I’m delighted for Darren, Linda and all the thousands of Novavax trial volunteers left in limbo for months as their very effective vaccine was not recognised for months. Now they can travel again. Important to look after these unsung heroes of the pandemic www.bbc.co.uk/news/health-58844369
Question for the COVID experts - I have several friends who were in the @Novavax vaccine trial and have unblinded/dropped out and are getting no guidance. What should they do?
09 October, 2021 - 05:21pm
Trial participants have described feeling trapped and in limbo because they were unable to get a licensed Covid-19 vaccine, hindering their ability to leave the UK for business or pleasure.
But after taking advice from the Joint Committee on Vaccination and Immunisation (JCVI), the Department of Health and Social Care (DHSC) said those in England who took part in the UK-based Novavax trial should be offered two doses of the Pfizer/BioNTech jab, with eight weeks between the doses.
The health administrations in Scotland, Wales and Northern Ireland are expected to follow suit for vaccine trial participants in their regions.
More than 15,000 people took part in the phase 3 Novavax trial at various hospital sites across the UK, but the company has not yet submitted data to regulators to get the jab approved.
The UK already recognises those in Covid vaccine clinical trials as being fully vaccinated for the purpose of certification, both domestically and internationally. However, most other countries do not recognise clinical trial volunteers and require visitors to have been fully vaccinated with a vaccine that has been approved for deployment by the relevant medicines regulator.
Sajid Javid, the health secretary, appealed to global health leaders last month at the G20 meeting for clinical trial pioneers to have their vaccine status recognised globally. But with them refusing to shift their position, it has meant thousands of people continue to be unable to easily travel abroad.
The offer of two doses of Pfizer from next week means people will be able to travel more freely and have two doses of an approved Covid-19 vaccine on their health records, as well as via the NHS app. People will be able to get their extra vaccines following a discussion with an investigator from the Novavax clinical trials team.
The offer of two further vaccines will also be rolled out to participants in other relevant vaccine trials this month, the DHSC said.
No evidence exists to date on administering four doses of different vaccines, although experts do not expect significant issues. However, there is evidence that mixing three doses of different vaccines is safe, as set out in the Cov-Boost vaccine trial.
Prof Jonathan Van-Tam, England’s deputy chief medical officer, said: “Covid-19 vaccine trials have been absolutely integral to our response to the virus, and as a result we now have our renowned vaccination programme, which continues to save lives. I urge as many people as possible to continue contributing to these trials.
“The measures we have taken will allow UK Covid-19 vaccine trial participants to travel freely overseas once they have had the additional vaccinations. We should be very clear that the results from these trials benefit the whole world, and it has to be said that if more countries around the world had reciprocated by allowing UK volunteers to enjoy fully vaccinated status for overseas travel, these measures would not have been necessary.”
Prof Paul Heath, the principal investigator of the Novavax clinical trial across 35 sites, said: “For too long the participants have been disadvantaged in terms of international travel because this vaccine is not yet approved for deployment, but trial participants now have the flexibility to receive booster doses, or additional doses for travel purposes, if they wish to.”
Dale Moody, a Novavax trial volunteer, said he welcomed the move. “I am both relieved and elated about the decision to let Novavax volunteers have an approved vaccine for travel or as a booster,” he said. “It is a load off my mind.
“I was concerned that we had been cast aside. I had my second dose of Novavax in November last year and was worried about not getting a booster vaccine.”
Moody, 69, of Market Drayton in Shropshire, added: “I have family in Australia and was concerned that the uncertainties about the approval timescale of Novavax would prohibit visiting my family out there.”
08 October, 2021 - 09:56pm
The digital divide caused by online classes will defeat the fundamental right of every poor child to study in mainstream schools, the Supreme Court warned on October 8. The court rued how the right to education of little children now hinges on who can afford “gadgets” for online classes and who cannot.
Little children whose parents are too poor to afford laptops, tablets or an “optimum” Internet package at home for online classes during the pandemic have dropped out of school and even run the danger of being drawn into child labour or worse, child trafficking, the court said.
The Supreme Court on October 8 prima facie did not approve of hybrid court hearings, which is a combination of physical and virtual mode of court proceedings, as a permanent feature. The court said virtual mode of hearings was started exclusively to meet the extraordinary circumstances of the pandemic.
Here are the latest updates:
COVID-19 containment can derail if festivals are not celebrated following protocols, Union Health Minister Mansukh Mandaviya warned on Saturday and exhorted 19 States to escalate their inoculation pace so that India can achieve administering 100 crore vaccine doses in the next few days.
India has so far administered over 94 crore Covid vaccine doses.
Reviewing the progress of COVID-19 vaccination with principal secretaries and mission directors of the National Health Mission from all major States, Mr. Mandaviya underlined that administering 100 crore doses of COVID-19 vaccine is the immediate milestone in India's inoculation journey.
Russia has recorded a new record-high daily death toll from COVID-19, continuing a persistent rise that has brought new records almost daily in October.
The national coronavirus task force reported Saturday that 968 people in Russia died of COVID-19 over the past day — about 100 more daily deaths than were recorded in late September. The task force said more than 29,000 new infections also were confirmed in the past day.
Authorities blame the steep rise on the country's low vaccination rate. Deputy Prime Minister Tatyana Golikova said Friday that 47.8 million Russians, or almost 33% of Russia’s nearly 146 million people, had received at least one dose of a coronavirus vaccine, and 42.4 million, or about 29%, were fully vaccinated.- AP
Singapore will be extending its Vaccinated Travel Lane (VTL) scheme to eight more countries from October 19, allowing travellers who are fully vaccinated against the COVID-19 to enter the city-state without having to serve quarantine, media reports quoting the civil aviation authority said on Saturday.
Fully vaccinated travellers from Canada, Denmark, France, Italy, the Netherlands, Spain, United Kingdom, and the United States will be able to enter Singapore under this arrangement from October 19- PTI
The Indian Society for Critical Care Medicine (ISCCM) on Saturday urged the central government to pre-plan setting up of fully functional critical care units with trained personnel, citing possibilities of a third wave of COVID-19.
The importance of a critical care unit in hospitals, which act as lifelines in salvaging patients from moribund conditions and the dire need for skilled and technically updated facility, can never be over emphasised, an ISCCM statement said.- PTI
Fiji will ease COVID-19 restrictions and announce its reopening for international travel after the country hit a vaccination milestone Saturday.
Changes to the country's virus restrictions would be announced on Sunday afternoon after 80% of the adult population received both doses of a COVID-19 vaccine, Prime Minister Frank Bainimarama said.
Last month officials said once the target was reached, Fiji would reopen travel for "green list" locations, including Australia, New Zealand, Japan, Canada, South Korea, Singapore and parts of the United States.-AFP
Singapore may need as much as six months to get to a "new normal" in terms of easing restrictions and people resuming their previous routines in the COVID-19 pandemic, Prime Minister Lee Hsien Loong said on October 9.
"It will take us at least three months, and perhaps as long as six months, to get there," Mr. Loong said in an address to the island nation. -Reuters
India has informed the UN that it will ramp up its production capacity as new Indian vaccines come on stream, emphasising that the supply chains of raw materials must be kept open as COVID-19 vaccines need to reach every corner of the globe.
India’s Permanent Representative to the UN Ambassador T.S. Tirumurti on October 8 said that India has provided medical related assistance and subsequently, vaccines to numerous countries all over the world.
India saw a single-day rise of 19,740 COVID-19 infections, taking the country's total tally of cases to 3,39,35,309, while the number of active cases has declined to 2,36,643, the lowest in 206 days, according to Union Health Ministry data updated on October 9.
The death toll has climbed to 4,50,375 with 248 more fatalities, the data updated at 8 am stated.
The daily rise in new coronavirus cases has been below 30,000 for 15 straight days, the ministry said.
The active cases have declined to 2,36,643 and comprise 0.70% of the total infections, the lowest since March last year. The national COVID-19 recovery rate has been recorded at 97.98%, the highest since March last year, it said. -PTI
Karnataka that had managed to extract and administer extra doses from each COVID-19 vaccine vial till July end, has again reported a wastage of 0.06%. The wastage is especially seen in Covaxin at 0.82%.
Although the State has recorded ‘negative wastage’ in Covishield thereby extracting 3,43,951 extra doses from the overall usage, as many as 46,472 doses of Covaxin have been wasted so far. With this, Covaxin wastage has been recorded at 0.82% as of October 7.
The United States will accept the use by international visitors of COVID-19 vaccines authorized by U.S. regulators or the World Health Organization, the Centers for Disease Control and Prevention said late on October 8.
A CDC spokeswoman said, "Six vaccines that are FDA authorized/approved or listed for emergency use by WHO will meet the criteria for travel to the U.S." -Reuters
Rehabilitation improved recovery in persons affected by severe COVID-19, say doctors.
Almost 50% of those who stay in a hospital or in an Intensive Care Unit for a long period of time are known to have complications for up to one year after recovery from COVID-19, said G. Balamurali, head of Spine Surgery, Kauvery Hospital and managing director, HAMSA Rehab.
The Assam government on October 8 allowed mobile theatres to resume functioning on certain conditions due to the COVID-19 pandemic, Health Minister Keshab Mahanta said.
Mobile theatre groups, which are popular in Assam, travel from place to place with actors and support staff and perform in makeshift halls. Their shows were closed since March last year when the lockdown was imposed.
Releasing the Standard Operating Procedure for mobile theatres, Mr. Mahanta said the groups would have to inform district authorities that they will follow the SOP. -PTI
Italy has decided to provide a booster shot of Pfizer and BioNTech's COVID-19 vaccine to frail people regardless of their age as well as people aged 60 and over, the health ministry said on October 8.
The booster dose would be available on condition that at least six months have passed since people completed their primary vaccination cycle, the ministry said in a statement. -Reuters
India and Hungary have agreed to recognise each other's COVID-19 vaccination certificates, the Ministry of External Affairs (MEA) said on October 8.
"Mutual recognition of Covid-19 vaccination certificates begins! India and Hungary agree to recognize each other's Covid-19 vaccination certificates. Will facilitate mobility for education, business, tourism and beyond," MEA spokesperson Arindam Bagchi said in a tweet. -PTI
A one-time assistance of Rs. 50,000 has been given to 89% applicants so far under a scheme to provide relief to Covid victims' families and the remaining will disbursed by next week following "perform or perish" warning by Chief Minister Arvind Kejriwal to officials, said a Delhi government statement on October 8.
The chief minister had recently "pulled up" the officials over slow progress in disbursal of the financial assistance, it said. -PTI
Colleges in Pune city will reopen for offline classes from October 11 with only those students who have got both doses of the COVID-19 vaccine being allowed entry, an order by the local civic body said.
The Pune Municipal Corporation order issued on October 8 said apart from students, it was mandatory for all teaching and non-teaching staff at these institutions to have got both doses of the vaccine. -PTI
The U.S. Centers for Disease Control and Prevention's panel of vaccine advisers plans to meet on October 20-21 to discuss COVID-19 vaccine boosters using Moderna and Johnson & Johnson shots, an agency spokesperson said on October 8.
The CDC's Advisory Committee on Immunization Practices will meet on Nov. 2-3 to discuss COVID-19 vaccination for children. -Reuters
The U.K. government on October 8 eased travel advisory restrictions for 51 further countries and territories, no longer advising against all but essential travel to popular holiday destinations such as the Bahamas, Seychelles and Jamaica.
The U.K. Foreign, Commonwealth and Development Office (FCDO) said the change means people will be able to travel to even more destinations with greater ease, covered by travel insurance. -PTI
People in Britain who took part in trials of COVID-19 vaccines which are yet to be approved, such as Novavax, will be offered two doses of another approved vaccine from next week, U.K. health officials said on October 8.
The Department of Health and Social Care (DHSC) said that while the U.K. recognises those who are in COVID-19 vaccine clinical trials as fully vaccinated, the majority of other countries currently do not. -PTI
The Delhi government has directed all private schools to ensure that their teaching and non-teaching staff are not allowed to attend school if they have not received the first dose of COVID-19, and treat their absence as being 'on leave', according to officials.
The Directorate of Education has asked all private schools to ensure that all teachers and school staff, including transportation staff, who have not received their jabs so far should be vaccinated by October 15, a senior DoE official said. -PTI
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