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Novavax developing vaccine that targets new COVID-19 variant

Novavax Inc. said on November 26 the company had started working on a version of a COVID-19 vaccine to target the variant detected in South Africa and would have the shot ready for testing and manufacturing in the next few weeks.

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Novavax developing vaccine that targets new COVID-19 variant

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(Reuters) – Novavax Inc (NVAX.O) said on Friday it had started working on a version of its COVID-19 vaccine to target the variant detected in South Africa and would have the shot ready for testing and manufacturing in the next few weeks.

The company’s COVID-19 shot contains an actual version of the virus’ spike protein that cannot cause disease but can trigger the immune system. The vaccine developer said it had started developing a spike protein specifically based on the known genetic sequence of the variant, B.1.1.529.

“The initial work will take a few weeks,” a company spokesperson said. Shares of the company closed up nearly 9% on Friday.

FILE PHOTO: A woman holds a small bottle labeled with a “Coronavirus COVID-19 Vaccine” sticker and a medical syringe in front of displayed Novavax logo in this illustration taken, October 30, 2020. REUTERS/Dado Ruvic

Novavax’s vaccine received its first emergency use approval earlier this month in Indonesia followed by the Philippines.

The company has said it is on track to file for U.S. approval by the end of the year. It has also filed for approvals with the European Medicines Agency as well as in Canada.

Other vaccine developers, including Germany’s BioNTech SE (22UAy.DE) and Johnson & Johnson (JNJ.N), have said they are testing the effectiveness of their shots against the new variant, which is named Omicron by the World Health Organisation. read more

Inovio Pharmaceuticals Inc (INO.O)said it had begun testing its vaccine candidate, INO-4800, to evaluate its effectiveness against the new variant. The company expects the testing to take about two weeks.

Inovio also said it was simultaneously designing a new vaccine candidate that specifically targeted Omicron.

“Best case scenario, INO-4800 … will be completely resilient against omicron, but if that’s not the case then we will have a newly designed vaccine ready to go if need be,” said Kate Broderick, senior vice president of Inovio’s R&D division.

Earlier this month, Inovio resumed a late-stage trial of its vaccine in the United States after 14 months on clinical hold. read more

Reporting by Manojna Maddipatla and Mrinalika Roy in Bengaluru; Editing by Anil D’Silva

Our Standards: The Thomson Reuters Trust Principles.

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/novavax-testing-vaccine-that-targets-new-covid-19-variant-2021-11-26

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About 35% of People Who Received Placebo in Vaccine Trials Report Side Effects and More COVID-19 News

According to a recent study conducted by researchers at Harvard Medical School and Beth Israel Deaconess Medical Center, 76 percent of the adverse side effects (such as fatigue or headache) that people experienced after receiving their first COVID-19…

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About 35% of People Who Received Placebo in Vaccine Trials Report Side Effects and More COVID-19 News

The placebo effect is where a person who received a placebo instead of a drug or vaccine shows clinical signs, positive or negative, associated with the actual treatment. Much has been made about the side effects of the COVID-19 vaccines, but a new study found a startlingly high number of adverse events associated with people who received placebos in clinical trials. For that and more COVID-19 news, continue reading.

COVID-19 Vaccine Side Effects: Real or Placebo Effect?

A recent study out of Harvard Medical School and Beth Israel Deaconess Medical Center evaluated 12 COVID-19 vaccine trials with a total of 45,380 participants. The study found that 76% of the adverse side effects reported, such as fatigue or headache, after the first shot were also reported by participants who received a placebo. Mild side effects were more common in people receiving the vaccine, but a third of those given the placebo reported at least one adverse side effect. The statistics from the study showing that 35% of placebo recipients reported adverse side effects is considered unusually high. Several experts suspect that there’s such a high report of adverse events because of the amount of misinformation found on social media about the dangers of the vaccines and the amount of media coverage.

This is not to say that the adverse side effects felt by people who received the vaccines are all in their heads. People do have side effects to vaccines, but this study reports on an unusually high level of the placebo effect. Nocebo is used to describe a negative outcome associated with the placebo.

Source: BioSpace

“Negative information in the media may increase negative expectations towards the vaccines and may therefore enhance nocebo effects,” said Dr. Julia W. Haas, an investigator in the Program in Placebo Studies at Beth Israel Deaconess and the study’s lead author. “Anxiety and negative expectation can worsen the experience of side effects.”

Four Factors for Long COVID

A study published in Nature Communications identified specific antibodies in the blood of people who developed long COVID. Long COVID is not well understood and has a range of up to 50 different symptoms, and it is difficult to diagnose because there is no one test for it. The study, conducted by Dr. Onur Boyman, a researcher in the Department of Immunology at University Hospital Zurich, compared more than 500 COVID-19 patients and found several key differences in patients who went on to present with long COVID. The most obvious was a significant decrease in two immunoglobulins, IgM and IgG3. The study found that a decrease in these two immunoglobulins, which generally rise to fight infections, combined with other factors, such as middle age and a history of asthma, was 75% effective in predicting long COVID.

75% of COVID-19 ICU Survivors Show Symptoms a Year Later

A study out of the Netherlands found that a year after being released from an intensive care unit (ICU) for severe COVID-19, 75% of patients reported lingering physical symptoms, 26% reported mental symptoms, and up to 16% noted cognitive symptoms. The research was published in JAMA. The research evaluated 246 COVID-19 survivors treated in one of 11 ICUs in the Netherlands. The mental symptoms included anxiety (17.9%), depression (18.3%), PTSD (9.8%). The most common new physical symptoms were weakness (38.9%), stiff joints (26.3%), joint pain (25.5%), muscle weakness (24.8%), muscle pain (21.3%) and shortness of breath (20.8%).

Pennsylvania Averaging Most COVID-19 Deaths Per Day in a Year

In general, COVID-19 deaths are dropping across the country. However, in two states, Pennsylvania and New Jersey, the numbers are increasing. Pennsylvania is averaging 156 COVID-19 deaths per day over the past seven days, which is a 17% uptick compared to two weeks ago. The number of deaths per day in Pennsylvania is below what was hit in January 2021, largely due to the availability of vaccines. New Jersey averages 111 deaths from COVID-19 per day, an increase of 61% over the last two weeks and the highest since May 2020. Similarly, New Jersey cases and hospitalizations are declining.

Omicron Surge: Shattering Cases and Hospitalizations, but Less Severe

According to the CDC, although the current Omicron surge is setting records for positive infections and hospitalizations, it’s less severe than other waves by other metrics. Omicron has resulted in more than 1 million cases per day in the U.S. on several occasions, and reported deaths are presently higher than 15,000 per week. However, the ratio of emergency department visits and hospitalizations to case numbers is lower compared to COVID-19 waves for Delta and during the winter of 2020–21. ICU admissions, length of stay, and in-hospital deaths were all lower with Omicron. They cite vaccinations and booster shots as the likely cause. Although the overall result is that Omicron appears less severe, it’s not completely clear if that’s because the viral variant doesn’t infect the lower lung as easily as other variants, or because so much of the population has either been vaccinated or exposed to the virus already. It is clearly far more infectious than other strains, which is placing a real burden on healthcare systems. The number of emergency department visits is 86% higher than during the Delta surge.

J&J Expects Up to $3.5 Billion in COVID-19 Vaccine Sales This Year

Johnson & Johnson projected annual sales of its COVID-19 vaccine for 2022 to range from $3 billion to $3.5 billion. This was noted during the company’s fourth-quarter 2021 report. In December 2021, the U.S. Centers for Disease Control and Prevention recommended the PfizerBioNTech or Moderna shots over J&J’s due to a rare blood condition observed with the J&J shot. By comparison, Pfizer and BioNTech project their vaccine will bring in $29 billion in 2022, after having raked in almost $36 billion in 2021. Moderna expects approximately $18.5 billion this year, with about $3.5 billion from possible additional purchases. Although final figures for Moderna aren’t in yet, they projected 2021 sales between $15 and $18 billion.

BioSpace source:

https://www.biospace.com/article/about-35-percent-of-people-receiving-placebo-in-vaccine-trials-report-side-effects-and-more-covid-19-news

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COVID-19 cases at highest ever in Americas – regional health agency

New cases of COVID-19 in the Americas in the past week were the highest since the pandemic began and the very contagious Omicron variant has clearly become the predominant strain, the Pan American Health Organization said on January 26.

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COVID-19 cases at highest ever in Americas – regional health agency

BRASILIA, Jan 26 (Reuters) – New cases of COVID-19 in the Americas in the past week have been the highest since the pandemic began in 2020 and the very contagious Omicron variant has clearly become the predominant strain, the Pan American Health Organization said on Wednesday.

There were more than 8 million new cases, 32% higher than the previous week, while fatalities throughout the region also increased by 37%, with 18,000 new deaths caused by COVID-19.

The United States continues to have the highest number of new infections, although cases decreased by nearly 1 million over the last week, the regional health agency said.

Mexico’s southern states have seen new infections triple and Brazil has seen new cases surge 193% over the last seven days, PAHO said in weekly briefing.

Medical workers take care of patients in the emergency room of the Nossa Senhora da Conceicao hospital that is overcrowding because of the coronavirus outbreak, in Porto Alegre, Brazil, March 11, 2021. REUTERS/Diego Vara

Children in the Americas are facing the worst educational crisis ever seen in the region, with millions of children yet to return to classes, according to PAHO, which recommended that countries try to get them safely back to school to protect their social, mental and physical wellbeing.

It urged parents to get their children vaccinated.

Many countries have already authorized and are safely administering COVID vaccines to adolescents, PAHO said.

Last week, the WHO’s expert group on immunization authorized the COVID vaccine developed by Pfizer Inc (PFE.N) for children aged 5 to 12 years, offering a roadmap for countries to roll out vaccines for them, the regional agency said.

Reporting by Anthony Boadle; Editing by David Gregorio

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/world/americas/covid-19-cases-highest-ever-americas-says-regional-health-agency-2022-01-26

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Don’t believe the claim that only 17,371 people have died from COVID in England and Wales

A freedom of information request is only useful if you know how to read the data.

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There is no doubt that the pandemic has led to many deaths; however, in the past week, new claims have emerged that the true number of people who have died from COVID in England and Wales is much lower than previously thought. These claims have been widely shared on social media and even amplified by a senior MP. Can it really be true that new data shows that COVID has killed far fewer people than we previously thought?

To arrive at an answer, we first need to delve into the various ways that COVID deaths are counted in England and Wales. There are two main sources of this data: the first, published by the UK Health Security Agency (UKHSA) and featured prominently on the government’s coronavirus dashboard, is a simple count of all deaths that occur within 28 days of a positive COVID test.

The second, published by the Office for National Statistics (ONS) is based on death certificates that list COVID as a cause of death. Being based on a medical assessment of the circumstances of each individual death, the ONS figures represent the gold standard.

The UKHSA figures will include some deaths that are clearly unrelated to COVID – for example, somebody who has a mild case of COVID and is involved in a car accident three weeks later – and exclude some COVID deaths where someone is in hospital for more than 28 days. The UKHSA data gives us a picture of what is happening now – albeit an imperfect one – while the ONS data takes several weeks to process.

We also need to understand how death certificates work in England and Wales. When somebody passes away, a medical professional completes a death certificate. This includes a field for the “disease or condition directly leading to death” – often called the “underlying cause”. It also includes the option to list one or two diseases or conditions that were not the underlying cause, but which contributed to the death (“contributory causes”).

The data that the ONS publishes shows that, in 2020 and 2021 combined, 157,889 deaths were registered where COVID was mentioned on the death certificate. Of these, 139,839 listed COVID as the underlying cause. In almost 90% of cases where COVID was a factor in somebody’s death, it was considered by medical professionals to be the primary reason they died. So where does the figure of 17,371 COVID deaths come from?

Freedom of information request

This figure originates from a freedom of information request to the Office for National Statistics that asked for the number of deaths where COVID was the only cause of death recorded. This is complicated by the fact that often COVID itself can cause complications, such as severe respiratory difficulties or organ failure, which will then be listed alongside COVID on the death certificate.

To exclude these deaths, the ONS responded by giving the number of deaths where no “pre-existing conditions” were listed on the death certificate. Which comes to 17,371 for the period up to the end of September 2021. But what is a “pre-existing condition”?

Pre-existing conditions and their International Classification of Diseases (ICD) codes

Office for National Statistics

This list is extensive, including high blood pressure, asthma, COPD, diabetes and a wide range of other common conditions. The argument being made by some is that 17,371 is the true number of COVID deaths, because people with these pre-existing conditions, who make up the vast majority of deaths that list COVID on the death certificate, were already sick. But even a cursory glance at the list makes it clear that this will be incorrect for a great many people.

Over a quarter of adults have high blood pressure, 4 million people in England have diabetes and a similar number have asthma. Having one of these conditions is neither a death sentence nor a sign of being in poor health. You almost certainly know several people with one or more of them, or are living with one yourself.

The idea that people with a pre-existing condition are at death’s door is simply untrue. Over half of people aged 50 and over have at least one long-term health condition. But if someone with one of these conditions is unlucky enough to catch COVID and subsequently die, all it takes is for the condition to have some impact for it to end up being listed as a contributory cause on the death certificate.

Let’s take asthma as an example. COVID frequently attacks victims’ lungs, leading them to require ventilation. As a respiratory condition, asthma may well exacerbate these difficulties and will therefore be listed on the death certificate if the person dies. It would be bizarre to claim that the person died of asthma on this basis. Perhaps they would not have died if they didn’t have asthma, but they certainly wouldn’t have died if they hadn’t got COVID.

The vast majority of people who get seriously ill with COVID were living full, independent lives before they were hospitalised. And reasonable estimates suggest that the average number of years of life lost per COVID death is around ten. The idea that people who died from COVID are all extremely ill and would have died soon anyway is not borne out by the facts.

To argue that the deaths from COVID of people with pre-existing conditions don’t count as true COVID deaths is to say that people with pre-existing conditions don’t matter; that their lives are expendable and shouldn’t be considered when assessing the impact of the pandemic. Over 140,000 people with pre-existing conditions have died of COVID in the last two years. We should be mourning this tragic loss of life, not minimising it.

Colin Angus does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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