Germany, France, Italy and Spain have joined the list of countries to suspend use of AstraZeneca’s COVID-19 vaccine. The countries took the decision after reports have arisen of dangerous blood clots in some recipients. Meanwhile, AstraZeneca and European regulators have said there is no evidence the vaccine is to blame. The AstraZeneca shot is one of three vaccines currently in use in Europe. Nevertheless, the blood clot concerns and subsequent cessation of its use represents another setback for the EU’s vaccination drive – which has already been slow off the mark compared to similar campaigns in the United Kingdom and the United States. The EU’s drug regulatory agency has called a meeting for this week to review experts’ findings on the AstraZeneca vaccine and decide how to proceed. All this comes as much of Europe tightens restrictions on schools and businesses as Covid-19 cases surge. In Germany, the decision to halt the use of the Astrazeneca vaccine was taken following advice from the country’s vaccine regulator, the Paul Ehrlich Institute. It called for further investigation after blood clots were found in the brains of seven people who had been vaccinated. In response to the situation, Astrazeneca published a press release offering ‘reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence’.
People in France aged over 65 with existing health problems will be allowed to be given the AstraZeneca COVID-19 vaccine, after the French Government reversed its policy. When the AstraZeneca vaccine was approved for use by European Union regulators, the French Government said it should only be given to eligible people under 65 because data from trials in older age groups was limited. The AstraZeneca vaccine will now be offered to people up to the age of 74. However, the shot has been hit by a slow rollout and a lack of trust. French Health Minister Olivier Veran said Monday: "Anybody aged 50 or over who is affected by co-morbidities can get the AstraZeneca vaccine, including those between 65 and 74." The announcement has the potential to affect more than two million people. British health authorities released new data on Monday that showed the AstraZeneca vaccine reduced hospitalization from COVID-19 by more than 80%. The vaccine is widely used in the UK but has missed delivery targets in the EU. People aged 75 and over would continue to get the Pfizer and Moderna vaccines only, Veran said. Meanwhile, Germany still hasn’t cleared the AstraZeneca vaccine for over 65s. This has led to fewer people stepping up for the shot and several doses being wasted. Image courtesy of Marco Verch on Flickr, licensed under the Creative Commons Attribution 2.0 Generic (CC BY 2.0)
The World Health Organization (WHO) yesterday gave two versions of the AstraZeneca/Oxford COVID-19 vaccine the green light to be used for emergency use, listing them on its Emergency Use Listing (EUL), paving the way for them to be rolled out globally through COVAX. The vaccines are produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India. WHO’s EUL assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. “Countries with no access to vaccines to date will finally be able to start vaccinating their health workers and populations at risk, contributing to the COVAX Facility’s goal of equitable vaccine distribution,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. ‘But we must keep up the pressure to meet the needs of priority populations everywhere and facilitate global access. To do that, we need two things – a scale-up of manufacturing capacity, and developers’ early submission of their vaccines for WHO review.” Pfizer/BioNTech’s vaccine was listed for emergency use by WHO on 31 December 2020.
Last Saturday, February 6, France reported both a fall in new COVID-19 infections and in the number of patients being treated in hospital. The country registered 20,586 new confirmed COVID-19 cases, down from 22,139 the previous day and marking the third straight daily fall. Meanwhile, hospitals across the country were treating 27,369 people for the disease, down 245 from the previous day, marking the fourth consecutive daily fall. The fall in numbers comes as France continues with its COVID-19 vaccination programme, with 1.86 million people now having received their first dose. Almost a quarter of a million people (247,260) have also received their second dose. At present, France has three vaccines approved for use: Pfizer/BioNTech, Moderna and AstraZeneca, the latest to be received. The country has taken delivery of 273,600 AstraZeneca, according to the health ministry, with a second batch of 304,800 doses scheduled to be delivered this week. The initial AstraZeneca shots were prioritized for health personnel under 65, with the first injections taking place over the weekend. While the arrival of the AstraZeneca shot will help France accelerate its vaccination programme, the quantities that are expected to be delivered are likely to be less than first thought. Nevertheless, with a third approved vaccine and COVID numbers falling, pressure on the French health system is easing day by day.
British-Swedish pharmaceutical company AstraZeneca’s large-scale human COVID-19 vaccine trial has been paused after one of the participants developed an unexplained illness. A spokesperson for AstraZeneca said the pause is “routine” and occurred when the firm’s standard review process was triggered. An independent committee will now review safety data pertaining to the trial. AstraZeneca stressed that an adverse reaction was only witnessed in one study participant, and that pausing trials was a common part of the vaccine development process. No details have been released about the nature of the participant’s illness, but it has been reported that the individual is expected to recover. Right now, all trials of the joint AstraZeneca-University of Oxford developed vaccine, AZD1222, have been halted worldwide, including in the United States, UK, Brazil, South Africa, and India. AZD1222 is one of three COVID-19 vaccines in late-stage Phase 3 trials in the United States. AstraZeneca and eight other drug makers have said they will not seek approval from US government regulators for any vaccine until all data showed it was safe and effective. All of the companies, which include Johnson & Johnson, Merck & Co, GlaxoSmithKline, Novavax Inc, Sanofi and BioNTech, said “the safety and well-being of vaccinated individuals” was their top priority.
With the number of confirmed COVID-19 cases worldwide now at more than 25 million, any news involving potential vaccines is important, which is why a recent announcement from AstraZeneca Plc is exciting. The British multinational pharmaceutical and biopharmaceutical company, which has its headquarters in Cambridge, England, says it has begun to enroll 30,000 participants aged above 18 in the United States for a large-scale human trial of its COVID-19 vaccine candidate, AZD1222. The US trial will evaluate whether the vaccine can prevent COVID-19 infection or keep the illness from becoming severe, the National Institutes of Health said in a statement. It also will assess if the vaccine can reduce incidence of emergency department visits due to COVID-19. AstraZeneca says the study is being funded by the US Government and that participants will either receive two doses of either AZD1222 or a saline control (a placebo), four weeks apart. The AstraZeneca shot, which has been developed by researchers from the University of Oxford, is one of the farthest along of numerous COVID-19 vaccines in development. As well as the US trial, a final-stage test of the vaccine is underway in the United Kingdom. Preliminary results from this test could be yielded as soon as next month. Other companies that have COVID-19 vaccines in phase 3 trials include Moderna Inc. and Pfizer Inc.
A coronavirus vaccine developed by the Universality of Oxford and AstraZeneca appears safe and triggers an immune response that should protect people against infection. According to a trial of the vaccine involving 1,077 participants, the findings of which are published in The Lancet, the vaccine led to individuals making antibodies and T-cells that fight SARS-CoV-2, the new coronavirus. Within just 14 days of receiving the vaccine, participants’ T-cell levels peaked. After 28 days participants’ antibody levels peaked. Both T-cells and antibodies are crucial in the body’s immune defence of viruses, which is why any effective vaccine needs to induce both in the people who receive it. But while the findings are immensely promising, more research is needed to determine exactly how safe the vaccine is, whether it can indeed provide protection against SARS-CoV-2 and how long any protection would last. Nevertheless, the UK has already ordered 100m doses of the vaccine. Prof Andrew Pollard, from the Oxford research group, told the BBC: “We're really pleased with the results published today as we're seeing both neutralising antibodies and T-cells. “They're extremely promising and we believe the type of response that may be associated with protection. “But the key question everyone wants to know is does the vaccine work, does it offer protection... and we're in a waiting game.” The next step is for more than 10,000 people to take part in the next stage of the trial to further determine how safe the vaccine is. [Related reading: World leaders pledge billions to help develop coronavirus vaccine]