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. Required fields are marked *

Pandemic

US coronavirus: Mask mandates are back on the table as Covid-19 surges nationwide

Published

on

Now that Covid-19 cases and hospital stays across the country are on the rise, safety precautions such as mask requirements are being re-considered. Former US surgeon general Dr. Jerome Adams said Friday that the CDC needs to clear its messages in order to get the Americans back on track with curbing the rising tide of infections. The CDC’s decision “trusted the American people to really do the right thing, but unfortunately people chose to go out and take off their masks, whether they were vaccinated or not,” CNN’s Adams Anderson Cooper said.

“We have to trust our health officials to give the best advice possible at this point, and the CDC gave the best advice at that time,” he added. “But guess what? That was before the delta climb. The delta variant changes things.”

The Delta variant, believed to be more transmissible and dangerous, accounted for an estimated 83% of coronavirus cases in the US this week, according to the CDC, a significant increase from the negligible numbers in early May-daily average newer Covid-19 cases matched or exceeded the week before, according to the latest figures from Johns Hopkins University on Friday. Health experts have repeatedly pointed to preventive vaccination as the best way to forestall surges due to its proven effectiveness, but CDC data from Friday showed vaccination rates continued to slow. The daily average of people who get fully vaccinated is the lowest since late January, when the US was just starting to ramp up its vaccination campaign.

Thirty states still need to fully vaccinate at least half of their residents, with Alabama and Mississippi having less than 35% fully vaccinated, according to the CDC.

In Alabama, Governor Kay Ivey called on “the unvaccinated people” Thursday over the surge in Covid-19 cases. “People should have common sense. But it’s time to blame the unvaccinated people, not the normal people. It’s the unvaccinated people who are failing us, ”she told reporters in Birmingham.

As the numbers lag, officials say more countermeasures against Covid-19 are likely needed.

The CDC’s guidelines on how to wear masks haven’t changed, but CDC director Rochelle Walensky said the places may want to make their own phone call on Thursday.

“Communities and individuals need to make the right decisions for them based on what is going on in their local area,” she said. “So if you are in a high case, low vaccination area, where Delta cases are increasing, you should definitely wear a mask if you are not vaccinated.”

People shop at a grocery store enforcing the wearing of masks in Los Angeles on July 23, 2021.

Mask requirements encounter resistance

In view of the increasing number of infections, some state and local politicians are now recommending that vaccinated people also wear masks indoors.

Health officials in Seattle and King Counties, Washington found Friday that the prevalence of the Delta variant in the US was 1.4% on May 13 when the CDC lifted mask requirements for vaccinated individuals. Right now, Delta accounts for 56% of known infections in King County, and the number is expected to increase.

“I know this is frustrating and perhaps disappointing for many, certainly for me,” said Dr. Jeffrey Duchin, Seattle and King County’s Public Health Commissioner, on Friday.

Georgia family mourns

“And I recognized that the change in communications at the national level was a real problem, but we in public health have an obligation to be realistic about the changing situation and provide the best possible guidance.”

Officials in St. Louis, Missouri, went a step further by introducing a mandate for indoor masks in public facilities starting Monday and joining Los Angeles County as one of the first areas in the country to reintroduce such measures.

Missouri has one of the highest rates of average daily new cases per capita, according to data from Johns Hopkins University.

“The new rule requires everyone over the age of five, including those who have been vaccinated, to wear a mask. The wearing of masks outdoors, especially in group situations, is strongly recommended,” said a statement from the mayor’s office. Exceptions apply to those who sit and eat in bars and restaurants.

“We have lost more than 500 St. Louisans to Covid-19, and if our region doesn’t work together to protect one another, we could see spikes that overwhelm our hospital and public health systems,” said Dr. Fredrick Echols. Acting Director of Health for the City of St. Louis.

As Covid cases increase, some conservatives are making a surprise course correction on the vaccine ahead of the 2022 midterm elections

However, Missouri Attorney General Eric Schmitt said Friday that he would go to court to stop the request.

“The citizens of St. Louis and St. Louis Counties are not subjects – they are free people. As their attorney general, I will file a lawsuit on Monday to stop this madness, ”Schmitt said in a statement on Twitter.

Officials elsewhere are also defending themselves against proposed internal mandates. Arizona Governor Doug Ducey encouraged people in his state to get the vaccine and thanked “the miracle of modern science,” but reiterated that he would not allow vaccination or mask mandates.

In Texas, Austin Mayor Steve Adler says that if he “could order all children and teachers to mask themselves without going to court,” he would do it “in the blink of an eye,” as Austin Public Health’s daily average counts Covid-19 hospital admissions reported has more than tripled since July 4th.

However, Texas Governor Greg Abbott issued an executive order in May banning state government agencies such as counties from wearing masks.

Security restrictions will be introduced for the new school year institute

With the new school year approaching – and access to vaccinations only for those over the age of 12 – some districts are preparing to return to masked classes.

Washington DC Public Schools, Boston Public Schools, and the Madison Metropolitan School District in Wisconsin are among those that recently announced that students and staff are required to wear masks in school buildings.

At least nine of the top 20 US school districts make masks optional for students

Still other places, such as Texas and Iowa, have prevented officials from exercising local control by requiring masks.

Last week California announced strict statewide measures on masks in classrooms, but changed its stance hours later, allowing local decisions.

“California school policies are being clarified regarding masking enforcement, recognizing the expertise of local schools in protecting students and educators while ensuring schools are fully reopened for face-to-face teaching,” the update said , which was released via a tweet from the California Department of Health.

CNN’s Lauren Mascarenhas, Raja Razek, Chris Boyette, Roxanne Garcia, Deidre McPhillips, Carma Hassan, Cheri Mossburg and Joe Sutton contributed to this report.

Continue Reading

Pandemic

Oregon firefighters face return of hazardous conditions, COVID-19 outbreak

Published

on

The bootleg fire is lit in the distance, near Beatty, Oregon, the United States, July 13, 2021. Image dated July 13, 2021. REUTERS / Mathieu Lewis-Rolland / File Photo

July 23 (Reuters) – Strike teams moving forward against a huge forest fire in Oregon faced a resurgence of dry, windy weather on Friday while a COVID-19 outbreak among firefighters created a new complication in the three-week fight old fire.

Hundreds of kilometers to the northeast, the US Bureau of Land Management reported that five firefighters were injured in Montana on Thursday when a sudden shift in the wind blew flames over their position on the verge of a much smaller conflagration there.

Both developments came when the National Weather Service issued warnings for south-central Oregon, most of Montana, and part of eastern Idaho. More than 80 major forest fires are raging in these three states and ten others in the west, according to the National Interagency Fire Center.

The Oregon recommendation came as the relatively favorable weather that had helped firefighters gain ground against the bootleg fire in recent days ended. The fire has been burning in and around the Fremont-Winema National Forest since early July.

The region is facing a weekend with a newly increased fire risk from lower humidity and strong, gusty winds that “fan the flames and spread embers,” Sarah Rogowski, a meteorologist with the National Weather Service in Salt Lake City, told Reuters.

By Friday, the bootleg had blackened more than 162,000 acres of drought-dried brush and wood and destroyed at least 67 homes near the California border. At its peak, an estimated 2,000 people were displaced by evacuations.

U.S. Forest Service investigators determined the fire was started by a lightning strike, but smoldered for about five days before it was discovered and reported on July 6

Recent reports have shown that ground crews, assisted by water-dropping helicopters and aircraft tankers, managed to cut containment lines from around 40% of the fire, up from just 7% a week ago.

Although the spread of the fire has slowed in recent days, the fire is still the third largest fire in Oregon since 1900 and by far the most massive of the numerous wildfires that broke out in the western United States this summer.

Operations leaders faced another challenge – a coronavirus outbreak that has forced them to quarantine at least nine firefighters who tested positive after showing mild symptoms of COVID-19, officials said.

A full recovery was expected of all.

“You have to perform on a daily basis and that leads to potential exposure,” said Stefan Myers, spokesman for the incident, adding that COVID safety measures, including social distancing in all four fire camps, appeared to be working for the most part.

The number that was put on the side was a small fraction of the over 2,300 employees assigned to the bootleg fire. However, the outbreak has prompted an investigation by the Oregon Health Authority and will lead to heightened precautionary measures.

In east-central Montana, another lightning fire that scorched less than 400 acres – a tiny fraction of the bootleg’s footprint – injured five U.S. government firefighters as they worked to build a line of defense around its perimeter.

The Bureau of Land Management did not provide any information about their condition, but said the five would be “further medicated to determine the extent of their injuries” after they were evacuated.

Three of the firefighters were part of a US Fish and Wildlife Service crew from North Dakota. The other two were Forest Service firefighters in New Mexico.

“This incident happened so quickly that the firefighters didn’t have much time to react,” Fish and Wildlife spokeswoman Kari Cobb told Reuters.

Reporting by Barbara Goldberg in New York and Steve Gorman in Los Angeles; Additional coverage by Rich McKay in Atlanta and Keith Coffman in Denver Edited by Mark Potter and Sonya Hepinstall

Our Standards: The Thomson Reuters Trust Principles.

Continue Reading

Pandemic

Gov. Edwards, LDH Update COVID-19 Guidance, Recommending All Louisianans Now Wear Masks Indoors for the Duration of Louisiana’s Fourth COVID Surge

Published

on

As COVID-19 cases and hospital admissions continue to surge in Louisiana, and after Louisiana was classified as a “State of Concern” by the White House due to its rapid rise in cases and inadequate vaccination rates, Governor John Bel Edwards and the Louisiana Department of Health released updated guidance today which recommends that all individuals, both vaccinated and unvaccinated, wear masks indoors if a distance of at least two meters is physically impossible during the fourth surge in COVID-19.

Updated LDH guidelines on masking, testing for vaccinated individuals, and workplace accommodation are part of Louisiana’s strategy to end the fourth surge in COVID and increase vaccination rates. Additional measures can be announced later if the situation worsens.

“The White House has informed Louisiana that we are a worrying condition as we are at the forefront of the COVID-19 surge due to the rapid spread of the Delta variant among the unvaccinated in our state. In fact, Louisiana leads the nation in case growth with 47 cases per capita. This should come as no surprise to anyone who has watched our case numbers and hospitalizations continue to grow, and it requires additional guidance on how all people should stay safe now in Louisiana, including how to wear masks indoors when they are unable to socialize Maintaining distancing, testing for suspected exposure even if vaccinated, and working from home when possible to limit group exposure, ”said Governor John Bel Edward. “Right now, Louisiana has the best tool it ever had to combat this surge: the COVID-19 vaccines. Fortunately, our weekly vaccination rate has increased, which in my opinion means that everyone knows how urgent the situation is. We need more people in our state to go up their sleeves and take the COVID-19 vaccine. Increased vaccinations combined with more masking, testing and distance can get us out of the fourth climb, but only if people act quickly. “

“We are on a very dangerous climb right now,” said Dr. Joseph Kanter, State Health Officer. “To ensure their own safety, the people of Louisiana should take precautions immediately. Masking and testing will limit death and suffering until we get through it. “

UPDATED MANUAL FROM LDH

With COVID-19 cases and hospitalizations soaring across Louisiana, and as the country learns more about the transmission dynamics of delta breakthrough cases, the Louisiana Department of Health is today recommending additional safeguards for all residents, regardless of vaccination status. This updated guide includes:

  • All people – vaccinated and unvaccinated – should wear face masks indoors when a physical distance of two meters cannot be maintained.
  • All companies should review their operations to accommodate employees to reduce unnecessary contact in order to avoid the spread of COVID in the workplace.
  • All people should take a COVID test immediately after having known or suspected exposure to COVID-19.
    • If positive, they should be isolated immediately.
    • If the result is negative, the test should be repeated between five and seven days after exposure.
    • If at any point they develop symptoms of COVID-19, they should test and isolate immediately until results are in.

These guidelines will remain in place at least until Louisiana has safely weathered its fourth COVID-19 surge, with additional guidance and containment measures being put in place if necessary to slow the spread of the more contagious and virulent Delta variant and increase hospital capacity to obtain .

The following guidelines from LDH and CDC have not yet changed:

  • Currently, the CDC advises that fully vaccinated individuals do not need to be quarantined after exposure to COVID-19, and LDH is not yet changing these guidelines.
  • Anyone with symptoms of COVID-19, even those who are fully vaccinated or have no known exposure, should get tested.
  • Anyone who tests positive should isolate themselves immediately. Isolation (for those who test positive for COVID-19) usually consists of:
    • If symptoms occur, symptoms will improve for at least 10 days since symptoms first appeared and for at least 24 hours without a fever without antipyretic medication
    • If asymptomatic, but with a positive test, 10 days after taking the test sample

Local leaders can take mitigation measures that are broader than current state guidelines if they feel it is best for their communities. In addition, local school authorities are currently setting masking and mitigation guidelines for their schools.

UPDATES FOR EMPLOYEES IN THE STATE GOVERNMENT OF LOUISIANA

According to the governor’s proclamation, heads of state government agencies are empowered to issue masking procedures and orders indoors when social distancing is not an option. Starting Monday, June 26, the executive bodies in the governor’s cabinet will prescribe masks for staff and visitors in interiors of state buildings when distancing is not possible.

In addition, appointing authorities are instructed to review their current operations to accommodate employees in a way that reduces unnecessary contact in order to avoid the spread of COVID in the workplace.

  • click Here to view the dates of today’s presentation.
  • click Here to read the governor’s updated public health emergency order.

REVIEW FOR COVID-19 SYMPTOMS

A variety of symptoms have been reported in people with COVID-19 – from mild symptoms to severe illness. Symptoms can appear two to 14 days after exposure to the virus. Anyone can have mild to severe symptoms. People with these symptoms can have COVID-19:

  • Fever or chills
  • to cough
  • Shortness of breath or difficulty breathing
  • Fatigue
  • Muscle or body pain
  • a headache
  • New loss of taste or smell
  • Sore throat
  • Constipation or runny nose
  • Nausea or vomiting
  • diarrhea

This list does not include all possible symptoms and the CDC continues to update this list as it learns more about COVID-19. Older adults and people with serious underlying conditions such as heart or lung disease or diabetes may be at a higher risk of developing more serious complications from COVID-19.

Continue Reading
Advertisement

Trending