Tag: AstraZeneca vaccine

AstraZeneca-Oxford nasal vaccine for COVID-19 performs poorly in clinical trials

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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AstraZeneca and Oxford University’s COVID-19 vaccine to be administered as a nasal spray has seen disappointing results during its first clinical trials. Due to poor performance, the scientists may be looking to scrap the nasal spray and change the drug to be delivered through other systems like nebulisers. The results of the trial were published in the journal eBioMedicine.

“The nasal spray did not perform as well in this study as we had hoped. The delivery of vaccines to the nose and lungs remains a promising approach, but this study suggests there are likely to be challenged in making nasal sprays a reliable option,” explained Dr Sandy Douglas, the chief investigator for the clinical trial.

The trial involved 30 individuals not previously vaccinated against COVID-19 and 12 more individuals who had taken both doses of the COVID-19 vaccine. While the nasal spray had no safety concerns, the scientists found that there was a lack of strong systemic response in the body as well as a “weak and inconsistent” immune response. The scientists also found that the number of antibodies after two doses was lower than comparative levels in individuals who received the normal vaccines. But in most cases, there was barely any detectable antibody level.

“Reactogenicity (safety response) was acceptable at all doses but immunogenicity (immune response) was insufficient to warrant further development of the current formulation/device combination,” the scientists noted.

Scientists have been looking to develop a nasal vaccine against COVID-19 as they would be far easier to administer and can possibly stop the spread of the virus completely due to their administration route. Apart from the AstraZeneca formulation, there are at least 10 other nasal vaccines that are currently in various pre-published trials. One among these is Hyderabad-based Bharat Biotech International’s iNCOVACC, which received restricted approval from Central Drugs Standard Control Organisation (CDSCO) in adults last month.

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AstraZeneca vaccine as third dose effective against Omicron: Study

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The AstraZeneca Vaxzevaria vaccine showed an increased antibody response to the Omicron variant of COVID-19 after a third booster dose, preliminary data released by the Anglo-Swedish biopharma major said on Thursday.

In an ongoing safety and immunogenicity trial of the vaccine, a formulation developed by Oxford University and administered in India as Covishield, it was found that giving it as a third dose increased the body’s immune response to Beta, Delta, Alpha, and Gamma SARS-CoV-2 variants.

A separate analysis of samples from the trial showed an increased antibody response to the Omicron variant. The results were observed among individuals previously vaccinated with either Vaxzevria or an mRNA vaccine. The company said it is submitting this additional data to health authorities around the world given the urgent need for third dose boosters.

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WHO chief discusses Covaxin, resumption of AstraZeneca vaccine supplies to COVAX facility with Mandaviya

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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WHO chief Tedros Adhanom Ghebreyesus discussed the issue of the emergency use listing of Bharat Biotech’s COVID-19 vaccine Covaxin and resumption of supplies of the Serum Institute of India-manufactured AstraZeneca vaccine to the COVAX facility among other topics during a telephonic conversation with Health Minister Mansukh Mandaviya.

Had a call with @mansukhmandviya, India’s Health Minister, to discuss #India’s ongoing #COVID19 vaccination programme; the need for a global pandemic agreement; digital health; & traditional medicine. We welcome India’s support to strengthen WHO, incl. via flexible, sustainable financing, Ghebreyesus tweeted on Tuesday.

The WHO Director-General said that he also discussed with Mandaviya vaccine equity issues: the resumption of SII/AstraZeneca vaccine supplies to #COVAX; the Covaxin Emergency Use Listing process; and technology and license sharing through C-TAP. COVID-19 Technology Access Pool (C-TAP) was launched in May last year for facilitating timely, equitable and affordable access of COVID-19 health products by boosting their supply.

Mandaviya had also tweeted that he had a detailed interaction with the WHO chief, accompanied by other senior officials of the global health agency on various issues related to health, including pandemic management and WHO reforms. DG WHO lauded the mammoth efforts undertaken by the Indian government for #COVID19 vaccination, Mandaviya tweeted.

The cumulative number of Covid vaccine doses administered in India crossed 99 crore on Tuesday and as the country is close to administering 100 crore doses. According to official figures, around 74.45 per cent of India’s eligible adult population has been administered at least one dose of the Covid vaccine and around 30.63 per cent have received both doses. On Monday, WHO said it is expecting one additional piece of information from Bharat Biotech regarding its COVID-19 vaccine COVAXIN and emphasised that it has to thoroughly evaluate to ensure vaccines are safe and cannot cut corners before recommending a vaccine for emergency use.

We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the #COVID19 Emergency Use Listing, but we cannot cut corners – before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective, the global health organisation had said in a tweet. Bharat Biotech – the manufacturer of Covaxin – has been submitting data to WHO on a rolling basis and WHO experts have reviewed these data. WHO is expecting one additional piece of information from the company today, it said.

WHO said the timeframe for its Emergency Use Listing procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for the WHO to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries. When the information provided addresses all questions raised, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation whether to grant Emergency Use Listing to the vaccine, it said.

On Sunday, World Health Organisation Chief Scientist Soumya Swaminathan had said in a tweet that the technical advisory group at the World Health Organisation will meet on October 26 to consider the Emergency Use Listing for Covaxin. Bharat Biotech had submitted EOI (Expression of Interest) on April 19 for its vaccine. The WHO said it began rolling data of the vaccine on July 6. Rolling data allows the WHO to start its review right away, as information continues to come in, to accelerate the overall review process.

According to the WHO, submissions to the global health body for prequalification or listing under the emergency use procedure are confidential. If a product submitted for assessment is found to meet the criteria for listing, WHO will publish the results widely. Duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on those data meeting WHO criteria, according to the agency.

Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India. The Covishield vaccine, which has been developed by AstraZeneca, is manufactured in India by Pune-based Serum Institute of India. India will resume export of surplus COVID-19 vaccines in the fourth quarter of 2021 under the Vaccine Maitri’ programme and to meet its commitment to the COVAX global pool.

The government had stopped export of COVID-19 vaccines after the second wave of the pandemic hit the country in April this year. India has exported over 66 million vaccine doses to nearly 100 countries through grants, commercial shipments and the COVAX facility.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

AstraZeneca Covid vaccine linked to rare neurological disorder in India, UK

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Eleven people who received the AstraZeneca-Oxford COVID-19 vaccine have developed a rare neurological disorder called Guillain-Barre syndrome, clinicians in India and England have reported in two separate studies.

While seven cases were reported from a medical centre in Kerala, where about 1.2 million people were administered the AstraZeneca COVID-19 vaccine, known as Covishield in India, four were reported from Nottingham, UK, in an area in which approximately 700,000 (7 lakh) people received the jab.

All 11 had received the Covid preventive 10-22 days earlier. In Guillain-Barre syndrome (GBS), the body’s immune system mistakenly attacks part of its peripheral nervous system –the network of nerves located outside of the brain and spinal cord.

The two studies, published in the journal Annals of Neurology on June 10, describe an unusual variant of GBR characterised by prominent facial weakness. The frequency of GBS from the areas where the cases were reported was estimated to be up to 10 times greater than expected, the authors of the two studies said.

As of April 22, 2021, around 1.5 million individuals in three districts of Kerala, had been vaccinated with COVID-19 vaccines, the researchers noted, adding that over 80 per cent of these individuals (1.2 million) received the AstraZeneca preventive. In this population, during the period from mid-March to mid-April 2021, the researchers from Aster Medcity, Kochi, and Indo-American Brain and Spine Center, Vaikom, Kerala, observed seven cases of GBS that occurred within two weeks of the first dose of vaccination.

All seven patients developed severe GBS, the researchers said. The frequency of GBS was 1.4 to 10-fold higher than that expected in this period for a population of this magnitude, they said.

The frequency of facial weakness on both sides of the face, which typically occurs in less than 20 per cent of GBS cases, suggests a pattern associated with the vaccination, according to the research authors. While SARS-CoV-2 vaccines are very safe, we report four cases of the bifacial weakness with paraesthesias variant of GBS occurring within three weeks of vaccination with the Oxford-AstraZeneca SARS-CoV-2 vaccine, said the authors of the UK study from Nottingham University Hospitals NHS Trust.

We suggest vigilance for cases of bifacial weakness with paraesthesias variant GBS following vaccination for SARS-CoV-2 and that post-vaccination surveillance programmes ensure robust data capture of this outcome, to assess for causality, they added. Although the benefits of vaccination substantially outweigh the risk of this relatively rare outcome (5.8 per million), the researchers noted that clinicians should be alert to this possible adverse event.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

EU to launch new legal action against AstraZeneca over delay in vaccine deliveries

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The European Commission will start on Tuesday a second legal case against AstraZeneca over its delayed deliveries of COVID-19 vaccines, a spokesman for the EU executive said on Monday.

The move is mostly procedural after a first case was launched in April, an official familiar with the case said, adding however that this new legal action will allow the EU to seek possible financial penalties.

“Tomorrow the case against AstraZeneca on the merits will be introduced before the Belgian court,” the commission’s spokesman said.

The first legal action was about requesting faster deliveries, whereas the new one will concern the merit of the case.

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Top American civil rights leader urges Biden to release 60 million doses of AstraZeneca vaccine for India

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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A top American civil rights leader has urged President Joe Biden to release 60 million AstraZeneca vaccine doses for India, which is battling a devastating second wave of the coronavirus pandemic. The AstraZeneca vaccine has not been approved by the US and is unlikely to be used by the Biden administration.

Biden had recently said that he intended to give AstraZeneca vaccines to other countries. At a news conference in Chicago, American civil rights activist Rev Jesse Jackson said he would speak to Biden to immediately release 60 million doses of AstraZeneca vaccines to India.

Mass level vaccination is said to be the only cure to the current public health crisis in India, he said. ”They are human beings. As the wind blows, if we don’t stop it today, it’ll spread around the world, he said.

Expressing concern over the current situation in India, Rev Jackson said he will personally speak to the healthcare industry to donate oxygen concentrators and cylinders to India and follow up with the pharmaceutical giants to ensure therapeutic supplies to the country. Other Indian Americans from the Chicago area echoed similar sentiments.

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”It is everyone’s duty to help India flatten this COVID-19 surge as we live in a world that cannot be separated by borders,” said Dr Vijay Prabhakar, the chairman of the American Association of Multiethnic Physicians. ”Based on the current projections some of the models are suggesting, there may be 1 million deaths by the end of August. As we know, that would be a tragic humanitarian crisis, said Dr Srinivas Reddy, the trustee of Chicago Medical Society.

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Explainer: How worried should we be about blood clots linked to AstraZeneca and J&J vaccines?

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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US regulators have recommended pausing the use of Johnson & Johnson’s COVID-19 vaccine, as they investigate rare blood clotting in six women.

J&J also said it was stopping the rollout of its vaccine in Europe.

The move comes after Europe’s drug regulator earlier this month said it had found a possible link between AstraZeneca’s COVID-19 vaccine and very rare blood clots in some adults who had received the shot.

Britain’s health regulator, meanwhile, has recommended people under the age of 30 get an alternative COVID-19 vaccine, if possible, rather than the AstraZeneca shot.

Here’s what we know so far:

WHAT HAS HAPPENED?

With both the AstraZeneca and Johnson & Johnson (J&J)vaccines, the reports involve extremely rare clotting, including a type of blood clot called cerebral venous sinus thrombosis (CVST), that were seen in combination with low levels of blood platelets, called thrombocytopenia.

A U.S. Centers for Disease Control and Prevention (CDC) committee plans to review the cases linked to the J&J vaccine, and the U.S. Food and Drug Administration (FDA) will review its analysis.

The agencies, like their European counterparts, described the clotting as extremely rare.

The European Medicines Agency (EMA) has said its vaccine side effects monitoring system, as of April 4, had received 169 reports of cases of CVST, or clots in blood vessels exiting the brain, and 53 cases of splanchnic vein thrombosis (SVT), or clotting in veins in the abdomen.

That’s out of 34 million AstraZeneca vaccine doses administered in Britain and the European Economic Area over the past three months.

The EMA’s safety committee carried out a review of 62 cases of CVST and 24 cases of SVT, of which 18 were fatal.

Most cases occurred within two weeks of the person receiving their first dose.

German vaccination officials, who recorded 29 cases of CVST in women aged 20 to 59 who received the AstraZeneca vaccine, said the occurrence rate in that group was 20 times higher within 16 days of vaccination than what would have typically been expected.

Germany’s health ministry has said 1 to 1.4 cases of CVST would have been expected during that time.

WHO EXPERIENCED THE RARE SIDE EFFECTS?

In J&J’s case, all six recipients were women between the ages of 18 and 48, and the symptoms occurred six to 13 days after vaccination. In total, more than 6.8 million doses of the Johnson & Johnson vaccine have been given in the United States through April 12.

Similarly, most of the cases reported in Europe have occurred in women under 60, though that could be misleading, since Germany and Britain say more women got AstraZeneca’s shot than men.

Most cases occurred within two weeks of people getting the first AstraZeneca dose.

WHAT HAVE THE COMPANIES SAID?

J&J said it was working closely with regulators and noted no clear causal relationship had been established between the events and its shot.

AstraZeneca said it was “working to understand individual cases and “possible mechanisms that could explain these extremely rare events”.

WHAT HAVE REGULATORS SAID?

The CDC is recommending pausing using J&J’s single-dose vaccine “out of an abundance of caution” to ensure that the health care providers are aware of potential side effects and can plan for “proper recognition and management.”

Britain’s Medicines and Healthcare products Regulatory Agency, meanwhile, made its recommendation for an alternative vaccine to AstraZeneca’s to be used for people under 30 after reviewing 79 cases of rare clotting coupled with low platelets, with 19 fatalities – 13 women and six men. Eleven of the deaths were of people under the age of 50 and three were under the age of 30.

HOW DO TREATMENT RECOMMENDATIONS DIFFER?

In the United States, health officials said treatment of the blood clots with possible ties to the J&J vaccine differs from what might be considered standard in such situations.

“Usually, an anticoagulant drug called heparin is used to treat blood clots,” they said. “In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.”

HOW DID REGULATORS COME TO THEIR DECISIONS?

In its findings, the EMA said on March 18 that, on average, just 1.35 cases of CVST might normally have been expected among people under 50 within 14 days of receiving AstraZeneca’s vaccine, whereas by the same cut-off date 12 cases had been recorded.

British officials drew on statistics from the University of Cambridge’s Winton Centre for Risk and Evidence Communication to explain their recommendations that young people get an alternative shot while older people can continue to get AstraZeneca’s.

According to the Centre, the risk of serious harm due to vaccination falls the older people get and the number of admissions to intensive care units falls sharply thanks to vaccinations, boosting the AstraZeneca shot’s benefit-to-risk ratio.

The Centre concluded that only 0.4 people for every 100,000 in the 50-59 age group would suffer vaccine-linked harm, while 95.6 ICU admissions per 100,000 people would be prevented.

WHAT’S THE EU DOING NOW?

The EMA, which said the benefits of using AstraZeneca’s vaccine continue to outweigh any risks, said that unusual blood clots with low blood platelets should be listed as very rare side effects and countries should decide on how to proceed.

These may vary from nation to nation, the EMA said, depending on factors like infection rates and whether there are vaccine alternatives.

ANY THEORIES ON CAUSE OF THE CLOTS?

Among possible causes being investigated are that the vaccine triggers an unusual antibody in rare cases. So far, risk factors like age or gender have not been singled out.

German scientists at Greifswald University concluded in a paper published last week in the New England Journal of Medicine that the extremely rare cases of clotting with low platelets – something they are calling “vaccine-induced immune thrombotic thrombocytopenia” – are triggered by antibodies found in the affected patients following vaccination with AstraZeneca’s shot.

A separate group of Norwegian scientists have made similar conclusions – that AstraZeneca’s vaccine triggered an immune response that may have led to clotting in a small number of people – in their own article, also published in the New England Journal of Medicine.

Andreas Greinacher, an Greifswald expert on drug-induced immune responses, is, like the EMA, seeking clues about why in rare cases people developed clots and low platelets after getting the vaccine, while the vast majority did not.

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AstraZeneca COVID-19 vaccine: Blood clots and risk factors

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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New scientific studies have found that the Oxford/AstraZeneca COVID-19 shot is–in rare cases–leading to serious blood clots in people vaccinated with it. The vaccine has been deployed in nearly 115 countries and following the negative reports over the past few weeks, some European countries are rethinking its use. The European Medicines Agency (EMA) — the body of the European Union in charge of the evaluation and supervision of medicinal products — has, however, repeatedly said the vaccine’s benefits far outweigh its risks.

How bad are the side effects?

The EMA has said most blood clot cases have been reported in women below 60 within two weeks of getting the shot. But it could not list specific risk factors such as age group or pre-existing health conditions.

The occurrence of this side-effect is very low, but people should still seek medical help immediately if they develop symptoms – such as shortness of breath, swelling in the leg, chest pain, persistent abdominal pain, severe headaches or blurred vision, and tiny blood spots under the skin beyond the site of injection, it added.

The British medicine regulator studied people who had developed clots after receiving the vaccine. They found some of the recipients developed a clot type called Cerebral Venous Sinus Thrombosis (CSVT), which stops blood from draining out of the brain and ultimately leads to a stroke.

Around 34 million people had been vaccinated in the EU and the UK by this date, according to EMA.

The BBC has reported that some 79 people — two-thirds of them women — in the UK had suffered rare blood clots after vaccination by the end of March. Nineteen of them were fatal. And the UK has recommended people under 30 to get an alternative vaccine if possible.

What is the stand of medical experts and the World Health Organization?

On Wednesday, experts with the World Health Organization said further studies are required to confirm the link between the AstraZeneca vaccine and rare blood clots.

Germany’s medical regulator Paul Ehrlich Institute was among the first to report this condition in mid-March. Several other countries, including the Netherlands, then temporarily suspended the use of the AstraZeneca shots for people under 60.

AstraZeneca has said its research found no causal link with blood clots.

Gagandeep Kang, an eminent virologist, and Professor at the Christian Medical College in Vellore, has said the risk associated with the vaccine is “very small” and there is absolutely no need for apprehension. She said India should have reported 320 cases of blood clot associated with administering the vaccine by now if the European levels of risk calculated for AstraZeneca were to apply to the country, News18 reported.

What about the other vaccines?

On Friday, Europe’s drug regulator said that they were also looking into reports of Johnson & Johnson’s shot over blood clots. Four cases of rare blood clots with low platelets were reported after among J&J’s vaccine recipients. However, it’s still not clear if the vaccine caused these clots.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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Spain to vaccinate sexagenarians with AstraZeneca shot

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Spain will continue vaccinating 60 to 65 year olds with AstraZeneca’s coronavirus shot before proceeding to the next priority group of 66 to 69 year olds, the Health Ministry said on Thursday.

The ministry announced on Wednesday it would limit the vaccine to people over 60 after regulators linked it to a rare form of brain blood clots.

Prior to that, Spain had been administering the drug to key workers from 18 to above 65 years old.

The ministry said it would soon decide whether to give a second dose of the shot to people who had already received a first.

The European Medicines Agency (EMA) on Wednesday said it had reports of 169 cases of the rare clotting disorder out of 34 million doses administered within Europe, roughly one for every 100,000 people under 60 vaccinated.

Most occurred in women under 60 and within two weeks of injection.

The EMA said the benefits of the shot outweighed the risks and said countries should set their own regulations, leading to a patchwork of different rules governing its use.

Cases of the virus have been increasing for several weeks in Spain, which has fully vaccinated some 3.02 million people and administered a total of 9.8 million shots.

On Thursday Spain reported 9,901 new cases, bringing the cumulative total to 3.34 million, while the death toll climbed by 142 to 76,179.

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African Union drops AstraZeneca vaccine

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The African Union’s disease control body said on Thursday it had dropped plans to secure AstraZeneca COVID-19 vaccines for its members from the Serum Institute of India, the world’s biggest vaccine supplier, amid global shortfalls of the shot.

AstraZeneca’s $3 shot is by far the cheapest coronavirus vaccine launched so far, and the easiest to store and transport, making it well suited to developing countries.

On Wednesday, European and British medicine regulators said they had found possible links between the vaccine and extremely rare cases of brain blood clots, while emphatically reaffirming its importance in mass vaccination against COVID-19.

John Nkengasong, head of the Africa Centres for Disease Control and Prevention (Africa CDC), said the AU’s decision had nothing to do with those findings, and reiterated his advice that the benefits of the vaccine outweighed the risks.

He said the main reason was to avoid duplicating COVAX’s efforts by the World Health Organization-backed COVAX facility, which will continue to supply AstraZeneca to Africa.

He said the AU was focusing on the Johnson & Johnson vaccine, citing a deal announced last week to supply Africa with up to 400 million doses.

COVAX aims to deliver 600 million shots – most of them from AstraZeneca – to some 40 African countries this year, enough to vaccinate 20% of their populations.

Africa trails most other regions in COVID-19 vaccinations; fewer than 13 million doses have been administered on a continent of 1.3 billion people, according to the Africa CDC.

‘NOT COMPETING’

The AU had wanted to secure up to 500 million additional AstraZeneca shots for its 55 member states, at $3 per shot.

However, last month India suspended its exports to meet rising domestic demand.

Nkengasong said the subsequent delays were complicating vaccination across Africa, noting that health systems had to know that second doses would be available in time for those who had received a first dose.

Matshidiso Moeti, who heads the WHO’s Africa office, confirmed the two organisations wanted to ensure they were “not competing and stepping over each other looking for the same vaccines”.

“I am very much assured that it is not to do with doubts about the safety and other considerations on the AstraZeneca vaccines. It’s simply to recognise that there are challenges with the volumes that are available,” she told a separate news briefing.

The single-shot J&J doses secured last week will not arrive until the third quarter, and Nkengasong said Africa would find it hard to bridge the gap in the meantime.

South Africa has cancelled orders of the AstraZeneca vaccine after finding it gave only minimal protection against mild-to-moderate infection caused by the country’s dominant, highly infectious variant.

Russia and China are also offering vaccines, but there are questions about their cost and availability in large volumes.

The virus is confirmed to have killed 114,000 people across Africa, and infected 4.33 million.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow