AstraZeneca’s COVID Antibody Protects Immune-Compromised

“AstraZeneca, a British-Swedish multinational pharmaceutical and biotechnological company based at Cambridge Biomedical Campus in England, is confident that its new version of COVID-19 antibody treatment is capable of protecting immunocompromised patients against all marked virus variants.”

During the first wave of COVID, many companies proposed their own version of COVID vaccines and AstraZeneca is one of them. It is a British-Swedish multinational pharmaceutical and biotechnological company based at Cambridge Biomedical Campus in England. 

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The pharma company has developed a new version of COVID-19 antibody treatment. The company is confident that this new treatment is capable of protecting immunocompromised patients against all marked virus variants.

According to reports, the company plans to make its antibody available by the end of 2023. This is because of pending regulatory approval and the need for more positive data.

Iskra Reic, Executive Vice President, said, “Laboratory studies show the antibody, called AZD3152, neutralizes all known variants of COVID-19 and AstraZeneca has support from regulators to make the treatment available by the end of this year”

Antibody therapies have become a must for people whose immune systems are compromised. This can be due to undergoing immunosuppressive treatments or having underlying health conditions. These people account for approx 2 percent of the global population.

January 2023, the U.S. health regulator revoked the emergency use authorization of the pharma company’s original COVID-19 antibody cocktail, Evusheld. The reason cited for the revocation was the emergence of new dominant variants of the virus.

The U.S. Food and Drug Administration‘s (FDA) decision matched the concerns which were raised by the health regulator of Europe. 

The multinational pharma company developed a new COVID-19 antibody called AZD3152. Last year, the British biotech startup RQ Bio acquired AZD3152 in a deal worth $157 million.

Iskra Reic also said, “Iskra Reic also said, “The British drugmaker will likely make future investments like its current partnerships with RQ Bio. However, the company did not have any deals to announce at present.”

Low Breastfeeding Rates Found in Infants Born to COVID-19 Affected Mothers: Health Study

“The combined global study of Murdoch Children’s Research Institute and The European Society of Paediatric and Neonatal Intensive Care (ESPNIC) found that the transmission of COVID-19 from mothers to babies was uncommon and typically modest when it did occur.”

A global investigation observed that when the pandemic was at its peak, skin-to-skin contact and breastfeeding rates were low as the majority of infants born to mothers with COVID-19 were kept apart after birth.

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The combined global study of Murdoch Children’s Research Institute and The European Society of Paediatric and Neonatal Intensive Care (ESPNIC) found that the transmission of COVID-19 from mothers to babies was uncommon and typically modest when it did occur.

Yet, 25% of babies were nursed, and most mothers and infants were not in contact right after birth. Around 50% of infants didn’t get their mothers’ breast milk.

Professor David Tingay, Murdoch Children’s Research Institute, said, “the largest on global family-centered care during COVID-19, highlighted how ensuring suitable infection control measures had significantly impacted neonatal practice over the past few years.

Almost half of all newborns in the trial were denied early and close contact with their mother, demonstrating how hard it was to balance infection control measures with mother-baby bonding recommendations, especially in the first year of the pandemic,” he said.

Encouragingly, clinicians did gradually adapt to allow more family-centered care as the pandemic progressed, particularly using breastmilk.”

The study was done on 692 babies born to mothers with SARS-CoV-2. It is held in 13 neonatal intensive care units in 10 countries that include the US, France, Italy, and Brazil. The study was published in The Lancet’s e clinical medicine.

The study also found that 54% of infants were contactless and only 7% had physical contact before separation. Breastfeeding rates were low and were 53% and 24% exclusively fed with their mother’s breast milk.

After COVID-19, FLU is the new primary respiratory illness in US

Figures are indicating that in the United States more people are falling seriously ill with the flu than with COVID-19.

 

Figures

According to The Globe and Mail, “Figures collected by the U.S. Centers for Disease Control and Prevention show that the weekly rate of hospitalizations for the flu has reached 5.9 per 100,000 people, a level not seen at this time of year in more than a decade.

For COVID-19, however, the rate has fallen to 4.3 per 100,000, far below the January high of 34.8. The figures for both the flu and COVID-19 are for the week ending Dec. 3, the most recent data available.

The dwindling severity of COVID-19 comes after President Joe Biden said in September that “the pandemic is over.”

Numbers of COVID-19 cases in the U.S. have been on the rise in recent weeks, with nearly 5,000 daily hospital admissions. But for COVID-19 to qualify as a pandemic virus, “the threshold would be that it is still causing hospitals to be completely disrupted,” said Amesh Adalja, an infectious disease specialist at Johns Hopkins Center for Health Security. “And I don’t think COVID-19 has been doing that for some time.”

We have “ceased seeing hospitals being under siege by the virus,” he added.”

 

The case of COVID-19 now

They also said, “The decreasing severity of COVID-19 is a result of broad exposure to the virus and effective ways to treat it. A large percentage of the world’s population has now either been infected by COVID-19 or immunized against it.

In November, the World Health Organization reported a 90-per-cent drop in COVID-19 deaths, compared to nine months before. More than 70 per cent of the world’s population has now been vaccinated in some form.

New variants emerging today “are much easier to handle because of the immunity in the population,” Dr. Adalja said.”

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Covid wave looms in Europe as booster campaign makes slow start

Source: CNN

 

A new Covid-19 wave appears to be brewing in Europe as cooler weather arrives, with public health experts warning that vaccine fatigue and confusion over types of shots available will likely limit booster uptake.

Omicron subvariants BA.4/5 that dominated this summer are still behind the majority of infections, but newer Omicron subvariants are gaining ground. Hundreds of new forms of Omicron are being tracked by scientists, World Health Organization (WHO) officials said this week.

WHO data released late on Wednesday showed that cases in the European Union reached 1.5 million last week, up 8% from the prior week, despite a dramatic fall in testing. Globally, case numbers continue to decline. Hospitalization numbers across many countries in the 27-nation bloc, as well as Britain, have gone up in recent weeks.

 

New Covid Wave

 

A cargo aircraft operated by Cathay Pacific Airways Ltd. flies approaches Hong Kong International Airport in Hong Kong, China, on Tuesday, Aug. 10, 2021. Cathay is scheduled to report half-year results on Aug. 11. Photographer: Paul Yeung/Bloomberg via Getty Images

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In the week ending October 4, Covid-19 hospital admissions with symptoms jumped nearly 32% in Italy, while intensive care admissions rose about 21%, compared to the week before, according to data compiled by independent scientific foundation Gimbe.

Over the same week, Covid hospitalizations in Britain saw a 45% increase versus the week earlier.

Omicron-adapted vaccines have launched in Europe as of September, with two types of shots addressing the BA.1 as well as the BA.4/5 subvariants made available alongside existing first-generation vaccines. In Britain, only the BA.1-tailored shots have been given the green light.

European and British officials have endorsed the latest boosters only for a select groups of people, including the elderly and those with compromised immune systems. Complicating matters further is the “choice” of vaccine as a booster, which will likely add to confusion, public health experts said. But willingness to get yet another shot, which could be a fourth or fifth for some, is wearing thin.

“For those who may be less concerned about their risk, the messaging that it is all over coupled with the lack of any major publicity campaign is likely to reduce uptake,” said Martin McKee, professor of European public health at the London School of Hygiene and Tropical Medicine. “So on balance I fear that uptake will be quite a bit lower.” Meanwhile, British officials last week warned that renewed circulation of flu and a resurgence in Covid-19 could pile pressure on the already stretched National Health Service.

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Fresh rise in Covid-19 cases

Quebec’s government is seeing a new problem now due to the new wave of Covid-19 cases being witnessed now and increasing number of hospitalizations due to the same. The government has made it clear to not make masks compulsory in the Canadian province despite the warnings given by doctors to do so.

The cases of particularly Omicron BA. 4/5 variants are increasing on a global level. This has resulted in rising number of infections and the authorities are struggling with trying to avoid the extension or re-introduction of certain restrictions that were put before. The common masses now feel the appropriate measures being not taken properly by the government that once imposed quite strict measures before.

 

Quebec facing the seventh wave

 

Donald Vinh,a doctor with the McGill University Health Centre in Montreal, advised Quebec to make the wearing of masks compulsory in indoor public places so as to prevent more infections or death rates from increasing. But the government is “afraid of angry voters,” as Vinh stated “They’re not afraid of dead voters.”

Quebec is facing the seventh wave, like other Canadian provinces. According to the data provided by the government, more than 7,000 health care workers are off the job due to the virus. Acute shortage of staffing services is being witnessed by Quebec as of now.

The province announced 1,887 people being hospitalized because of COVID-19 on Friday. This is an increase of 27 as considering the number from the previous day. The Montreal Children’s Hospital said it was “unable to see patients whose condition is non-urgent.”

 

View of experts

 

Dr. Marie-France Raynault, a senior public health adviser, told reporters on Thursday, “I believe in education and not always in mandatory measures.”

 

Epidemiologist Catherine Hankins, co-chair of Canada’s COVID-19 Immunity Task Force, told Reuters this month a mask mandate is not yet needed but would be if this wave worsens.

 

“Everybody’s thinking, ‘Oh, we have the summer off,'” she said. “But … this wave is picking up now.

Pfizer Inc. and BioNTech signed a $3.2 billion deal with the U.S. government

Pfizer Inc. and their partner BioNTech made an announcement on Wednesday that they signed a $3.2 billion deal with the U.S. government for 105 million doses of their COVID-19 vaccine. They are also set to deliver the Vaccines by this summer’s last only.

 

What does the new $3.2 billion deal include?

 

According to Pfizer, the $3.2 billion deal includes supplies of a retooled omicron-adapted vaccine, pending regulatory clearance. Drugmakers have been developing vaccines to target the omicron variant that became dominant last winter. In the new deal, the average price per dose is over $30, a more than 50% increase from the $19.50 per dose the U.S. government paid in its initial contract with Pfizer. Some of the vaccines included in the contract will be embarked for adults and will be of single dose.

U.S. Department of Health and Human Services official Dawn O’Connell said in a statement, “We look forward to taking delivery of these new variant-specific vaccines and working with state and local health departments, pharmacies, healthcare providers, federally qualified health centers, and other partners to make them available in communities around the country this fall,”

 

Change of COVID-19 Boosters

 

U.S. Food and Drug Administration advisers on Tuesday recommended a change in the design of COVID-19 booster shots for this fall in order to combat more recently circulating variants of the coronavirus.

According to a report by Reuters, “The U.S. government has distributed close to 450 million doses of the Pfizer/BioNTech vaccine in the United States since it was first authorized in December 2020, according to data from the U.S. Centers for Disease Control and Prevention. Over 350 million of those doses have been administered.

Because the Biden administration was unable to line up more COVID-19 funding from Congress earlier this month, it was forced to reallocate $10 billion of existing funding to pay for additional vaccines and treatments.”

FDA says yes to Covid-19 Vaccines for Young Children

FDA gives green signal for COVID-19 vaccines young children under the age of 5 years and as young as 6 months are going to get their Covid-19 Vaccine shots. FDA (US Food and Drug Administration) members collectively agreed on the decision that vaccines from Moderna Inc (MRNA.O) and Pfizer Inc (PFE.N)/BioNTech SE (22UAy.DE) can be used for even the youngest American children by answering yes to the question, “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine when administered as a 2-dose series (25 micrograms each dose) outweigh its risks for use in infants and children 6 months through 5 years of age?” Moreover they replied in the affirmative to this as well-, “Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine when administered as a 3-dose series (3 micrograms each dose) outweigh its risks for use in infants and children 6 months through 4 years of age?”

 

Why is Vaccines for Young Children is Necessary?

Vaccines for Young Children is indeed necessary. Though the disease is less effective in  children, FDA official Peter Marks to the panel said, “I think we have to be careful that we don’t become numb to the number of pediatric deaths because of the overwhelming number of older deaths,” Reingold, of the University of California, Berkeley said, “If we have a vaccine with benefits that outweigh the risks, then making it available to people is a reasonable choice,”

 

Expert’s suggestion

Speaking of the necessity of vaccines for young children, an associate professor of microbiology and immunology at the University of Michigan Medical School Oveta Fuller about Moderna vaccine, “The benefits seem to clearly outweigh the risks, particularly for those with young children who may be in kindergarten or in collective child care,”

 

Symptoms seen after shots

Dr. Rituparna Das, Moderna’s vice president of Covid-19 vaccines clinical development said, “Pain was the most common event,” She added, “Young children’s events included fever, headache, fatigue, myalgia, arthralgia, nausea, vomiting and chills. For infants and toddlers, events included fever, irritability, crying, sleepiness and loss of appetite.”

J&J and Emergent end agreement on Covid-19 Vaccine manufacturing

Manufacturing of Covid-19 Vaccination doses is one of the most important issues in the world of pharmaceutical companies these days. Some of the leading companies in this field are continuously trying their best to meet the rising global demand. At this high time, Johnson and Johnson and Emergent BioSolutions Inc Monday came to a decision to terminate their agreement to make the doses of Covid-19 Vaccine.

 

What is Emergent saying?

 

According to Emergent Johnson and Johnson failed to buy the minimum quantity of COVID-19 vaccines made by the company. They added that while failing to fulfill the minimum requirements of the agreement Johnson and Johnson the American multinational corporation that develops medical devices, pharmaceuticals, and consumer packaged goods, has also failed to provide required forecasts for the number of vaccines it needed.

 

What are Johnson and Johnson saying?

 

On the other hand, Johnson and Johnson stated that the information provided by Emergent BioSolutions is “false and misleading”. According to them they have sufficient capacity across their global COVID-19 vaccine manufacturing network and can continue to meet their contractual obligations to supply vaccine.

 

Emergent’s Baltimore plant paused the manufacturing of doses last year after they got to know that ingredients from AstraZeneca’s COVID-19 vaccine, also being produced there at that time, contaminated a batch of J&J’s vaccines. The contamination resulted in the destruction of key ingredients that would have amounted to roughly 400 million doses of COVID-19 vaccines from J&J and AstraZeneca. Added to that due to safety concerns the use of the COVID-19 Vaccine produced by Johnson and Johnson has been restricted by the Food and Drug Administration of the United States in May.

 

Closure of the Agreement

 

At first, J&J provided formal notice of termination and breach to Emergen. Eventually, Emergent BioSolutions said in a securities filing that it had sent a notice of material breach of the agreement to J&J.

Why did FDA rebuke Pfizer CEO’s suggestion to take more Paxlovid if COVID-19 returns?

In a piece of recent news, the FDA rebuked Pfizer CEO Albert Bourla’s proposed solution to reports that some patients experienced a relapse of COVID-19 symptoms after treatment with the company’s antiviral drug Paxlovid.

 

Rebounding Caused by Paxlovid

 

After reports said some patients who took Paxlovid rebounded and started feeling symptoms again, the CEO told that patients can take another course, “like you do with antibiotics.” “Paxlovid does what it has to do: It reduces the viral load,” Bourla, Ph.D., told Bloomberg in an interview. “Then your body is supposed to do the job.”

However, the FDA is not on board with the suggestion. In a post, John Farley, M.D., director of the Office of Infectious Diseases, said: “There is no evidence of benefit at this time for a longer course of treatment … or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course.”

Pfizer sticks to guns on $22B Paxlovid sales despite reports of lagging demand. About 80,000 US COVID-19 patients have sought treatment with the antiviral as of April 22, CNBC reports. It’s not clear how many patients have had a COVID-19 rebound after taking the full course of the treatment, but many reports of rebounds have surfaced in the last week, puzzling doctors.

 

Emergency Use Authorization

 

Pfizer received an emergency use authorization from the FDA in December to sell its antiviral, the first of its kind to fight COVID-19. Since then, the U.S. has ordered 20 million courses and is working to bolster the pill’s availability. The drug is heavily endorsed by the Biden administration and was even prescribed to Kamala Harris. Despite the accolades, it’s not in as high demand as anticipated, and it recently was found ineffective for post-exposure protection.

The pill is prescribed as a five-day course, and its directions read that it is “not authorized for use for longer than 5 consecutive days.” Paxlovid garnered Pfizer $1.5 billion in sales in the first quarter, and the company forecasts $22 billion in global sales from the product this year.

 

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