Covid-19 treatments updates

[ghazi52]

Denmark approves treatment with Merck's Covid-19 tablet

Danish health authorities have approved treatment with Merck & Co Inc's molnupiravir tablet for Covid-19 patients at risk of serious illness, including the elderly.

The medication has yet to be approved by the European Medical Agency, which in late November started reviewing USdrugmaker Merck's experimental Covid-19 antiviral pill for adults and said it could issue an opinion within weeks.
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AstraZeneca antibody cocktail works against Omicron in study

AstraZeneca has said a lab study of its Covid-19 antibody cocktail, Evusheld, found that the treatment retains neutralising activity against the Omicron coronavirus variant, showing promise for wider use of the therapy.

The study was conducted by independent investigators of the US Food and Drug Administration, the company said, according to Reuters.

AstraZeneca said more analyses of Evusheld against Omicron are being conducted by the company and third parties, with data expected “very soon”.

 

[ghazi52]

Dec 20, 01:10
Dutch streets deserted as snap Christmas lockdown starts

Dutch urban centres were largely deserted on Sunday as the country began a snap lockdown that, aimed at stemming an expected Covid-19 surge caused by the fast-spreading Omicron variant, left people's Christmas plans in disarray.

Prime Minister Mark Rutte announced the shutdown on Saturday evening, ordering the closure of all but essential stores, as well as restaurants, hairdressers, gyms, museums and other public places from Sunday until at least Jan. 14.

In Rotterdam, police used a water cannon to disperse a group of around 1,000 people who had gathered outside the city's main soccer stadium, ahead of a clash between local team Feyenoord and bitter rivals Ajax Amsterdam.

 

[ghazi52]

Moderna booster shot increases antibody levels against Omicron, company says

By Jacqueline Howard, CNN

December 20, 2021

(CNN) Biotechnology company Moderna announced Monday that preliminary data suggests its half-dose booster shot increased antibody levels against Omicron compared with the levels seen when a fully vaccinated person does not receive a booster -- and a larger-sized dose of the booster increases antibody levels even more.

Currently, Moderna's booster is administered as a 50-microgram dose. The company announcement noted that its 50-microgram booster dose increased antibody levels 37-fold and a 100-microgram booster dose increased antibody levels 83-fold compared with levels seen before a booster. It remains unclear what these increases mean as far as how well the booster doses clinically work against Omicron.

But in the company's statement, CEO Stéphane Bancel called the data "reassuring."

"The dramatic increase in COVID-19 cases from the Omicron variant is concerning to all. However, these data showing that the currently authorized Moderna COVID-19 booster can boost neutralizing antibody levels 37-fold higher than pre-boost levels are reassuring," Bancel said in the announcement.

'Boost everybody.' CEOs should mandate boosters before returning office workers, Andy Slavitt says

"To respond to this highly transmissible variant, Moderna will continue to rapidly advance an Omicron-specific booster candidate into clinical testing in case it becomes necessary in the future. We will also continue to generate and share data across our booster strategies with public health authorities to help them make evidence-based decisions on the best vaccination strategies against SARS-CoV-2."

SARS-CoV-2 is the name of the coronavirus that causes Covid-19.

According to the US Centers for Disease Control and Prevention, about 32% of fully vaccinated adults have received a booster dose so far. Separately, Moderna and other vaccine makers have said that they are working on variant-specific booster shots as well.

Covid-19 booster shots can help improve protection against the Omicron coronavirus variant and there is no need for a variant-specific booster dose at this time, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said during a virtual White House briefing on Wednesday.

"A number of studies have been done throughout the country and the world to take a look at how we might prepare in the context of vaccinations," Fauci said.

"The message remains clear: If you are unvaccinated, get vaccinated," added Fauci, the chief medical adviser to President Biden. "And particularly in the arena of Omicron, if you are fully vaccinated, get your booster shot."

 

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Sputnik V due to submit vaccine data to WHO by end December

The Russian maker of the Covid-19 Sputnik V vaccine is due to submit its latest data by the end of December, with manufacturing site inspections expected to follow in February, a World Health Organisation (WHO) official has said, according to Reuters.

Rogerio Gaspar, WHO regulation director, gave the new timelines for the vaccine made by the Gamaleya Institute at a WHO briefing for journalists in Geneva.

 

[Imran Khan]

i will take my third dose tomorrow corona tera kaakh na ravee

 

[ghazi52]

EU regulator approves Novavax COVID-19 vaccine

https://nation.com.pk/NewsSource/haber
Anadolu
December 20, 2021


The European Medicines Agency (EMA) on Monday recommended the coronavirus vaccine developed by US biotechnological company Novavax for marketing authorization.

"EMA has recommended granting a conditional marketing authorization for Novavax’s COVID-19 vaccine Nuvaxovid to prevent COVID-19 in people from 18 years of age," the EU agency said in a press statement.

After evaluating scientific data on two main clinical studies involving a total of 45,000 people, the EMA concluded that the jab "met EU criteria for efficacy, safety and quality," it added.

Studies showed 90% efficacy for the vaccine in preventing COVID-19 infection.
After the EU drug regulator's green light, it is for the European Commission to officially grant the marketing authorization.

Nuvaxovid is a protein-based vaccine that prepares the body's immune system to defend against COVID-19 by using a tiny protein particle of the virus produced in a laboratory.

After vaccination, people start to produce antibodies and immune cells that can kill the virus.

The European Commission signed an advanced purchase agreement with Novavax in August for 200 million vaccines to be delivered between 2021 and 2023.

After the Pfizer-BioNTech, Moderna, AstraZeneca, and Johnson&Johnson COVID-19 vaccines, this was the fifth vaccine authorized by the EU regulator.

 

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No country can boost its way out of pandemic: WHO chief

The World Health Organisation (WHO) chief warned that the rush in wealthy countries to roll out additional Covid-19 vaccine doses was deepening the inequity in access to jabs that is prolonging the pandemic.

The UN health agency has long warned that the glaring inequity in access to Covid-19 vaccines, which has left many vulnerable people in poorer nations without a single jab as richer countries roll out broad booster programmes.

“Blanket booster programmes are likely to prolong the Covid-19 pandemic, rather than ending it, by diverting supply to countries that already have high levels of vaccination coverage, giving the virus more opportunity to spread and mutate,” WHO Director General Tedros Adhanom Ghebreyesus told reporters.

 

[ghazi52]

Philippines approves Merck's Covid-19 pill for at-risk patients

The Philippines has approved emergency use of Merck & Co Inc's Covid-19 treatment pill for adult patients at risk of developing severe illness as it tries to boost the country's arsenal of drugs to fight new variants, Reuters reports.

It also approved the Pfizer-BioNTech Covid-19 vaccine for children aged 5-11 so the vaccine, which will be administered in a paediatric formulation, could be administered once it becomes available, its Food and Drug Administration (FDA) chief said.

FDA chief Rolando Enrique Domingo told a public briefing the benefits outweighed the risks and it was already being used for children in countries like the United States and Canada.

 

[ghazi52]

The US on Thursday authorised Merck & Co's antiviral pill for Covid-19 for certain high-risk adult patients, a day after giving a broader go-ahead to a similar but more effective treatment from Pfizer Inc.

The US Food and Drug Administration (FDA) said Merck's drug, which is designed to introduce errors into the genetic code of the virus, could be used when other authorised treatments are not accessible or clinically appropriate.

The drug, molnupiravir, was developed with Ridgeback Biotherapeutics and shown to reduce hospitalisations and deaths by around 30 per cent in a clinical trial of high-risk individuals early in the course of the illness.

The authorisation allows the use of the drug for mild-to-moderate Covid-19 and along with the Pfizer pill, it could be an important tool against the fast-spreading Omicron variant, which is now dominant in the US.

Pfizer's drug, Paxlovid, was authorised on Wednesday for people aged 12 and older and has shown to be nearly 90pc effective in preventing hospitalisations and deaths in patients at high risk of severe illness, according to trial data.

The FDA says some patients should avoid Pfizer two-drug regimen because it includes an older antiviral called ritonavir that is known to have interactions with some other prescription medicines. It is also not recommended for people with severe kidney issues.

Merck plans to ship hundreds of thousands of treatment courses in coming days and one million over the next few weeks. Pfizer plans to ship about 250,000 courses in the next month.

Availability of other treatments is the first consideration for doctors thinking of prescribing Merck's treatment, according to Patrizia Cavazzoni, the director of FDA's Centre for Drug Evaluation and Research.

The FDA has authorised intravenous treatments, mostly for hospital use, called monoclonal antibodies but availability is limited and efficacy against the Omicron variant is lower.

FDA official John Farley said during a press briefing that GlaxoSmithKline's and Vir Biotech's antibody drug — which has been shown to work against Omicron — is expected to be in short supply this winter.

Merck said that its treatment had advantages over the Pfizer pill.

“It doesn't require any second drug to boost its efficacy, and you can give it in a variety of special patient populations, including people who have significant issues with liver function or kidney function,” Nick Kartsonis, Merck's senior vice president of clinical research for vaccines and infectious diseases, told Reuters.

Merck's drug is not authorised for use in patients younger than 18 because molnupiravir may affect bone and cartilage growth, the FDA said. The pill is not recommended for use during pregnancy, the agency added.

The agency advised that men of reproductive potential use a reliable method of birth control during treatment with molnupiravir, and for at least three months after the final dose.

The drug is meant to be taken twice a day — four pills each time — for five days, making a full treatment course of 40 pills.

The treatment was priced at about $700 per course in a deal with the US government for up to 5m courses.

The US government has ordered 10m courses of the Pfizer drug at a price of $530 per course compares to the deal with Merck for as many as 5m courses of molnupiravir at a price of $700 per course.

Paul Schaper, Merck's head of global public policy, said the company will ship hundreds of thousands of treatment within several days and million courses of treatment within several weeks in the US.

Merck has said molnupiravir, which helps prevent the virus from replicating, should be effective against any variant, including the new Omicron variant.

 

[ghazi52]

About 7 million adults in the US are immune-compromised and could benefit from Evusheld, according to its manufacturer, AstraZeneca. The federal government has contracted for only enough doses to treat 700,000 people.



There's a new drug to prevent Covid-19, but there won't be nearly enough for Americans who are...
cnn.com

 

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Sputnik

December 28, 2021

The Russian antiviral can also alleviate the symptoms and drastically decrease the duration of the coronavirus disease, while the pathogen cannot develop resistance to the drug.

Pharmaceutical company ChemRar Group has announced that the Russian antiviral drug Avifavir, based on favipiravir, is effective against different variants of COVID-19, such as Delta and Omicron, due to the drug being able to affect the replication systems of an RNA virus, which are highly conservative and mutation-resistant.

According to a press release issued by the company, clinical trials have also confirmed that the coronavirus cannot develop resistance to the drug, and that the antiviral can alleviate the symptoms of the afflicted and decrease the duration of the disease by half when compared to standard therapy.

"Having accumulated extensive experience with Avifavir in patients infected with COVID both from clinical trials and real-world clinical practice, we see that taking Avifavir in the first 3–5 days after infection leads to a milder disease in most cases and prevents hospitalisation", said Elena Yakubova, ChemRar Group’s medical director.

"Over the past 17 months, more than 4 million patients have been treated with favipiravir worldwide. The product was well tolerated with no new adverse events, which confirms the high safety of favipiravir".

Former US CDC Director Robert Redfield also noted that Avifavir "has been shown to be effective against COVID-19 in clinical trials and medical practice", and suggested that studying the combination of the drug "with other antivirials such as Paklovid (Pfizer) could offer even better therapeutic options for those at higher risk of COVID-19 disease progression, reduce the likelihood of drug-resistant virus mutations, and increase the time after diagnosis when therapy can be effective".

Antiviral medication Avifavir was developed and released by ChemRar Group with the support of the Russian Direct Investment Fund in June 2020, becoming the world’s first anti-COVID drug.

 

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India committee recommends emergency use authorisation for Merck's Covid-19 pill

An expert committee of India's drug regulator has recommended emergency use authorisation (EUA) for Merck's Covid-19 pill molnupiravir, and Serum Institute of India's Covovax and Biological E's corbevax vaccines, the Economic Times reported.

The recommendations by the subject expert committee have been sent to the Drugs Controller General of India, which will soon decide on their approval, according to the report.

Data presented for Covovax, the Indian version of Novavax Inc's Covid-19 vaccine, was satisfactory, the report said.

 

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Israel's Oramed gets Vietnam pre-order for 10 mln COVID-19 vaccine doses

By Steven Scheer

Nadav Kidron, CEO and co-founder of Oramed, an Israeli pharmaceutical company working to approve its experimental oral insulin drug, poses for a picture at his office in Jerusalem June 13, 2016. REUTERS/Ammar Awad

JERUSALEM, Dec 29 (Reuters) - Israel's Oramed Pharmaceuticals (ORMP.O) said on Wednesday its Oravax Medical unit signed a deal with Vietnam's Tan Thanh Holdings for the pre-order of 10 million doses of its oral COVID-19 vaccine that is in clinical trials.

 

[ghazi52]

PIA airlifts new batches of 11 million doses of Sinovac vaccine from China for Pakistan..

 

[ghazi52]

J&J booster slashes Omicron hospitalisations -S.African study

By Wendell Roelf


CAPE TOWN, Dec 30 (Reuters) - A booster dose of Johnson & Johnson Inc's (JNJ.N) single-dose COVID-19 vaccine was 84% effective at preventing hospitalisation in South African healthcare workers who became infected as the Omicron variant spread, researchers said on Thursday.