Tag: covid vaccination

Mechanism of AstraZeneca Blood Clotting Detailed in Study

Red blood cells. CC0 Creative Commons

A new study into rare cases of blood clots in the brain with low platelets seen in some patients after vaccination has been published in the New England Journal of Medicine.

The research team behind the study were the first clinicians in the UK to spot the link between the Oxford/AstraZeneca vaccine and rare cases of blood clotting along with a low platelet count, before identifying the correct diagnostic test for the syndrome. They recommended the treatment approach which avoids the use of heparin, an anticoagulant typically used to treat normal blood clots.

The researchers detailed the cases of 23 patients, who all presented with thrombosis and thrombocytopenia after receiving the AstraZeneca vaccine, and none of whom had underlying conditions which would predispose them to blood clots.

The presence of the PF4 antibody (platelet factor 4) was detected in almost all cases (21 out of 23). In rare instances, these antibodies are triggered by the blood-thinning drug heparin, a syndrome known as heparin-induced thrombocytopenia (HIT). However, HIT was ruled out because none of the patients in this study received heparin.

The investigators therefore concluded that they were seeing a heparin-independent PF4-dependent syndrome in the setting of the AstraZeneca vaccine. They cautioned that this syndrome needs to be identified quickly if present, because its treatment is very different to that of blood clots with low platelet counts.

Co-author Professor Tom Solomon commented: “Although it is a very rare side effect, this issue of clots in the brain and elsewhere combined with blood abnormalities following COVID-19 immunization is extremely important. It is critical we understand the disease mechanisms so we can provide the best treatment for patients. Here at the University we are part of a national program collecting information on such patients.”

The researchers stressed that vaccination is still the key means to end the pandemic, and everyone should continue to receive a vaccine when offered one.

Source: Medical Xpress

Journal information: Marie Scully et al. Pathologic Antibodies to Platelet Factor 4 after ChAdOx1 nCoV-19 Vaccination, New England Journal of Medicine (2021). DOI: 10.1056/NEJMoa2105385

SA’s Phase 2 Vaccination Rollout to Commence Soon

South Africa’s Health Department said that it was preparing to vaccinate 5.5 million people over the age of 60 by October.

Phase two will commence from mid-May to the end of October, and Health Minister Zweli Mkhize visited hospitals in Mitchells Plain to assess its readiness for the expanded rollout. The Health Department is aiming to vaccinate as many people before a possible third wave.

Dr Mkhize said that plans to inoculate 16 million people during phase two remained on track.

“After that, after October of course everybody else who has not been vaccinated will have to come in, starting with those who will be in congregate settings and risk and so on.”

Dr Mkhize said that all the paperwork and contracts with Johnson & Johnson and Pfizer had been concluded. However, the use of the J&J vaccine is still waiting on an ethics committee’s signoff for the South African Health Products Regulatory Authority’s (Sahpra) recommendation to allow resumption of that vaccine’s trial.

Last week, the SA trial was temporarily stopped after regulators in the US paused the J&J vaccine rollout in that country after six women developed a rare blood clot. Sahpra has now recommended a conditional lifting of the suspension, although its US counterpart is expected to take two weeks to assess the clot problem.

Dr Boitumelo Semete-Makokotlela at Saphra said that the protocol would now have to be altered and safety regulations tightened.

“The screening and monitoring of the participants, particularly those with high risks of blood clotting,” Dr Semete-Makokotlela said. “Secondly, the safe management and immediate management of any participants who may present with any vaccine-induced thrombosis.”

Source: Eyewitness News

Department of Health COVID Vaccine Rollout Phase 2 Outlined

The Department of Health’s COVID vaccine rollout has been fleshed out in a presentation, including details on how the vaccines will be distributed, and the jobs earmarked for the shots.

A presentation from the department indicates that the government has secured around 51 million vaccine doses, with 20 million from Pfizer and 30 million from Johnson & Johnson (J&J). However, it is unclear how the current pause in J&J administration in South Africa due to concerns about rare blood clots will affect immunisation schedules.

However, health minister Dr Zweli Mkhize announced that South Africa has secured a further 10 million Pfizer vaccines.

“We can now guarantee that the number of people that will be vaccinated with Pfizer has increased from 10 to 15 million,” he said.

With the 30 million of the single-dose shots from J&J, the current planned rollout will cover about 45 million South Africans.

Dr Mkhize said that both the Pfizer and J&J agreements cost around $10 (R145) per vaccine, with non-refundable clauses.

“The agreements state that down-payments that have been made in advance by the department shall not be refundable by the manufacturer to us in any circumstances. This is another onerous term that we had to settle for,” Dr Mkhize told the committee.

Meanwhile, government was sent an email from J&J, which stated that the company will not sign off the 20 million doses until they receive a letter from the Trade, Industry and Competition Minister, expressing support for the local investment that they made in Aspen Pharmacare.

“We’ve been taken aback by this, as there are clauses in the agreement that express this support and acknowledge that this production will not just be limited to South Africa and the continent, but also targeted for the global market,” said Dr Mkhize.

The department indicated that the Pfizer vaccine will likely go to major metropolitans due to its larger pack size and refrigeration requirements, while the J&J vaccine with its less stringent refrigeration needs would be allocated to rural areas.

South Africa’s Phase 2 of the vaccine rollout is planned to begin in May and run until October, with essential workers over 40 and the elderly to be targeted in the programme. This is to include a focus on old age homes and care facilities, plus identifying those with co-morbidities.

The department provided an overview of occupations covered under the vaccine rollout, to include, among others, the police, army, social and municipal workers, and faith and traditional leaders. Private sectors could include mining, retail, transport, and manufacturing.

Source: BusinessTech

Blood Clotting Concerns Resulting in Vaccination Delays

Vaccination programmes are facing increasing delays because of concerns over AstraZeneca’s very rare blood clotting incidents.

Australia and Greece are the latest governments deciding to offer young people alternatives to AstraZeneca’s vaccine. This will delay inoculation campaigns by around a month in Australia, France and Britain. Meanwhile, the World Health Organization said most countries lacked vaccines to cover health workers and others at high risk from exposure to the virus.

WHO Director-General Tedros Adhanom Ghebreyesus said high income countries had on average vaccinated one in four people whilst low income countries the figure was one in over 500.

“There remains a shocking imbalance in the distribution of vaccines,” he told a press briefing on Friday.

The WHO and GAVI vaccine alliance’s COVAX mechanism seeks to secure vaccines for poorer nations. GAVI alliance head Seth Berkley said AstraZeneca’s supply chain had in fact “picked up” when asked whether the vaccine was being shunned.

“As countries decide they are going to prioritise one vaccine or another, that may free up doses, and in so doing we will try to make sure those doses are made available without delay, if countries are willing to make that happen,” he said.

Australia doubled its orders for Pfizer after its health body recommended that people under 50 receive an alternative vaccine. Greece followed Britain’s example in recommending that people under 30 seek an alternative jab.

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

Sabine Straus, chair of the EMA’s safety committee, said that the European Medicines Agency (EMA) received reports of 169 cases of the rare brain blood clot by early April, after 34 million doses had been administered.

Most of the cases reported had occurred in women under 60.

On Friday, the EMA said that if a causal relationship is confirmed or considered likely, regulatory action will be needed to minimise risk. It is also investigating Johnson & Johnson’s (J&J) vaccine over reports of blood clots. US infectious disease expert Anthony Fauci however said there were no red flags reported for the J&J vaccine.

The AstraZeneca vaccine is the cheapest and most high-volume vaccine to date to curb the pandemic and avert damaging lockdowns, but supplies have been beset by delays.

However, new data in the EU, beset by delays, showed that the pace of vaccine deliveries was picking up. Germany said it was accelerating inoculations but needed a new lockdown as well.

“Every day in which we don’t act, we lose lives,” Lothar Wieler, president of the Robert Koch Institute, said.

Hong Kong Health Secretary Sophia Chan said the city would defer its order of the AstraZeneca vaccine this year “so as not to cause a waste when the vaccine is still in short supply globally”, adding that the government was considering buying a new, more effective type of vaccine.

All the countries recommending age limits for the AstraZeneca shot have emphasised that its benefits far outweigh the risks of catching COVID for older people. Even so, some people have been put off; in Madrid half of over 60s meant to receive the AstraZeneca vaccine turned up, a day after Spain’s recommendation that younger people get a different shot.

In France, where vaccine hesitancy is high, the top health body recommended that those over 55 who had received a first dose of the AstraZeneca shot get a new-style messenger-RNA vaccine for the second one: either the Pfizer/BioNTech one or Moderna’s.

Source: Reuters

COVID Vaccines and Vaccination Certificates Sold on Darknet

According to an article by BBC News, COVID vaccines and vaccination certificates are being widely sold on the darknet.

Prices can range from  $500 (R7500) and $750 for doses of the AstraZeneca, Sputnik, Sinopharm or Johnson & Johnson vaccines. Some even allow for emergency delivery with an overnight service. There are also fake vaccination certificates being sold for as little as $150.

Also known as the ‘dark web’, the darknet is a part of the internet that can only be accessed with specific browser tools. One such tool is Tor, a browser specially designed for anonymity.

Cyber-security company Checkpoint says that they have seen the number of adverts triple from when vaccines first become available, to 1200. The sources of the adverts appear to be the US, UK, Spain, Germany, France and Russia.

Oded Vanunu, head of product vulnerabilities research at Check Point told the BBC: “It’s imperative for people to understand that attempting to obtain a vaccine, a vaccination card or negative Covid-19 test result by unofficial means is extremely risky, as hackers are more interested in your money, information and identity for exploitation.”

Mr Vanunu also shared that,  as part of their research, his team purchased a Sinopharm vaccine dose from one of the vendors for $750, but are yet to receive it. His team believes that this particular vendor was a scammer, but others might be selling real vaccines.

Check Point is urging countries to protect their vaccine documentation by implementing a QR code system to make forgeries more difficult.

Source: BBC News

COVID Vaccination in Immunosuppressed Patients Produces Weak Response

An article by Dorry Segev, MD, PhD for MedPage Today reveals poor results for COVID vaccination in immunosuppressed patients, with concerning implications. 

Dr Segev professor of surgery and epidemiology and associate vice chair of surgery at Johns Hopkins University School of Medicine and Bloomberg School of Public Health.

Dr Segev and colleagues launched a national study of vaccine immune responses in immunosuppressed solid organ transplant recipients. Among 436 COVID-naïve participants who received their first mRNA vaccine dose, only 17% of them mounted detectable antibodies to SARS-CoV-2.  The researchers also found that those taking anti-metabolites (eg, mycophenolate or azathioprine) were less likely to develop antibody responses, with 8.75% with detectable antibody found in those taking anti-metabolites versus 41.4% in those not taking them.

“Naturally, we were disappointed to see these findings, as we were hoping to be able to tell our immunosuppressed patients that the vaccines seemed to work well for them. Given this observation, the CDC should update their new guidelines for vaccinated individuals to warn immunosuppressed people that they still may be susceptible to COVID-19 after vaccination,
Dr Segev wrote. 

The current CDC guidelines are worded in a way that suggests vaccination translates into immunity, Dr Segev pointed out, but the study demonstrates that for most transplant recipients, as well as other immunosuppressed patients that the vaccine does not automatically confer immunity. This could also be a concern for the some 37.9 million people around the world living with HIV, although the effects of achieving viral suppression with antiretroviral therapy have so far not been well investigated in relation to COVID. Vaccine trials so far have not had sufficient numbers of participants living with HIV to draw any conclusions.

Notably, their previous research did show that rates of COVID infection and mortality were not greater for immunosuppressed transplant patients. 
Dr Segev noted that there are some implications for immunosuppressed patients; firstly, that they should at the very least receive the second dose of their vaccination (the current research is only on the effects of the first dose), and secondly, immunosuppressed patients should be aware that they may not necessarily be immunised after receiving a vaccination. They should speak to their provider about an antibody test to determine if the immunisation has been achieved.

The researchers are continuing to investigate other aspects of immune response besides antibodies, such as T and B cells, and are also looking at other vulnerable populations.

Source: MedPage Today

Netherlands and Ireland Suspend AstraZeneca Vaccine Over Blood Clots

In the wake of reports from Norway of blood clots in people shortly after receiving the AstraZeneca vaccine, the Netherlands and Ireland have suspended its use.

The Dutch Health ministry on Sunday said that there was still no evidence of a direct link between the vaccine and possible adverse effects from Norway and Denmark, and there were no reported cases in the Netherlands.

“We can’t allow any doubts about the vaccine,” Dutch health minister Hugo de Jonge said. “We have to make sure everything is right, so it is wise to pause for now.”

Earlier on Sunday Ireland’s deputy chief medical officer, Dr Ronan Glynn, said that deployment of the AstraZeneca vaccine, which makes up 20% of the country’s 570 000 doses given so far, should be “temporarily deferred” with immediate effect as recommended by the country’s National Immunisation Advisory Committee (NIAC). However, he emphasised that there was no proof that blood clots had been caused by the vaccine.

The first blood clots were reported in Austria, and prompted a wave of concern, with Denmark suspending the AstraZeneca vaccine, along with the north of Italy. These latest cases in Norway resulted in three hospitalisations and one death.

The Norwegian Medicines Agency said the four people who had the AstraZeneca injection all had reduced numbers of blood platelets. It added: “People under the age of 50 who have received the AstraZeneca vaccine and feel increasingly unwell more than three days after vaccination, and who notice larger or smaller blue spots in the skin (skin haemorrhages) must consult a doctor or out-of-hours medical service as soon as possible.

“Similar incidents have been reported in other European countries, and the European Medicines Agency (EMA) is considering whether there may be an association with the coronavirus vaccines. So far, no conclusion has been reached.”

Professor Karina Butler, head of NIAC, said it was acting out of an abundance of caution but wanted a better understanding of this unanticipated cluster of “very serious” clotting events in younger people.

There were similarities to other cases reported elsewhere in Europe, she added. It was necessary to know “was there a possibility of a relationship with the vaccine, something which was rare but very serious and could have significant outcomes”, she said to Virgin Media News.

The agency did not yet know whether more blood clots were happening than expected in the population generally. “But they do seem to have clustered together at a level and in younger people – I mean less than 65 – where we wouldn’t necessarily have expected them to happen and thus the question was should we just pause until we get that information, because above all we want to maintain confidence in the vaccine programme so that people can feel that what they are getting is safe, that any serious safety signal is being thoroughly investigated,” she said. 

In a statement, Dr Glynn said: “It has not been concluded that there is any link between the Covid-19 vaccine AstraZeneca and these cases. However, acting on the precautionary principle, and pending receipt of further information, the NIAC has recommended the temporary deferral of the Covid-19 vaccine AstraZeneca vaccination programme in Ireland.”

Source: The Guardian

After Receiving Vaccine, Queen Elizabeth Encourages Others

After receiving her COVID vaccine, Queen Elizabeth encouraged those who were wary to think of others and do the same.

She and Prince Philip received their vaccine in the initial wave of vaccinations for the elderly in the UK. Prince Philip, 99,  is currently in hospital for a non-COVID related illness. There are concerns about the health of her husband Prince Philip, but the palace says that he is responding to treatment, but likely to remain in hospital for a few more days.

“Once you’ve had a vaccine you have a feeling of you know, you’re protected which I think is very important and as far as I could make out it was quite harmless,” the 94-year old monarch queen said in a video call with health officials supervising inoculations across the UK.

“It was very quick, and I’ve had lots of letters from people who have been very surprised by how easy it was to get the vaccine. And the jab – it didn’t hurt at all,” she added, likening the virus to a plague.

Earlier this week, the UK’s vaccine minister said that 11% to 15% of people were hesitant about receiving a vaccine, especially among minority groups.

“It is obviously difficult for people if they’ve never had a vaccine because they ought to think about other people other than themselves,” said the queen.

She praised the “remarkable” Britain’s rollout of the vaccination, one of the world’s fastest. Other members of the royal family including Prince Charles and his son Prince William, have been visiting vaccination centres over the last two weeks to convey their thanks to staff and volunteers for their work.

Data from Public Health England suggest that the vaccines are 80% effective in preventing serious COVID in the elderly.

Source: Reuters

Ghana Receives First Vaccines from Covax

Wednesday was a day to celebrate in Ghana as the country took delivery of the first 600 000 vaccines from the Covax inoculation scheme for poorer countries. According to the AFP, some 217 million people have been inoculated so far. 

The Covax scheme, which is led by Gavi the Vaccine Alliance, the World Health Organization and the Coalition for Epidemic Preparedness Innovations , is seeking to ensure low and middle-income countries equitably receive vaccines. head Tedros Adhanom Ghebreyesus cheered on the first delivery of the Covax vaccines with an enthusiastic tweet.

“At last!” he wrote. “A day to celebrate, but it’s just the first step.”

Healthcare experts had long been warning that global access to vaccines was necessary to put an end to the pandemic. Thus far, some 112 million people (and likely more, especially in Africa) have been infected with COVID and 2.4 million people have died from the disease. The recession has caused millions of job losses, and set back development in many areas.

The delivery of the Oxford/AstraZeneca vaccines was broadcast live on Ghanian TV, and will be administered in Ghanaian cities from Tuesday. About two billion doses are expected to be distributed this year under the Covax scheme, although it is unclear if this goal will be met, given the difficulty many advanced nations have experienced in getting vaccines. The European Union, for example, has suffered setbacks in deliveries from AstraZeneca and Pfizer. EU member nation Hungary has meanwhile decided to forge ahead with its own vaccine acquisition, ordering five million doses from Chinese firm Sinopharm, and this week began its first vaccinations.

The Ivory Coast is set to receive the next batch from Covax later this week. 

Source: Eyewitness News

Confusion Results in Vaccine Priority for ‘6.2cm’ Tall UK Man

As a result of an error at his GP surgery, a healthy man aged 32 was offered an early COVID vaccination because his height was recorded as 6.2cm – giving him a calculated Body Mass Index (BMI) of 28 000.

Liam Thorp, political editor at The Liverpool Echo’s, said he was left “really confused” after he was offered the vaccine ahead of the government’s rollout, sharing the “frankly surreal” experience in a Twitter thread.  Vaccinations are not expected to begin until later in the year for the UK’s under-50s without underlying health conditions, perhaps as soon as March.

Manchester Evening News politics and investigations editor, Jennifer Williams, replied: “Should they not have been in touch before to see how the man the size of a thumb was getting on?” And palliative care doctor Rachel Clarke said: “This, for me, is the single best tweet of the entire pandemic, Liam. And may I please commend your decency in not exploiting your remarkable BMI to jump the queue?”

Despite being “on the chunky side”, Thorp didn’t think of his himself as obese. He said he was “uneasy”, thinking that he still ought to accept the invitation for vaccination, he contacted his GP about the situation whereupon he learned of the error which resulted in his height being recorded as 6.2cm – a mixup of his height as 6ft 2in (188cm). This resulted in his bizarre BMI of 28 000.

“If I had been less stunned, I would have asked why no one was more concerned that a man of these remarkable dimensions was slithering around south Liverpool. But he was very apologetic and really nice and I think he was just relieved that I found it so funny,” recalled Thorp.

Dr Fiona Lemmens, chair of NHS Liverpool clinical commissioning group, said: “I can see the funny side of this story but also recognise there is an important issue for us to address.”

Source: The Guardian