Tag Archives: COVID-19 vaccine

Janssen Vaccine could be Rolled Out in Europe by March 15

The European Medicines Agency (EMA) has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V. Janssen is a subsidiary of the giant pharma-company Johnson & Johnson.

EMA’s human medicines committee (CHMP) will assess the vaccine, known as COVID-19 Vaccine Janssen, under an accelerated timetable. The Committee could issue an opinion by the middle of March 2021, provided the company’s data on the vaccine’s efficacy, safety and quality are sufficiently comprehensive and robust.

Such a short time for evaluation is only possible because EMA has already reviewed some data during a rolling review. During this phase, EMA assessed quality data and data from laboratory studies which looked at how well the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2 (the virus that causes COVID-19). The Agency also looked at clinical safety data on the viral vector used in the vaccine.

EMA is now assessing additional data on the efficacy and safety of the vaccine as well as its quality. If EMA concludes that the benefits of the vaccine outweigh its risks, it will recommend granting a CMA. The European Commission will then issue a decision on whether to grant a CMA valid in all EU and EEA Member States within days.

This is the fourth CMA application for a COVID-19 vaccine since the start of the current pandemic. It comes after EMA’s evaluation of vaccines from BioNTech/Pfizer, Moderna and AstraZeneca. These vaccines are now authorised in the EU and are among the tools Member States are using to combat COVID-19.

Source: https://www.ema.europa.eu/

The Vaccination against Covid-19 Prevents the Transmission of the Virus

A growing body of evidence suggests that the Covid-19 vaccine can slow the spread of the coronavirus, Dr. Anthony Fauci said Wednesday. Whether vaccination can prevent transmission of the virus is “the looming question,” Fauci, director of the National Institute of Allergy and Infectious Diseases, said during a White House coronavirus response team briefing.

If a person gets infected despite being vaccinated — we refer to that as a ‘breakthrough’ infection — does that person have the capability of transmitting to another person?” “There have been some studies that are pointing in a very favorable direction,” he said, adding that these studies will have to be corroborated by additional research.

Fauci highlighted two recent studies that looked at a person’s viral load — that is, how much virus he or she has in the body — and transmissibility. One study from Spain, published Feb. 2 in The Lancet, found a direct correlation between viral load and transmissibility. The higher the viral load, the greater the transmissibility of the virus.

That’s in line with what years of research on HIV have shown: there’s a direct link between the viral load in someone’s blood and the likelihood that individual will transmit HIV to a sexual partner, Fauci said.

For SARS-CoV-2, the virus that causes Covid-19, researchers are focused on how much virus is found the nasopharynx, the upper part of the throat behind the nose that’s reached with a long, skinny swab.

https://www.nbcnews.com/

From Tobacco Plant To 100% Efficient COVID Vaccine

Under a winter’s snow cover on the outskirts of Quebec City in Canada, a high-tech greenhouse, set at a balmy 23 C, is growing row after row of a weed that could help end the coronavirus pandemicIt’s called Nicotiana benthamiana, a relative of the tobacco plant, native to Australia, and it is a key to biopharmaceutical company Medicago’s COVID-19 vaccineMedicago is the leading Canadian-based contender to produce a vaccine, with an agreement to provide the federal government with 76 million doses if approved for use.

Medicago’s vaulting onto the mainstage could provide a breakthrough for vaccine science. It involves a new technology that’s rapid and nimble, and a vaccine that can be stored at normal fridge temperatures, of 2 C to 8 C, unlike the two other vaccines currently in circulation, which each require frozen or ultra-cold frozen storage. While it’s possible the company may emerge as the new wunderkind of the Canadian biotech sector, it wasn’t without adversity. For years, Medicago warned that Canada needed to prepare itself for a pandemic and lobbied government officials for funding to build a domestic manufacturing site for a vaccine. But Medicago didn’t get what it needed from the federal government until after the COVID-19 crisis struck. On top of that, in the middle of a pandemic, Medicago is restructuring. In July, it announced plans to distance itself from a significant shareholder, Philip Morris International, which owns about one-third of the company — a controversial association with Big Tobacco that has been the source of roadblocks and criticism. Then in December, the company replaced its president and CEO. But despite this, Medicago hasn’t lost sight of its goal: a vaccine.

In phase one of its clinical trials, 100 per cent of people who received its COVID-19 vaccine developed significant antibody responses with no severe adverse effectsPhase two clinical trials are currently wrapping up and phase three is expected to begin later this month. It will involve 30,000 people in 11 countries — including Canada — and will ultimately determine if the vaccine protects people from COVID-19. The vaccine requires two doses, 21 days apart, and if approved by Health Canada, could be in the arms of Canadians by the second half of this year.

Source: https://globalnews.ca/

Chinese Covid-19 Vaccine Ready For Public By November

Chinese manufacturers have been bullish about development, with companies Sinovac Biotech and Sinopharm even putting their vaccine candidates on display at a trade fair in Beijing this month. A China-developed coronavirus vaccine could be ready for the public as early as November, a Chinese official has told state television, as the global race to clear the final round of trials heats up.

Representatives of the firms told AFP that they hope their vaccines will be approved after phase 3 trials as early as year-end.

And on late Monday, the chief biosafety expert at the Chinese Centre for Disease Control told state broadcaster CCTV that a vaccine would be available to the general public “around November or December.”
https://medicalxpress.com/

Sinovac COVID-19 Vaccine Available To Brazilians In December

The governor of Brazil’s São Paulo State said on Wednesday that Phase 3 clinical trials of a potential COVID-19 vaccine developed by China’s Sinovac Biotech Ltd have shown promising results and it may be available to Brazilians as early as December.
Governor João Dória added that Phase 2 trials of the potential vaccine had shown an immune response of 98% in the elderly. Some 9,000 Brazilians are participating in the Sinovac vaccine trials, which are being conducted by the Butantan Institute in Sao Paulo city, the State capital. Brazil, which has the third worst outbreak of the novel coronavirus in the world after the United States and India, has become a testing ground for at least two vaccine candidates.

Brazil trials of Sinovac COVID-19 vaccine show promising results
One such vaccine is being developed by AstraZeneca, which has had to pause global trials after an unexplained illness in a participant in Britain. At the start of next year, Phase 3 trials of Russia’s “Sputnik-VCOVID-19 vaccine will also be conducted on 10,000 volunteers in Brazil in partnership with the State of Paraná’s Technology Institute, known as Tecpar.

Source: https://timesofindia.indiatimes.com/

Russian COVID-19 vaccine approval imminent

Russia’s first potential COVID-19 vaccine will win local regulatory approval in the first half of August and be administered to frontline health workers soon afterwards, a development source close to the matter told Reuters. A state research facility in Moscow – the Gamaleya Institute – completed early human trials of the adenovirus-based vaccine this month and expects to begin large-scale trials in August.

The vaccine will win regulatory approval from authorities in Russia while that large-scale trial continues, the source said, highlighting Moscow’s determination to be the first country in the world to approve a vaccine. The speed at which Russia is moving to roll out the vaccine has prompted some Western media to question whether Moscow is putting national prestige before solid science and safety.

(Regulatory) approval will be in the first two weeks of August,” the development source said. “August 10 is the expected date, but it will definitely be before August 15. All (trial) results so far are highly positive.”

The source added that Russian health workers treating COVID-19 patients will be offered the chance of volunteering to be vaccinated soon after the vaccine receives the regulatory approval. Separately, Russia’s Interfax news agency cited “an informed source” as saying the vaccine would be registered from Aug. 10-12 and be administered from Aug. 15 onwards.

https://reuters.com/

China’s Phase 2 Trial Finds COVID-19 Vaccine Safe, Inducing Immune Response

A phase 2 trial of a COVID-19 vaccine candidate conducted in China has found that the vaccine is safe and induces an immune response, according to a new study published Monday in medical journal The Lancet.
The results provide data from a wider group of participants than the phase 1 trial, which was published in May. Phase 1 trial involved 108 healthy adults and it demonstrated promising results.

The phase 2 trial adds further evidence on safety and immunogenicity in a large population than the phase 1 trial. This is an important step in evaluating this early-stage experimental vaccine and phase 3 trials are now underway,” said Professor Fengcai Zhu from Jiangsu Provincial Center for Disease Control and Prevention, China.
According to The Lancet, the trial of the Ad5 vectored COVID-19 vaccine candidate was conducted in the central Chinese city of Wuhan with 508 participants taking part. Approximately two thirds of participants were aged 18-44 years, with a quarter aged 45-54 years, and 13 percent aged 55 years or older.
http://www.xinhuanet.com/