Tag: AstraZeneca

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

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

Reckless to Discard AstraZeneca Vaccines, Says Prof Madhi

Professor Shabir Madhi of Wits University says that it would be reckless to simply abandon South Africa’s stock of AstraZeneca vaccine doses, even after a small trial showed it to have minimal effect against the local variant.

One million doses of AstraZeneca vaccine had been scheduled for rollout, but that plan has been put on hold after preliminary results showed that it conferred minimal effectiveness against mild-to-moderate infections by the dominant 501Y.V2 strain in South Africa. 

Madhi said that scientists needed more time to go through the data, said Madhi.

“I think it would be highly reckless for us to discard the vaccine. We paid a high price for it and so the vaccines do have a role in protecting from severe disease. I think an important feature in all the vaccines is that generally, vaccines work much better in preventing severe disease.”

There is already a closing window of opportunity, since it was recently discovered that the first batch of one million doses received from the Serum Institute of India would be expiring in April.

Madhi said that there were other options to put the vaccine to good use.
“If we’re strategic in terms of the rollout, we might still be able to get the vaccine used, not two doses per individual but at least a single dose and we could possibly follow it up then with another vaccine and a few vaccines that might come online in the next two or three months.”

In an interview with the BBC, he said that the disappointing results of the trial had not been able to show the effectiveness against severe COVID, as the sample size was too small and too young, with an average age of 31, but that it might still have a protective effect in different age groups. “There’s still some hope that the AstraZeneca vaccine might well perform as well as the Johnson & Johnson vaccine in a different age group demographic that I address of severe disease,” he said.

Source: Eyewitness News

Ramaphosa to Take Delivery of SA’s First Vaccine Doses

President Cyril Ramaphosa will take delivery of the first million doses arrives in South Africa at OR Tambo airport on Monday.

Ramaphosa will be accompanied by Deputy President David Mabuza, Health Minister Zweli Mkhize and the High Commissioner of India. After the vaccine has been received, it will be taken to cold storage for and undergo technical processing and quality testing.

Acting spokesperson for the Presidency, Tyrone Seale, said: “The arrival of the fist consignment at OR Tambo International Airport marks the start of the vaccine roll-out, which President Ramaphosa describes as the largest and most complex logistical vaccine undertaking in South Africa’s history.”

The AstraZeneca doses were produced by the Serum Institute of India, and healthcare workers will be the first to be vaccinated, with essential workers second on the list. However, the Department of Health has suggested that politicians (who are classified as essential workers) may be the first to receive the vaccine, in order to reassure the public and encourage vaccine uptake. An additional 500 000 doses are to be delivered in February.

There are fears that current vaccines are less effective against the B1.351 “South African” variant. The Novovax vaccine has been shown to have slightly less than 50% effectiveness in South African trials, due to the variant and the prevalence of HIV in the population. Johnson & Johnson’s vaccine, which is set to be produced locally by Aspen, is around 57% effective in South Africa. These are about what is achieved with annual flu vaccines, which are 40-60% effective. The AstraZeneca AZD1222 vaccine developed in concert with Oxford University have been shown to be 70% effective in clinical trials, although this was prior to the widespread emergence of COVID variants. However, it is possible to adjust vaccines to to deal with the new variants, with Dr Anthony Fauci saying that this reduced vaccine effectiveness against variants is a “wake-up call”.

The Azstra Zeneca vaccine uses a non replicating viral vector to deliver genetic information to cells, instructing them to produce the spike protein of the SARS-CoV-2 virus to train the immune system to recognise it and build immunity. It requires two doses administered four weeks apart, and unlike many other vaccines, does not require storage at extremely cold temperatures – only requiring normal refrigeration at 2° to 8°C.

Source: Eyewitness News

EU Demands AstraZeneca Vaccine Produced by UK Plants

In another twist to the EU’s seemingly never-ending vaccine procurement problems, the EU health minister has demanded that vaccine production from AstraZeneca’s UK operations be sent to EU countries to make up for the company’s shortfall at its two European plants. 

EU health commissioner Stella Kyriakides dismissed AstraZeneca’s argument that it the UK take precedence.

“We reject the logic of first come, first served,” the commissioner declared. “That may work at the neighbourhood butcher’s [shop] but not in contracts and not in our advanced purchase agreements. There’s no priority clause in the purchase agreements.”

The Anglo-Swedish company had triggered fury in Brussels when it was revealed that it would only be able to deliver 25% of the agreed vaccine doses when they received approval as expected this Friday. However, AstraZeneca assured the UK government that it would meet its commitment of supplying 2 million doses a week. UK government sources insisted that only once AstraZeneca had fulfilled its order to provide the UK with 100 million doses would its vaccine production be allowed to be released to serve other countries.

The EU meanwhile is flagging far behind, with only 2% of its adult population vaccinated compared to 10% of the UK’s. Kyriakides pointed out that in its contract with AstraZeneca, four European plants were listed as suppliers and two of those were located in the UK, and she expected them to work for EU citizens.

An AstraZeneca spokesperson said: “Each supply chain was developed with input and investment from specific countries or international organisations based on the supply agreements, including our agreement with the European commission.

“As each supply chain has been set up to meet the needs of a specific agreement, the vaccine produced from any supply chain is dedicated to the relevant countries or regions and makes use of local manufacturing wherever possible.”

Kyriakides said the argument was unacceptable, emphasising that the company had a moral duty to treat the EU similarly to the UK, adding that there was no “priority clause” that would justify UK residents benefiting first from doses made there.

Germany meanwhile has said that it is facing 10 weeks of vaccine shortage.
However, there is encouraging news as Israel reported a 92% effectiveness with the Pfizer/BioNTech vaccine outside trials. Only 31 of 163 000 Israelis caught COVID within ten days of the innoculation reaching its full strength. None were hospitalised.

Source: The Guardian

EU to Restrict AstraZeneca Exports to Tackle Vaccine Shortage

In response to AstraZeneca’s COVID vaccine production and delays, the European Union has warned that it will tighten exports of the company’s vaccine to countries outside its borders.

EU Health Commissioner Stella Kyriakides warned it would “take any action required to protect its citizens”, adding that she had requested detailed delivery schedules and a meeting next week with the company. She added that “in the future, all companies producing vaccines against Covid-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries”.

The vaccine, developed by Oxford University and the British-Swedish company AstraZeneca, is still yet to be approved in the EU but should receive it by the end of January, with distribution set to start on the 15th of February. The EU has been suffering from a number of vaccination programme setbacks, including a previous announcement last week from Pfizer that its own deliveries were being delayed in order to upgrade manufacturing capabilities at a plant in Belgium, provoking ire amongst EU politicians. Italy’s PM has resigned over handling of the pandemic.

The EU had signed a deal in August to secure 300 million doses from AstraZeneca, with an option for another 100 million. Last week, AstraZeneca had announced a slowdown in delivery due to “reduced yields at a manufacturing site within our European supply chain”. The problem is thought to be from a manufacturing plant also in Belgium, which is run by an AstraZeneca partner firm. The exact size of the shortfall is not known but some believe it to be a drop of 31 million doses, or 60% of those meant to be delivered by the end of the quarter.

Where this leaves low and middle-income countries counting on the Oxford/AstraZeneca vaccines is unclear, but it certainly will add to mounting tension between countries seeking vaccines for their populations amidst the spread of more contagious COVID variants. President Cyril Ramaphosa warned in an address to the World Economic Forum that vaccine nationalism was a growing concern and threat to global recovery. The African Union’s vaccine task team has thus far managed to secure only 270 million doses.

Source: BBC News

Questions Raised over Oxford’s Unusual Vaccine Regimen

The recent announcement of the Oxford’s and AstraZeneca’s vaccine trial being 70% effective up to 90% effective has raised some pointed questions.

The trial had two treatment arms, one receiving two full doses of the AZD1222 vaccine and a half dose plus a full dose, with the doses being administered 28 days apart. The “half dose then full dose”  treatment arm reported the 90% protection. The problem was that the trial was never meant to have such an arm. 

It was noticed that some participants were only receiving a half dose because they were experiencing fewer effects than expected such as arm pain and headache. This was subsequently corrected so that they would still receive the full dose on the second administration.

Of particular concern is that the “90% effectiveness” is based on a much smaller subset of the trial participants, with a correspondingly higher statistical uncertainty. So much so that there is statistical overlap with their lower effectiveness of 62% quoted for the two full doses. Furthermore, the participants were from the initial stages of the vaccine trial, where they were aged 18-55 and therefore have little applicability to the results of the main trial which included older age groups as well. 

The details of exactly why the half-measure doses came to be administered in the first place have not been revealed by Oxford or AstraZeneca. Meanwhile in the US, a Phase III of the trial is being rolled out with 40 000 participants, and the “half dose then full dose” regimen may be included – however, uncertainty about it and whether it isn’t a statistical fluke will have to be cleared up first.

Source: Ars Technica