Lancet's COV-BOOST study, based on a UK trial, looked at the safety, immune response and side-effects of seven vaccines when used as a third booster jab after 10-11 weeks.   SEVEN Covid-19 vaccines are safe and stimulate a strong immune response when given as boosters to people who have previously received a two-dose course of either Oxford-AstraZeneca or Pfizer-BioNTech, as per the first such randomised trial of boosters published in The Lancet.   So far, little data has existed on the comparative safety of Covid vaccines, and the immune responses they stimulate as a third dose. Lancet’s COV-BOOST study, based on a UK trial, looked at the safety, immune response and side-effects of seven vaccines when used as a third booster jab after 10-11 weeks.   The seven vaccines that were given as the third dose were AstraZeneca, Pfizer, Novavax, Janssen, Moderna, Valneva and Curevac. “The side effect data show all seven vaccines are safe to use as 3rd doses, with acceptable levels of inflammatory side effects like injection site pain, muscle soreness, fatigue,” Professor Saul Faust, trial lead and Director of the NIHR Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, said. But while all the seven vaccines boosted spike protein immunogenicity after two doses of AstraZeneca, in case of Pfizer, after two doses, a booster dose of Valneva was not found to be effective.   The Serum Institute has applied to the Drug Controller General of India that Covishield be allowed to be used as booster. While AstraZeneca vaccine is administered in more than 180 countries, Pfizer is available in more than 145 countries. Two doses of the vaccines, respectively, have been shown to offer 79% and 90% protection against hospitalisation and death till six months after administration, in several studies. However, the protection is known to wane over time, driving the demand for boosters, especially for the most vulnerable, and to lessen pressure on health services and mitigate the economic impact.   Professor Faust said: “It’s really encouraging that a wide range of vaccines, using different technologies, show benefits as a third dose to either AstraZeneca or Pfizer. That gives confidence and flexibility in developing booster programmes here in the UK and globally, with other factors like supply chain and logistics also in play.”   Further research is needed to determine the effectiveness of the boosters on long-term protection and immunological memory. Researchers said studies were ongoing to find effectiveness of two of the vaccines in people who had the third dose much later, after seven-eight months. The randomised Phase 2 trial involved 2,878 participants in good health, recruited at 18 UK sites between June 1 and 30, 2021, in a mixture of commuity and secondary care settings. All were 30 or older, with half of them above 70. Participants received their first doses in December 2020, or January-February 2021, and second doses at least 70 days before enrolment for the study in case of Astrazeneca and 84 days in case of Oxford.   Adverse effects after seven days and levels of antibodies after 28 days were the primary ground of the study. The other outcome studied was the T-cell immune response. While in case of AstraZeneca, antibody levels rose 1.8 times to 32.3 times depending on the booster used, in case of Pfizer, the rise was 1.3 times to 11.5 times. Significant T-cell responses were reported in several combinations. At 28 days, all booster results were similar.   Among the side-effects, fatigue, headache, and injection site pain were the most common. Of the 2,878 participants, 912 experienced a total of 1,036 “adverse events”, 24 of those severe.   The authors warned that the booster data should be interpreted with caution because these relate to immunogenicity rather than protection against disease, and the relationship between antibody levels at Day 28 and long-term protection and immunological memory is unknown.   The other limitations of the study included that due to the pandemic and the need to generate data to inform policy in September 2021, the interval between the doses varied. Several studies have shown that a longer time period between the first and second doses may improve immunogenicity, including improved antibody responses.   Also, only recruiting people over 30 year olds limits the findings, as studies have shown that the vaccines tend to provoke a stronger immune response in younger people, and higher adverse effects. Participants were also mostly white.   This study was funded by the UK Vaccine Taskforce and National Institute for Health Research. It was conducted by researchers from University Hospital Southampton NHS Foundation Trust, University of Southampton, Imperial College London, University of Oxford, NIHR Oxford Biomedical Research Centre, Oxford Vaccine Group. Researchers in the study said that policymakers should establish criteria for choosing which booster vacci nes to use, based on immunological considerations, known side-effect profiles, in-country availability, and ultimately, what level of boost is sufficient in the context of national strategic disease control objectives.   At a press briefing on Thursday, Union Health Ministry officials said that on booster doses, their priority was clear. “Complete the task of vaccinating all adults with both doses – this is the focus and strategy that will give us the best dividend at this moment of time,” Dr V K Paul, Member, Health, NITI Aayog said.   Source: The Indian Express

Bangladesh today (July 31) received 7,81,320 doses of AstraZeneca vaccine as the second consignment of the pledged three million doses of such jabs from Japan under COVAX framework. Foreign Minister Dr AK Abdul Momen received the Japan-manufactured AstraZeneca vaccine from Japanese ambassador to Bangladesh Naoki Ito at Hazrat Shahjalal International Airport (HSIA) after a freight of ANA carrying the jabs landed in the capital around 3 pm this afternoon. Health Minister Zahid Maleque and Senior Secretary of Health Service Division Lokman Hossain Miah were also present at the airport. After receiving the vaccine, the foreign minister expressed his gratitude to the Japan government for the supply and said that Tokyo will send more than three million doses of AstraZeneca vaccine in phases. These consignments of vaccines are important for Bangladesh as around 1.5 million people are waiting for the second dose of this Oxford made vaccine, he added. Japan will send around 30.5 lakh doses of AstraZeneca vaccine, while the third consignment of these Jabs will arrive in Dhaka from Japan on August 3, Dr Momen said. On Friday, Bangladesh Ambassador to Japan Shahabuddin Ahmed saw off the second consignment of the vaccine at the Narita airport near Tokyo, according to the Bangladesh Embassy in Tokyo. On July 24, Bangladesh received 2,45,200 doses of Astra Zeneca vaccine as the first consignment from Japan under the COVAX facilities. COVAX, a global alliance, is a worldwide initiative aimed at equitable access to Covid-19 vaccines directed by Gavi, the Vaccine Alliance. Bangladesh has so far received 1.2 crore doses of AstraZeneca vaccine from the Serum Institute of India (SII). Earlier, Foreign Minister Dr AK Abdul Momen said the government has already made a good lineup of getting more COVID-19 vaccines from different sources under COVAX along with commercial purchase to ensure steady supply of jabs for the countrymen. Source: BSS AH

The United States will send up to 60 million doses of the AstraZeneca Covid-19 vaccine abroad, officials announced Monday, as President Joe Biden pledged to “be there” for India in its hour of need. Critics have accused Washington of “hoarding” the British-developed vaccine, which is not authorized in the country and will likely not be required to vaccinate Americans. The issue has risen to the fore in recent days as India faces a catastrophic new surge that has overwhelmed its health care system and driven crematoriums to full capacity. “U.S. to release 60 million Astra Zeneca doses to other countries as they become available,” tweeted Andy Slavitt, senior advisor to the White House on Covid response. An administration official told reporters the first 10 million doses could be available “in the coming weeks” after they pass a quality inspection by the Food and Drug Administration. “Further, there’s an estimated additional 50 million doses that are in various stages of production, and these could be completed in stages across May and June,” she added. White House spokeswoman Jen Psaki said at a briefing that the recipient countries have not yet been decided and that the administration was still formulating its distribution plan. But India appears to be a leading contender after Biden held a telephone call with his counterpart Prime Minister Narendra Modi, pledging US support to fight the Covid surge. “Today, I spoke with Prime Minister @narendramodi and pledged America’s full support to provide emergency assistance and resources in the fight against COVID-19. India was there for us, and we will be there for them,” Biden tweeted. Administration officials added Washington was looking at options to supply oxygen — from direct shipments to generation systems — as well as the antiviral drug remdesivir, personal protective equipment, tests, and teams of experts. – Covid cases declining – The vaccine announcement greatly expands a US action from last month to loan four million AstraZeneca doses to Mexico and Canada. It also comes as US domestic supply appears increasingly assured, making it unlikely AstraZeneca will be required. Pfizer and Moderna say they are on track to deliver 600 million doses between them by the end of July. Both are two-dose regimens. The country has also resumed vaccinations with the Johnson & Johnson single shot, the third authorized injection, after a brief pause over suspected links to a rare form of clotting. More than 53 percent of adults in the United States have so far received at least one dose of vaccine, according to official data, and domestic demand has begun to taper off as many people who wished to get vaccinated have already done so. The rate of new daily Covid cases in the United States is also in decline, dipping below a seven-day average of 60,000 for the first time in a month. Ashish Jha, dean of Brown University’s School of Public Health, said one of the main hurdles to sending AstraZeneca doses abroad had been the issue of legal liability, since the original contract was formulated between the company and the United States. “There may be some adverse events and there may even be events that are not related to the vaccine,” Jha said during a webinar, adding the maker was worried about being sued without the indemnity it enjoyed in the United States. “These are solvable in my mind by India, offering indemnity and protection to AstraZeneca,” he added. But he predicted the issue might be politically sensitive in India if the AstraZeneca vaccine comes to be viewed as a second-tier or “discarded” shot. Source: AFP/BSS AH

The World Health Organization said Friday there was no reason to stop using AstraZeneca’s Covid-19 jab after several countries suspended rollout over blood clot fears, while the hard-hit United States exceeded 100 million doses of vaccine administered to its people. The WHO, which said its vaccines advisory committee was examining the safety data coming in, stressed that no causal link has been established between the AstraZeneca vaccines and clotting. “Yes, we should continue using the AstraZeneca vaccine,” WHO spokeswoman Margaret Harris added, stressing that any concerns over safety must be investigated. UK-based AstraZeneca insisted its jab was safe, adding there is “no evidence” of higher blood clot risks. – New lockdown in Italy – Despite hopes that vaccines will pave the way to a return to normality, hard-hit Italy announced tough new restrictions in much of the country, with Prime Minister Mario Draghi warning the country faced “a new wave” of infections. One year after it became the first European country to face a major outbreak, Italy is again struggling with the rapid spread of Covid-19, this time fuelled by new, more contagious variants. Schools, restaurants, shops and museums were ordered to close across most regions of Italy, including Rome and Milan from next week. Greek authorities spoke of a “serious epidemiological situation” and warned of a third wave as infections mount in Athens and other major towns. Health experts there warned that restriction measures in place, including school closures in major conurbations, would be extended again. Disneyland Paris, one of Europe’s biggest tourist attractions, said it will not be able to reopen as planned on April 2 as infections remain stubbornly high in France. – Another possible side effect – The shadow cast over the AstraZeneca jab is adding to the European Union’s problems distributing vaccines. Denmark, Norway and Iceland paused use of the drugmaker’s shot as a precaution after isolated reports of recipients developing blood clots. Italy and Austria have banned the use of jabs from separate batches of AstraZeneca, and Thailand and Bulgaria said this week they would delay rollout. In Spain at least five regions said they had suspended use of AstraZeneca vaccines from the suspect batch banned by Austria as a precautionary measure. But several other countries, including Australia, said they would continue their rollouts as they had found no reason to alter course. Canada also said there was no evidence the jab causes adverse reactions. In a fresh hit, the EU’s drug regulator said severe allergies should be added to the possible side effects of the AstraZeneca vaccine after some likely links were found in Britain. – ‘Secret contracts’ – Austria’s Chancellor Sebastian Kurz suggested some European countries may have signed “secret contracts” with vaccine companies to receive more doses than they were entitled to based on EU rules. EU members have agreed that vaccines should be distributed among countries based on population size, but Kurz said that after comparing the total procurement figures of member states, it became clear that “deliveries do not follow the per capita quota system”. Despite setbacks elsewhere, US President Joe Biden offered hope to his country, which has battled the largest outbreak in the world. He vowed a return to some kind of normality by July 4, marking the national holiday as his target for “independence” from the virus. After a shaky start, the US has ramped up its vaccination programme, following the advice of scientists who say jabs are the only way out of a pandemic that has killed 2.6 million people around the world. The Centers for Disease Control and Prevention said 100 million vaccine doses have been administered in the US, around 30 percent of the world’s total of shots in arms so far. There was also encouraging news as the WHO approved Johnson & Johnson’s Covid-19 vaccine, paving the way for an additional 500 million doses to enter the Covax global vaccine-sharing scheme. “Every new, safe and effective tool against Covid-19 is another step closer to controlling the pandemic,” said WHO chief Tedros Adhanom Ghebreyesus. The news comes after the single-dose jab won approval from the European Union on Thursday. It has also received the green light from regulators in the United States, Canada, South Africa and France — which on Friday topped 90,000 coronavirus fatalities. Meanwhile it was announced that India will manufacture at least one billion more Covid-19 vaccine doses by the end of next year in a joint initiative with the United States, Japan and Australia. Following the nations’ first four-way summit, Biden’s national security advisor, Jake Sullivan, said the so-called Quad had made a “massive joint commitment” to vaccines. “The Quad committed to delivering up to one billion doses to ASEAN, the Indo-Pacific and beyond by the end of 2022,” Sullivan said. Source: AFP/BSS AH