “Pandemic prevention in our city has entered the most critical stage.”

On Friday, Shanghai’s health commission reported that it had identified 1,609 Covid cases the previous day, 1,580 of which were asymptomatic. China has recorded over 29,000 cases so far in March. That represents a significant spike for the country, which has kept cases low since quashing the world’s first outbreak, which began in the city of Wuhan, in 2020.

The current outbreak has strained Shanghai’s medical system as hospitals and isolation hotels are crowded with patients, residents have said on social media. The city government has started issuing a daily list of hospital clinics that have suspended outpatient and elective treatments and surgeries in order to cope with the Covid cases.

Zhang Wenhong, one of Shanghai’s leading infectious disease experts, told residents on Thursday to be patient while the authorities worked to curb the outbreak.

“All of a sudden medical resources are under strain” in Shanghai, Dr. Zhang wrote in a long post on Weibo. “If we don’t counter its speed with our own, we won’t have a chance to beat the Omicron race,” he wrote, adding that the government would need to ramp up its vaccination campaign.

Beneath his post, many commenters insisted that China rethink its approach to the virus.

“Exhausting social resources, degrading the quality of life and existence, dragging down economic development and urban vitality — where’s the sense in this pandemic prevention,” one commenter wrote. “The zero-infection strategy needs thinking over.”

Continue Reading
Advertisement

Trending