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)
A single dose of Pfizer/BioNTech’s Covid-19 vaccine reduces a person’s risk of infection by 72%, a new study has revealed. According to Public Health England (PHE), the first dose of the Pfizer/BioNTech Covid-19 vaccine "provides high levels of protection against infection and symptomatic disease.” PHE's Siren Study, which involved healthcare workers aged under 65, found that one dose of the Pfizer/BioNTech Covid-19 vaccine reduced the risk of infection by 72% after three weeks. Two doses of the vaccine reduced the risk of infection by 85%. This high level of protection also includes the B.1.1.7 coronavirus variant first identified in the UK in December. For the study, health workers were tested for Covid-19 infection every two weeks using PCR tests and twice a week with lateral flow tests. As Dr. Susan Hopkins, strategic response director at PHE, explained, "there was a lot of asymptomatic testing.” "Overall we are seeing a really strong effect to reducing any infection: asymptomatic and symptomatic," Hopkins said during a press conference held by the UK's Science Media Centre on Monday. Promising early data has also shown that people who are vaccinated and subsequently catch Covid-19 are far less likely to die of, or be hospitalized with, the virus. For example, people over the age of 80 who were infected after being vaccinated were 41% less likely to be hospitalized with the virus and 57% less likely to die of it.
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.
With reports emerging that several different COVID variants are now circulating around the world, Moderna has released a statement saying it believes its vaccine protects against at least two of the new strains. Moderna Inc said on Monday it believes its COVID-19 vaccine protects against both new variants found in Britain and South Africa. However, the American pharmaceutical and biotechnology company also said it will test a separate booster shot aimed at the South African variant after concluding the antibody response could be diminished. The company said in a press release that it found no reduction in the antibody response against the variant found in Britain. Against the South African variant, Moderna said it found a reduced response but still believed its two-dose regimen would provide protection. The emergence of new COVID variants in Britain, South Africa and Brazil has created some concern that mutations in the virus may make vaccines less effective. Moderna’s announcement will serve to alleviate some of that concern, but the proof will be in the infection numbers going forward. Moderna shares rose nearly 10% off the back of the news during Monday trading. Moderna said it plans to publish data from its tests against the variants on the website bioRxiv.
With Covid-19 vaccines now being rolled out in many countries across the world, a number of tech giants are teaming up to help facilitate the return to "normal". A coalition known as the Vaccine Credential Initiative — which boasts healthcare and tech leaders, including Microsoft, Salesforce, Oracle, Cerner, Cigna's Evernorth, and the Mayo Clinic (among others) in its ranks — wants to ensure that everyone has access to a secure, digital record of their Covid-19 vaccination. This kind of digital vaccine passport, which can be stored in people's smartphones, could be used for everything from airline travel to entering concert venues. The coalition has even considered those without smartphones. Such individuals will be given a printable QR code containing their record that can be scanned wherever they go. "Just as Covid-19 does not discriminate based on socio-economic status, we must ensure that convenient access to immunization records crosses the digital divide," Brian Anderson, chief digital health physician at non-profit research organization MITRE, a member of the coalition, said in a statement. With such vaccine passports in place, a healthy and safe return to work, school, travel and life in general can be accelerated.
The United States (US) and the United Kingdom (UK) have started national Covid-19 vaccine rollouts, as the pandemic situation in each country continues to worsen. In the United States, the first batches of Pfizer/BioNTech’s Covid-19 vaccine left a Michigan manufacturing plant on Sunday bound for 150 locations across the country. The vaccine will now be given to the most vulnerable Americans, including frontline health workers and long-term care home residents. The United States is slowly approaching the once unthinkable threshold of 300,000 Covid-related deaths. Meanwhile, the UK witnessed its first Covid vaccination last week. It was given to 90-year-old Margaret Keenan, with up to four million more expected to follow by the end of December. The UK made history earlier this month when it became the first country in the world to approve the Pfizer/BioNTech Covid-19 vaccine for use. The Covid-19 vaccine rollout in the UK comes as the capital, London, witnesses a surge in cases. As a result, London and several other areas in the south-east will this week enter the toughest coronavirus restrictions (tier 3) in an attempt to curb the spread of the virus and reduce infection numbers. The UK has ordered 40 million doses of the Pfizer/BioNTech vaccine — enough to vaccinate 20 million people — with the first 800,000 doses coming from Pfizer's facilities in Belgium to the UK this week.
Moderna Inc. says its experimental vaccine is 94.5% effective in protecting people from Covid-19. The claims are based on interim data from a late-stage clinical trial. Moderna is the second US company to announce a Covid-19 vaccine this week, following in the footsteps of Pfizer, whose own vaccine boasts a 90% efficacy rate. The Moderna announcement means that there could be at least two vaccines authorized for emergency use in the United States in December.As many as 60 million doses could be available by the end of 2020. Moderna and Pfizer’s vaccines are both built using new technology known as messenger RNA or mRNA. Both represent powerful new ways to combat the ongoing pandemic, which has to date infected 54 million people and killed 1.3 million. Both vaccines also come at a time when Covid-19 cases appear to be surging – especially in the US where new cases of the virus are now totaling more than one hundred thousand per day. Unlike Pfizer’s vaccine, Moderna’s does not need to be stored at ultra-cold temperatures, making it easier to distribute. This is particularly good news for countries like India with hot climates that would struggle to keep Pfizer’s vaccine at the required -70°C. Speaking about the firm's vaccine, Moderna President Stephen Hoge said: “Assuming we get an emergency use authorization, we'll be ready to ship through Warp Speed almost in hours. So it could start being distributed instantly.”
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.
People who have recovered from COVID-19 and gained immunity to the disease could lose it again within months, a new study from the UK suggests. According to the research by a team from King’s College London, the novel coronavirus (SARS-CoV-2) could reinfect people year after year, much like common colds. Having studied the immune responses of more than 90 patients and healthcare workers at Guy’s and St Thomas’ NHS foundation trust, the researchers found that COVID-19 antibody levels peaked about three weeks after the onset of symptoms. [Related reading: Coronavirus: Immunity levels likely to be higher than antibody tests suggest] Blood tests revealed that while 60% of COVID-19 patients displayed a “potent” antibody response at the height of their battle with the disease, this figure fell to just 17% three months later. In some cases, antibody levels became undetectable. The findings of the study have implications when it comes to developing a COVID-19 vaccine, as well as achieving greater herd immunity. The bottom line is that if antibody levels drop over time and people are able to be reinfected seasonally, a vaccine would not actually provide any long-term benefits. Speaking about the findings of the study, Dr Katie Doores, lead author from King’s College London, said: “People are producing a reasonable antibody response to the virus, but it’s waning over a short period of time and depending on how high your peak is, that determines how long the antibodies are staying around.”
With the COVID-19 pandemic still causing chaos in many countries around the world, much focus has turned to developing a vaccine to prevent the horrible respiratory disease. But how far off is a coronavirus vaccine and what’s taking so long? At present, estimates on how long it will take to develop a safe, effective coronavirus vaccine range from one year to 18 months, with some experts warning it would take even longer. The reality is that in vaccine years that is extremely fast and the likelihood is that a coronavirus vaccine will take longer. Right now, no less than 35 companies and academic institutions are racing to develop a vaccine for the new coronavirus. At least four have candidates that they are currently testing in animals. One, produced by Boston-based biotech firm Moderna, will begin human trials very soon. One of the reasons why some companies had a head start creating a vaccine is because coronaviruses have caused two other recent epidemics: the 2002-2004 severe acute respiratory syndrome (SARS) outbreak in China and Middle East respiratory syndrome (MERS) outbreak, which was first identified in Saudi Arabia in 2012. In both cases, work began on vaccines, but these were later shelved when the outbreaks were contained. Some of those vaccines are now being repurposed to help in the fight against Sars-CoV-2 (the virus that causes COVID-19). Once a COVID-19 vaccine that is safe and effective in humans has been approved, another challenge will be producing it in the vast quantities needed. In the meantime, thoroughly wash your hands regularly and follow COVID-19 advice.