Tag: vaccine

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-Top News Kerala

Nod for proposal to study mixing of Covid-19 vaccine doses

Panel of India’s central drug authority has recommended Christian Medical College in Vellore for conducting a clinical trial of mixing of two Covid-19 vaccines — Covaxin and Covishield, reports Asian Lite News

An expert panel of India’s central drug authority has recommended granting permission to the Christian Medical College (CMC) in Vellore for conducting a clinical trial of mixing of two Covid-19 vaccines — Covaxin and Covishield — official sources said.

The panel also recommended giving approval to Bharat Biotech for carrying out a study on interchangeability of its Covaxin and the under-trial adenoviral intranasal vaccine candidate BBV154, but asked the Hyderabad-based firm to remove the word “interchangeability” from the study title and submit a revised protocol for approval.

“The SEC (subject expert committee) after detailed deliberations recommended granting permission to CMC, Vellore for conducting the phase-4 clinical trial covering 300 healthy volunteers for mixing of Covid-19 vaccines Covaxin and Covishield,” a source said.

“The aim of the study is to assess whether a person can be given two different vaccine shots — one each of Covishield and Covaxin — to complete the inoculation course,” the source said.

The expert group also discussed the application by Biological E for conducting Phase 2/3 clinical trial of its Covud-19 vaccine in the paediatric population aged 5 to 17 years, along with the safety and immunogenicity data (after dose 1) from the ongoing phase 2/3 clinical trial on adults.

“After deliberation, the committee recommended that the safety and immunogenicity data from phase 2 part of the phase 2/3 clinical trial on adults should be submitted to the CDSCO (Central Drugs Standard Control Organisation),” the source said.

It also suggested that the firm should submit the clinical trial protocol along with data for further review by the committee, the source said.

The application of Johnson and Johnson (J&J) seeking permission to conduct phase-3 clinical trial of its single-dose Covid-19 vaccine was on the agenda, but “the firm informed that they are withdrawing their proposal,” another official source said.

The US-based pharmaceutical company J&J had sought approval for conducting phase-3 clinical trial of its vaccine on approximately 600 participants in two age groups — those aged between 18 and 59 years and those aged 60 and above — to evaluate the safety, reactogenicity, and immunogenicity of the jab in healthy Indian adults.

The firm has conducted clinical trials in the USA, Brazil and South Africa.

J&J’s single dose vaccine first received the emergency use authorisation (EUA) in Bahrain on 25 February 2021. As of April 16, 2021, the vaccine has been approved in several countries/markets around the world, including the US and the EU.

Kerala’s daily Covid TPR jumps to 15.91%

Meanwhile, hovering over the 13 per cent mark for a while, the daily Covid test positivity rate in Kerala on Tuesday jumped to 15.91 per cent, Chief Minister Pinarayi Vijayan said.

In a statement issued here, he said that 21,119 people turned Covid positive after 1,32,769 samples were tested in the past 24 hours.

This is the first time in a few weeks that the daily TPR has crossed 15 per cent, while Kerala continues to have more than 50 per cent of the daily new cases in the country.

Vijayan also said that there were 1,71,985 active cases in the state after 18,493 people turned negative.

The day also saw 152 Covid deaths, taking the death toll to 18,004.

Malappuram district continues to lead in the number of daily cases, with 3,603, followed by Ernakulam with 2,539 cases.

With Kerala now heading for Onam festival season, it remains to be seen on what would be its impact as most of the restrictions have been relaxed till August 22, including lifting of triple lockdown on Sundays.

Hitherto since April, all Sundays saw triple lockdown across the state but on account of Independence Day and Third Onam falling on Sundays, there will be no lockdown.

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-Top News COVID-19 UK News

London still the most vax resistance area of UK

The sharpest decline in hesitancy was in Wales where the rate decreased from 9 per cent in March to 4 per cent in July…reports Asian Lite News.

Although the UK has witnessed a sharp decline in coronavirus vaccine hesitancy, London still remains the most vaccine resistance area of the country, a survey by the Office for National Statistics (ONS) revealed.

In the survey released on Monday, the ONS said adults from all regions of England, Scotland and Wales became less likely to report coronavirus vaccine hesitancy during the first half of 2021, but in London, the hesitancy level fell from 11 per cent to 7 per cent, reports Xinhua news agency.

“Despite the fall, Londoners remained the most vaccine hesitant among the regions and countries of Britain,” said the ONS.

London also appears to be behind other regions on vaccine uptake, it added.

At the end of June 2021, one in nine (11 per cent) adults aged 50 years and over in London had not received a coronavirus vaccine, twice the rate of any other English region.

The sharpest decline in hesitancy was in Wales where the rate decreased from 9 per cent in March to 4 per cent in July.

In Yorkshire and the Humber region of England the number halved to 4 per cent, while in north east England it fell from 7 per cent to just 3 per cent.

The ONS said in some regions of Britain, people in bad health became less likely to report vaccine hesitancy than those in good health.

“In line with trends observed across Britain as a whole, young adults, those of Black or Black British ethnicity, and the unemployed are generally the most hesitant towards vaccines in all English regions, Scotland and Wales,” said a spokesperson for ONS.

“Rates of hesitancy among these groups tended to be highest in London and the Midlands, despite falling compared with earlier in the year,” said the spokesperson.

Nearly 90 per cent of the adults in Britain have had their first dose of vaccine, while more than 75 per cent have had their second jab, according to the latest figures.

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-Top News COVID-19

Vaccine hesitancy among young falls in UK

Despite the fall in numbers, Londoners remained the most vaccine hesitant among the regions of Britain…reports Asian Lite News.

Vaccine hesitancy among the young has fallen, as a survey from the Office for National Statistics (ONS) looking at attitudes toward the jab between June 13 and July 18 showed that hesitancy in those aged 16-17 has decreased from 14 per cent to 11 per cent.

Among those aged 18 to 21, hesitancy went down to five per cent from nine per cent and there was also a slight drop for those aged 22-25 from 10 per cent to nine per cent, according to the survey.

Despite the fall in numbers, Londoners remained the most vaccine hesitant among the regions of Britain.

At the end of June 2021, one in nine (11 per cent) adults aged 50 years and over in London had not received a coronavirus vaccine, twice the rate of any other English region, according to the ONS.

Britain has reported another 25,161 coronavirus cases in the latest 24-hour period, bringing the total number of coronavirus cases in the country to 6,094,243, according to official figures released on Monday.

The country also recorded another 37 coronavirus-related deaths. The total number of coronavirus-related deaths in Britain now stands at 130,357. These figures only include the deaths of people who died within 28 days of their first positive test, the Xinhua news agency reported.

Nearly 90 per cent of the adults in Britain have had their first dose of vaccine, while almost 75 per cent have had their second jab, according to the latest figures.

To bring life back to normal, countries such as Britain, China, Russia, the US as well as the European Union have been racing against time to roll out coronavirus vaccines.

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-Top News COVID-19

No compromise on Covaxin quality, says Bharat Biotech

“Every batch of Covaxin is subjected to more than 200 quality control tests at our facilities, followed by submission samples to the Central Drugs Laboratory (CDL), Government of India, only based on approval/release by CDL, are batches released commercially,” it said…reports Asian Lite News.

Amid concerns in some quarters about the safety of Covaxin, Bharat Biotech has clarified that its Covid-19 vaccine is totally safe and that it is following uncompromising policy on safety and quality.

The Hyderabad-based company’s clarification came in view of certain media and social media reports.

The vaccine maker stated that as of date, all batches of Covaxin were manufactured and released from its manufacturing facilities at Genome Valley, Hyderabad, which are fully audited and approved by regulatory authorities.

“Every batch of Covaxin is subjected to more than 200 quality control tests at our facilities, followed by submission samples to the Central Drugs Laboratory (CDL), Government of India, only based on approval/release by CDL, are batches released commercially,” it said.

The company said since early June, manufacturing of Covaxin commenced at its sites at Malur, Karnataka, and Ankleshwar, Gujarat, prior to which engineering batches were also executed to study equipment functionality. “Products manufactured from these facilities will be available for supplies during September. This is based on our 120-day timeline for manufacturing, testing, release, regulatory approvals, and distribution,” it said.

The clarification came after Covid task force member N.K. Arora told a television channel that the supply of Covaxin has been slowed down because the first few batches at the company’s newest facility in Bengaluru were not of the right quality.

Vaccine manufacturing, testing, and release at Bharat Biotech follow validated, stringent GMP processes which were established over 20 years, with several billion doses of vaccines supplied within India and globally, Bharat Biotech said in a statement.

“Since vaccines are administered to healthy individuals, safety is always our vital, primary criteria and we have an uncompromising policy on safety, and quality, whatsoever. This is evident from the excellent safety contours of Covaxin with an impressive supply of 70 million doses to date. It is emblematic that Bharat Biotech has not sought indemnity from the Government of India for any adverse events from Covaxin.”

The vaccine maker reiterated that whole-virion Inactivated Vero Cell vaccines (Covaxin technology platform) are highly complex to manufacture as the critical ingredient is based on live viruses which require highly sophisticated, multiple level containment, and purification methods. Such extensive, high standards of purification naturally lead to significant process losses and low yields resulting in a highly purified and safe vaccine, it said.

It pointed out that the SARS COV2 strains provided under material transfer agreements to Bharat Biotech are also readily available at the ICMR-NIV and accessible to any organisation that wishes to manufacture a similar Covid-19 vaccine.

Vaccinology, vaccine manufacturing, testing, and release is a complex multifactorial science involving inputs from more than 30 scientific and technological disciplines. This is evident from the fact that since the start of the pandemic, only 2 vaccine companies have been able to supply Covid-19 vaccines to the Government of India, it said.

https://www.youtube.com/watch?v=S31IPaP4-dI

“Bharat Biotech is the only company to develop a vaccine indigenously in India and manufacture it large scale. It has accomplished this in a matter of 15 months, with 10 publications and global recognition for India as an innovator and product developer. Covaxin is the only vaccine to have demonstrated efficacy against the Delta variant in Phase 3 human clinical trials,” it said, adding that “fake news and false and misleading narratives result in unintended consequences of creating panic among people, resulting in vaccine hesitancy, extending our country’s timelines to return to normalcy and restoration of livelihoods”.

It requested media organisations and influencers to use “caution, restraint, detailed analysis in their reportage and their external communication”.

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-Top News World News

WHO calls for moratorium on booster Covid-19 vaccine shots

Tedros stressed the need for an urgent reversal of vaccination supply, saying a majority of vaccines are going to high-income countries when low-income countries have only been able to administer “1.5 syringe for every 100 people…reports Asian Lite News.

As millions of people are waiting for their first dose of the Covid-19 vaccine, the World Health Organization (WHO) on Wednesday called for a moratorium on booster shots until September end. WHO director-general Tedros Adhanom Ghebreyesus highlighted the vaccine disparity as rich countries are moving swiftly to plan booster doses for their citizens.

Tedros told a press briefing that 80% of the vaccine doses administered globally have gone to high- and upper-middle-income countries, while low- and lower-middle-income countries are struggling to vaccinate even their healthcare workers and high-risk groups. He stressed that hundreds of millions of unvaccinated people require Covid-19 vaccines urgently as they cannot afford to stay home.

https://twitter.com/DrTedros/status/1423023291426648075

“I understand the concern of all governments to protect their people from the Delta variant. But we cannot accept countries that have already used most of the global supply of vaccines using even more of it, while the Earth globe Europe-Africa’s most vulnerable people remain unprotected,” the WHO chief said.

Tedros stressed the need for an urgent reversal of vaccination supply, saying a majority of vaccines are going to high-income countries when low-income countries have only been able to administer “1.5 syringe for every 100 people.” Referring to his earlier call for global support to enable countries to vaccinate at least 10% of their population, the WHO chief lamented that they aren’t on track to achieve the target.

“Accordingly, WHO is calling for a moratorium on boosters until at least the end of September, to enable at least 10% of the population of every country to be vaccinated,” Tedros said, adding that the plan needs the cooperation of a “handful of countries and companies that control the global supply of vaccines.”

Underscoring the importance of G20 countries in fighting the pandemic, Tedros said that the “course of the pandemic depends on the leadership of the G20 countries.” He also urged everyone with “influence”, including Olympics athletes and business and faith leaders, to call for the moratorium on booster shots.

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-Top News COVID-19 USA

US trying to help India to produce vaccine, says Biden

With a need for several billion doses around the world, the US was committed to provide half a billion, reports Asian Lite News

The United States is helping India and other countries to be able produce the vaccines by themselves, President Joe Biden has said.

With a need for several billion doses around the world, the US was committed to provide half a billion, Biden said during a press conference at White House on Tuesday.

“We have committed to over a half a billion doses. And we’re trying to provide for more and provide for the capacity of countries like India to be able to produce the vaccine themselves. And we’re helping them do that. That’s what we’re doing now,” he said in response to a question.

“And we’re trying to…by the way, it’s free. We’re not charging anybody anything. And we’re trying to do as much as we possibly can,” he added.

In this fight against Covid-19, Biden asserted, the United States was committed to become the “arsenal of vaccines”, the manner in which it was the arsenal of democracy during World War II.

“We are backing up that commitment. We have contributed more than any other nation to COVAX as a collective global effort to deliver COVID-19 vaccines across the world. We have supported manufacturing efforts abroad through our partnerships with Japan, India, Australia – known as the Quad,” he said.

Biden said that during his trip to Europe in June, he had announced that the US would purchase a ground-breaking 500 million doses of Pfizer and donate to nearly a hundred low-and middle-income countries that don’t have the vaccine. Those doses will start to ship at the end of this month, he said.

“We also announced that we would donate 80 million doses of our own vaccine to supply the world, which has already begun,” Biden said, adding that so far, the US has shipped over 110 million doses of its vaccines to 65 countries, which are among the hardest-hit in the world.

“We will continue to give tens of millions of the doses away across the summer and work to increase US manufacturing and manufacturing of vaccines around the world as well. It is not just vaccines. We are continuing to provide countries in need with more testing, protective equipment, and personnel to stem the surge of the virus. We have done it in India and elsewhere,” the President said.

“In the race for the 21st century between democracies and autocracies, we need to prove that democracies can deliver. The democracies of the world are looking to America to lead again in two ways. First, to demonstrate we can control this virus at home. And second, to show we can help address it around the world. Vaccinate America and help vaccinate the world. That’s how we are about to beat this thing,” he added.

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-Top News COVID-19 USA

US hits 70% Covid vaccination goal amid resurgence

The current seven-day average of daily new cases increased 64.1 per cent compared with the previous seven-day data…reports Asian Lite News

Seventy per cent of US adults have had at least one shot of a Covid-19 vaccine amid an ongoing resurgence of new cases attributed to the highly transmissible Delta variant, according to data published by the Centers for Disease Control and Prevention (CDC).

The milestone came about a month behind President Joe Biden’s Fourth of July goal. As of Monday, 70 per cent of US adults ages 18 and older have received at least one vaccine dose while 60.6 per cent of American adults are fully vaccinated, according to the CDC.

The current seven-day average of daily new cases increased 64.1 per cent compared with the previous seven-day data, it said.

Nationally, the proportion of cases attributed to B.1.617.2 (Delta) is predicted to increase to 82.2 per cent.

Monday’s data comes almost a week after the CDC reversed course on its prior guidance and recommended fully vaccinated Americans who live in areas with high Covid infection rates resume wearing face masks indoors.

The guidelines cover about two-thirds of the US population, according to a CNBC analysis.

While the delta variant hits unvaccinated people the hardest, some inoculated people could be carrying higher levels of the virus than previously understood and could transmit it to others, CDC Director Rochelle Walensky said last week.

She added that the variant behaves “uniquely differently from past strains of the virus”.

As of Tuesday morning, the US continued to be the worst-hit country with the world’s highest number of cases and deaths at 35,129,562 and 613,670, respectively, according to the Johns Hopkins University.

Situation going to get worse: Fauci

As the more contagious Delta variant of the novel coronavirus is spreading across the US, Anthony Fauci, White House chief medical advisor, has warned that “things are going to get worse.”

“We are looking, not I believe, to lockdown but we are looking to some pain and suffering in the future because we are seeing the cases go up,” Fauci, director of the US National Institute of Allergy and Infectious Diseases, said Sunday, according to a report from the Wall Street Journal, the Xinhua news agency reported.

“The solution to this is, get vaccinated,” he said.

The latest data from the US Centers for Disease Control and Prevention showed a 64.1 per cent increase in Covid-19 cases in the country over the week ended July 30 compared with the previous week, or an average of 66,606 cases a day.

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-Top News COVID-19 World News

Pfizer, Moderna raise Covid-19 vaccine prices in EU


The supply contracts are being renewed as Europe is anxious to secure supplies for potential booster shots in the face of the spread of the highly infectious Delta variant…reports Asian Lite News.

US drug makers Pfizer and Moderna have increased the prices of their mRNA-based vaccines against Covid-19 for the European market, the media reported.

According to the new contracts, a Pfizer shot will now cost 19.50 euros against 15.50 euros previously, while a Moderna jab has been priced at 21.49 euros a dose, from about 19 euros in the first procurement deal, The Financial Times reported.

The supply contracts are being renewed as Europe is anxious to secure supplies for potential booster shots in the face of the spread of the highly infectious Delta variant.

Further, the terms of the deals, struck this year for a total of up to 2.1 billion shots until 2023, were renegotiated after phase 3 trial data showed the two companies’ mRNA vaccines had higher efficacy rates than shots developed by Oxford/AstraZeneca and Johnson & Johnson, the report said.

The companies had capitalised on their market power and deployed the “usual pharma rhetoric… Vaccines work so they increased the ‘value’,” the report quoted an official close to the negotiations official.

Riding on the success of its Covid vaccine, Pfizer, last week, raised its annual vaccine revenue to $33.5 billion in 2021, up from the previously projected $26 billion.

Prices for higher-income countries were “comparable”, with middle-income countries charged about half and lower-income countries paying cost, Chief executive Albert Bourla was quoted as saying.

Moderna is expected to announce the second quarter financial results this week. According to forecasts compiled by Airfinity, a life sciences consultancy, the sales of Pfizer’s Covid jab will hit 47.1 billion euros with Moderna’s reaching 25.2 billion euros, the FT reported.

On the other hand, sales of Oxford/AstraZeneca’s Covid jab — the largest vaccine supplied to low-income countries — is expected to rise to 12.6 billion euros in 2022, it added.

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-Top News Arab News Saudi Arabia

Saudi Arabia to welcome vaccinated tourists from Aug 1

Fully vaccinated tourists can enter the Kingdom without the need for an institutional quarantine period, provided that an official vaccination certificate is presented upon arrival…reports Asian Lite News

The Saudi Ministry of Tourism announced that the Kingdom will open its doors to foreign tourists, and lift off the suspension of entry for tourist visa holders, starting from August 1, 2021.

Fully vaccinated tourists can enter the Kingdom without the need for an institutional quarantine period, provided that an official vaccination certificate is presented upon arrival, and proof of a PCR test with its negative result within 72 hours from the time of departure.

Visitors to the Kingdom are also required to register their data related to vaccination doses via the new dedicated portal – https://muqeem.sa/#/vaccine-registration/home – in addition to registering their data via “Tawakkalna” application, which is mandatory to enter public places.

Those who are fully vaccinated are those who received two vaccination doses of one of the approved vaccines in the Kingdom, which is Pfizer, AstraZeneca or Moderna, or one dose of Johnson & Johnson.

Those wishing to obtain a tourist visa can apply through the “Spirit of Saudi” website, visitsaudi.com.

On this occasion, the Minister of Tourism, Ahmed Al-Khateeb, said: “We welcome tourists again, and we are very happy to receive the Kingdom’s guests again after a pause due to the repercussions of the Coronavirus pandemic.”

He added: “We focused our efforts during the pause on close cooperation with our partners in all sectors to ensure a safe return through which visitors to the Kingdom can enjoy exploring its tourist treasures, important destinations and landmarks, enjoy unique tourist experiences and learn about the culture of generosity and hospitality characterizing Saudi society.”

The Kingdom had launched the tourist visa in September 2019, in a historic decision in which the Kingdom opened its heart and its doors to tourists from different countries of the world.

At that time the Kingdom had achieved remarkable numbers as 400,000 visas were issued within 6 months, before the suspension of travel and the closure of ports and borders following the pandemic of coronavirus.

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Categories
-Top News COVID-19 USA

Pfizer recommends 3rd Covid shot for Delta variant

Vials of the Pfizer-BioNTech vaccine

Pfizer anticipates applying for emergency use authorization for a third dose of its vaccine as soon as next month…reports Asian Lite News

 American biopharmaceutical company Pfizer has said a third dose of its Covid-19 vaccine can “strongly” boost protection against the Delta variant.

Antibody levels against the Delta variant in people aged 18 to 55 who receive a third dose of the Pfizer/BioNTech vaccine are greater than five-fold than following a second dose, according to data posted at the company’s teleconference, Xinhua reported.

Among people aged 65 to 85, the Pfizer data suggest that antibody levels against the Delta variant after receiving a third dose are greater than 11-fold than following a second dose.

Pfizer anticipates applying for emergency use authorization for a third dose of its vaccine as soon as next month, Mikael Dolsten, who leads worldwide research, development and medical for Pfizer, was quoted by CNN as saying at the teleconference.

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