India made its first advance commitments for a coronavirus vaccine under development, announcing a ₹1,500 crore deal with Hyderabad’s Biological E to stockpile 300 million doses of its candidate that has shown promising signs but is currently in the last stage of clinical trials, reported Hindusthan Times on Friday . The commitment, announced by the Union health ministry on Thursday, represents the first time the government has placed an advance purchase order, which typically helps secure large volumes of doses, and has been a strategy used by countries that managed to procure doses early. “The arrangement with Biological-E is part of the wider endeavour of Government of India to encourage indigenous vaccine manufacturers by providing them support in research & development and also financial support,” the ministry said in a statement. The move comes a day after the Supreme Court pulled up the government for its vaccination policy and gave it two weeks to submit all files and notings that “reflect its thinking and the culmination” of its vaccination policy, which judges said appeared to be “arbitrary and irrational”. Also read: Increase in Covid-19 vaccine production in India to be 'game changer' beyond borders: US The criticism around the Covid-19 vaccination drive stems from an acute shortage of doses in the country, where under 19% of the 940 million eligible people have received at least one dose. The order that the government disclosed on Thursday will help India get guaranteed access to large doses of the vaccines made by Biological E once the dose is approved. The amount committed will go towards development as well as stockpiling of the doses in advance, which will help push large quantities as soon as clearances are secured. The vaccine is likely to be marketed as Corbevax, according to names previously disclosed by the company. The 300 million doses appeared to be the cumulative capacity that Biological E told the Centre it will be able to produce for the rest of 2021. Niti Aayog’s VK Paul on May 13 said the company’s 300 million doses was among the 2.16 billion doses of various vaccines that the government was expecting to be available between August and December. It was not immediately clear when the 300 million doses will begin to become available since Phase III trials were only approved in late April, and the developers – Biological E and its partner, Texas-based Baylor College of Medicine (BCM) – are yet to release data from the Phase 1/2 studies. Dr Peter Hotez, the dean of BCM’s National School of Tropical Medicine and one of the scientists involved in the development, said in an interview to an Indian TV channel last month that clinical trials have shown there will be cross-protection against a number of variants of concern. The vaccine is made using a tried-and-tested platform that is also used in the development of the Hepatitis B vaccine, which Biological E has past experience of making. In an interview to HT in January, BCM’s Maria Elena Bottazzi said that the vaccine could particularly help inoculate children. “A hepatitis vaccine platform will also help be reassuring for paediatrics use since mRNA and viral vectors have never been used in children,” she said. Bottazzi said Biological E has worked on the technology for long and the Texas-based institute transferred the technology in summer of 2020. “They were very quick not only in scaling up and reproducing (necessary biologicals) -- we now know they can make 1.2 billion doses of the protein -- but they are also very quick at doing the formulation science,” she said. Experts welcomed Thursday’s announcement. “I am just glad that the government is taking some risk now, to do advance purchase of products that might be useful. They should have done this a year ago. Knowing you have a commitment to buy and an advanced paid from the government will encourage vaccine manufacturers to ramp up production even as they do clinical trials,” said Dr Gagandeep Kang, one of country’s top vaccinologist and physician-scientist, Christian Medical College, Vellore, Tamil Nadu. “They should also look at supporting Gennova for their mRNA product,” she added. Also read: Serum gets govt nod to produce Sputnik vaccine in India A senior public health expert, who asked not to be named, however, asked Biological E to release clinical trial data. “Permission to progress to the next phase cannot be given unless you have submitted trial results of the previous phase; therefore I don’t see why the vaccine makers should hold on to the data. If results are promising put them out for other experts to scrutinise who were not a part of the trial,” said this person “How are they so sure that phase III results will be favourable; those who understand science know that earlier phases of clinical trials are about promise and the third phase is actually what determines the real performance,” the expert added.   The move comes a day after the Supreme Court pulled up the government for its vaccination policy and gave it two weeks to submit all files and notings that “reflect its thinking and the culmination” of its vaccination policy, which judges said appeared to be “arbitrary and irrational”. The criticism around the Covid-19 vaccination drive stems from an acute shortage of doses in the country, where under 19% of the 940 million eligible people have received at least one dose. The order that the government disclosed on Thursday will help India get guaranteed access to large doses of the vaccines made by Biological E once the dose is approved. The amount committed will go towards development as well as stockpiling of the doses in advance, which will help push large quantities as soon as clearances are secured. The vaccine is likely to be marketed as Corbevax, according to names previously disclosed by the company. The 300 million doses appeared to be the cumulative capacity that Biological E told the Centre it will be able to produce for the rest of 2021. Niti Aayog’s VK Paul on May 13 said the company’s 300 million doses was among the 2.16 billion doses of various vaccines that the government was expecting to be available between August and December. It was not immediately clear when the 300 million doses will begin to become available since Phase III trials were only approved in late April, and the developers – Biological E and its partner, Texas-based Baylor College of Medicine (BCM) – are yet to release data from the Phase 1/2 studies. Dr Peter Hotez, the dean of BCM’s National School of Tropical Medicine and one of the scientists involved in the development, said in an interview to an Indian TV channel last month that clinical trials have shown there will be cross-protection against a number of variants of concern. The vaccine is made using a tried-and-tested platform that is also used in the development of the Hepatitis B vaccine, which Biological E has past experience of making. In an interview to HT in January, BCM’s Maria Elena Bottazzi said that the vaccine could particularly help inoculate children. “A hepatitis vaccine platform will also help be reassuring for paediatrics use since mRNA and viral vectors have never been used in children,” she said. Bottazzi said Biological E has worked on the technology for long and the Texas-based institute transferred the technology in summer of 2020. “They were very quick not only in scaling up and reproducing (necessary biologicals) -- we now know they can make 1.2 billion doses of the protein -- but they are also very quick at doing the formulation science,” she said. Experts welcomed Thursday’s announcement. “I am just glad that the government is taking some risk now, to do advance purchase of products that might be useful. They should have done this a year ago. Knowing you have a commitment to buy and an advanced paid from the government will encourage vaccine manufacturers to ramp up production even as they do clinical trials,” said Dr Gagandeep Kang, one of country’s top vaccinologist and physician-scientist, Christian Medical College, Vellore, Tamil Nadu. “They should also look at supporting Gennova for their mRNA product,” she added. A senior public health expert, who asked not to be named, however, asked Biological E to release clinical trial data. “Permission to progress to the next phase cannot be given unless you have submitted trial results of the previous phase; therefore I don’t see why the vaccine makers should hold on to the data. If results are promising put them out for other experts to scrutinise who were not a part of the trial,” said this person “How are they so sure that phase III results will be favourable; those who understand science know that earlier phases of clinical trials are about promise and the third phase is actually what determines the real performance,” the expert added.   The move comes a day after the Supreme Court pulled up the government for its vaccination policy and gave it two weeks to submit all files and notings that “reflect its thinking and the culmination” of its vaccination policy, which judges said appeared to be “arbitrary and irrational”. The criticism around the Covid-19 vaccination drive stems from an acute shortage of doses in the country, where under 19% of the 940 million eligible people have received at least one dose. The order that the government disclosed on Thursday will help India get guaranteed access to large doses of the vaccines made by Biological E once the dose is approved. The amount committed will go towards development as well as stockpiling of the doses in advance, which will help push large quantities as soon as clearances are secured. The vaccine is likely to be marketed as Corbevax, according to names previously disclosed by the company. The 300 million doses appeared to be the cumulative capacity that Biological E told the Centre it will be able to produce for the rest of 2021. Niti Aayog’s VK Paul on May 13 said the company’s 300 million doses was among the 2.16 billion doses of various vaccines that the government was expecting to be available between August and December. It was not immediately clear when the 300 million doses will begin to become available since Phase III trials were only approved in late April, and the developers – Biological E and its partner, Texas-based Baylor College of Medicine (BCM) – are yet to release data from the Phase 1/2 studies. Dr Peter Hotez, the dean of BCM’s National School of Tropical Medicine and one of the scientists involved in the development, said in an interview to an Indian TV channel last month that clinical trials have shown there will be cross-protection against a number of variants of concern. The vaccine is made using a tried-and-tested platform that is also used in the development of the Hepatitis B vaccine, which Biological E has past experience of making. In an interview to HT in January, BCM’s Maria Elena Bottazzi said that the vaccine could particularly help inoculate children. “A hepatitis vaccine platform will also help be reassuring for paediatrics use since mRNA and viral vectors have never been used in children,” she said. Bottazzi said Biological E has worked on the technology for long and the Texas-based institute transferred the technology in summer of 2020. “They were very quick not only in scaling up and reproducing (necessary biologicals) -- we now know they can make 1.2 billion doses of the protein -- but they are also very quick at doing the formulation science,” she said. Experts welcomed Thursday’s announcement. “I am just glad that the government is taking some risk now, to do advance purchase of products that might be useful. They should have done this a year ago. Knowing you have a commitment to buy and an advanced paid from the government will encourage vaccine manufacturers to ramp up production even as they do clinical trials,” said Dr Gagandeep Kang, one of country’s top vaccinologist and physician-scientist, Christian Medical College, Vellore, Tamil Nadu. Also read: India’s recoveries exceed new cases “They should also look at supporting Gennova for their mRNA product,” she added. A senior public health expert, who asked not to be named, however, asked Biological E to release clinical trial data. “Permission to progress to the next phase cannot be given unless you have submitted trial results of the previous phase; therefore I don’t see why the vaccine makers should hold on to the data. If results are promising put them out for other experts to scrutinise who were not a part of the trial,” said this person “How are they so sure that phase III results will be favourable; those who understand science know that earlier phases of clinical trials are about promise and the third phase is actually what determines the real performance,” the expert added.

The European Union’s drug regulator will announce the conclusions of its investigation into the possible connection between AstraZeneca’s coronavirus vaccine and rare blood clots later Wednesday, including recommendations that could have far-reaching effects on the use of the shot that is key to global efforts to end the pandemic. Earlier this week, a senior official from the European Medicines Agency said there was a causal link between the AstraZeneca vaccine and the rare clots that have been seen in dozens of people worldwide, among the tens of millions who have received at least one dose of the shot. Also Read: Canada pauses AstraZeneca vaccine for under 55 Marco Cavaleri, head of health threats and vaccine strategy at the Amsterdam-based agency, said in comments to Rome’s Il Messaggero newspaper on Tuesday that “it is becoming more and more difficult to affirm that there isn’t a cause-and-effect relationship between AstraZeneca vaccines and the very rare cases of blood clots associated with a low level of platelets.” But Cavaleri acknowledged the agency hadn’t yet figured out how exactly the vaccine might be causing these rare side effects. The agency said its evaluation “has not yet reached a conclusion and the review is currently ongoing.” The EMA is particularly focused on two types of rare blood clots: one that appears in multiple blood vessels and another that occurs in a vein that drains blood from the brain. It is also evaluating reports of people who had low levels of blood platelets, which puts them at risk of severe bleeding. Also Read: UK regulator says AstraZeneca jab safe after 7 clot deaths The EMA, the World Health Organization and numerous other health authorities have said repeatedly that the AstraZeneca vaccine is safe and effective and that the protection it offers against COVID-19 outweighs the small risks of rare blood clots. As recently as last week, the EMA said “there is no evidence that would support restricting the use of this vaccine in any population” — a response to several countries doing just that — though an expert said more brain clots were being reported than would be expected. To date, most of the cases have been reported in younger women, who are more susceptible to developing such rare clots anyway, making understanding what is causing the clots potentially more difficult. “The problem is these clots are very unusual, and we don’t really know what the background rate of them is, so it’s very hard to know if the vaccine is contributing to this,” said Dr. Peter English, who formerly chaired the British Medical Association’s Public Health Medicine Committee. A full investigation would likely take months, but English said given the urgency of the continuing pandemic, regulators would likely make a quick decision. Also Read: What we know about AstraZeneca blood clot reports “It’s very likely we will see a suspension of the vaccine’s use in certain groups while they do the further investigations to give us clearer answers,” English said. In March, more than a dozen countries, mostly in Europe, suspended their use of AstraZeneca over the blood clot issue. Most restarted — some with age restrictions — after the EMA said countries should continue using the potentially life-saving vaccine. The suspensions were seen as particularly damaging for AstraZeneca because they came after repeated missteps in how the company reported data on the vaccine’s effectiveness and concerns over how well its shot worked in older people. That has led to frequently changing advice in some countries on who can take the vaccine, raising worries that AstraZeneca’s credibility could be permanently damaged, spurring more vaccine hesitancy and prolonging the pandemic. English said the back-and-forth over the AstraZeneca vaccine globally could have serious consequences. “We can’t afford not to use this vaccine if we are going to end the pandemic,” he said. That’s because the vaccine is cheaper and easier to store than many others, is critical to Europe’s immunization campaign and a pillar of the U.N.-backed program known as COVAX that aims to get vaccines to some of the world’s poorest countries. It has been endorsed for use in more than 50 countries, including by the 27-nation EU and WHO. U.S. authorities are still evaluating the vaccine. The governor of Italy’s northern Veneto region said any decision to change the guidance on AstraZeneca would cause major disruptions to immunizations — at a time when Europe is already struggling to ramp them up — and could create more confusion about the shot. “If they do like Germany, and allow Astra Zeneca only to people over 65, that would be absurd. Before it was only for people under 55. Put yourself in the place of citizens, it is hard to understand anything,” Luca Zaia told reporters on Wednesday. The latest suspension of AstraZeneca came in Spain’s Castilla y León region, where health chief Verónica Casado said Wednesday that “the principle of prudence” drove her to put a temporary hold on the vaccine that she still backed as being both effective and necessary. “If there are in fact individuals of a certain age group that could have a higher risk (of clotting) then we need to adjust its use,” Casado told Spanish public radio. “We are not questioning AstraZeneca. We need all the vaccines possible to reach the goal of 70% of the adult population.” French health authorities said they, too, were awaiting EMA’s conclusions and would follow the agency’s recommendations, especially for the 500,000 people who have received a first dose of AstraZeneca. Even officials in Asia said they were keen to hear the EMA’s decision. On Wednesday, South Korea said it would temporarily suspend the use of AstraZeneca’s vaccine in people 60 and younger. In that age group, the country is only currently vaccinating health workers and people in long-term care settings. The Korea Disease Control and Prevention Agency said it would also pause a vaccine rollout to school nurses and teachers that was to begin on Thursday, while awaiting the outcome of the EMA’s review. English, the former chair of the British drug regulator, said that even rare, serious side effects are seen with established vaccines and that policymakers often decide that bigger public health goals warrants their use, citing the polio vaccine as an example. For every million doses that are given of the oral polio vaccine, about one child is paralyzed from the live virus contained in the vaccine. On Tuesday, AstraZeneca and Oxford University, which developed the vaccine, paused a study of the shot in children while the U.K. regulator evaluates the link between the shot and rare blood clots in adults.

Prime Minister Sheikh Hasina on Monday reaffirmed that the second dose of Covid-19 vaccine will be rolled out on Thursday next (April 8) as per the schedule. She came up with the reassurance while presiding over the weekly Cabinet meeting virtually from her official residence Ganobhaban. “The Prime Minister has made it clear that the roll-out of the second dose of coronavirus vaccine will begin on April 8 as usual as per the schedule,” said Cabinet Secretary Khandker Anwarul Islam while briefing reporters after the meeting held at the Bangladesh Secretariat. The roll-out of the first jab of the covid-19 vaccine will start on April 6, he said. Also Read: 20-30 lakh more doses of Covid-19 vaccine to arrive Feb 22 The Cabinet Secretary said there will be no problem with the stock of the second dose of the vaccines as Bangladesh will get the supply of the vaccines from India within the scheduled time. The government will review on Thursday next whether the ongoing 7-day Covid-19 lockdown should be extended or not, he said. Festival allowance for FFs The Cabinet cleared a proposal for providing two festival allowances (each Tk 10,000) to the gallantry award holding freedom fighters, Tk 2,000 as the Bengali New Year allowance to gallantry award holding freedom fighters, war-wounded freedom fighters and martyred freedom fighters’ families and Tk 5,000 as the Victory Day allowance to the living freedom fighters, said the Cabinet Secretary. Now the gallantry award holding freedom fighters are not getting the two festival allowances, the Bengali New Year allowance and the Victory Day allowance, while war-wounded freedom fighters are not getting the Bengali New Year allowance and the Victory Day allowance and the martyred freedom fighter’s families are not getting the Bengali New Year allowance, he said.

Britain’s medicines regulator is urging people to continue taking the AstraZeneca coronavirus vaccine, despite revealing that seven people in the U.K. have died from rare blood clots after getting the jab. The Medicines and Healthcare Regulatory Agency, or MHRA, said it wasn't clear if the shots are causing the clots, and that its “rigorous review into the U.K. reports of rare and specific types of blood clots is ongoing.” Also Read: Dutch temporarily halt AstraZeneca shots for under-60s Though the agency said late Friday that seven people had died as a result of developing blood clots, it didn’t disclose any information about their ages or health conditions. In total, MHRA said had identified 30 cases of rare blood clot events out of 18.1 million AstraZeneca doses administered up to and including March 24. The risk associated with this type of blood clot is “very small,” it added. Also Read:What we know about AstraZeneca blood clot reports “The benefits of COVID-19 vaccine AstraZeneca in preventing COVID-19 infection and its complications continue to outweigh any risks and the public should continue to get their vaccine when invited to do so,” said Dr. June Raine, the agency’s chief executive. Concerns over the AstraZeneca vaccine has already prompted some countries including Canada, France, Germany and the Netherlands to restrict its use to older people. The U.K., which has rolled out coronavirus vaccines faster than other European nations, is particularly reliant on the AstraZeneca vaccine, which was developed by scientists at the University of Oxford. MHRA's view about the relative benefits of the vaccine is shared by the European Medicines Agency. It has said a causal link between unusual blood clots in people who have had the vaccine is “not proven, but is possible," and that the benefits of the vaccine outweigh the risks of side effects. The World Health Organization has also urged countries to continue using the jab. Also Read: Africa CDC says India vaccine woes could be 'catastrophic' Adam Finn, a professor of pediatrics at the University of Bristol, said the “extreme rarity” of the blood-clotting events in the context of the millions of jabs administered in the U.K. makes the decision facing people very straightforward. “Receiving the vaccine is by far the safest choice in terms of minimizing individual risk of serious illness or death,” he said. A more detailed look at the MHRA’s findings show that of the 30 cases, 22 related to cerebral venous sinus thrombosis, which stops blood draining from the brain properly, and eight were connected with other thrombosis events with low platelets. It said there were no reports of any blood-clotting events around the Pfizer/BioNTech vaccine, which has also been widely rolled out in the U.K.