German Scientists Claim They Can Improve Covid Vaccines To Further Prevent Blood Clots 

A team of scientists in Germany believe that they have figured out why an increased number of individuals have experienced blood clots after receiving the AstraZeneca and Johnson & Johnson Covid-19 vaccines. 

The scientists also believe that they can tell the manufacturers how to improve the vaccine itself to avoid clots. Rolf Marschalek, a professor at Goethe university in Frankfurt, and colleagues spoke with the media recently about their discovery. 

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“The key is in the adenovirus – the common cold virus that is used to deliver the spike protein of the coronavirus into the body. The mRNA vaccines developed by Pfizer/BioNTech and Moderna do not use this delivery system and there have been no blood clotting cases linked to them.”

The blood clots have been very rare, as with any vaccine, however, many parents are concerned about the younger age groups receiving their vaccines as there’s already less of a chance that they’ll develop severe Covid illness, but an increased risk that they would experience a blood clot. 

Currently the UK is offering vaccines to anyone under the age of 40 wherever vaccines are available. There have been 309 blood clotting cases in the UK out of 33 million people given the AstraZeneca vaccine. The scientists in a preprint analysis claim that they believe the “problem lies in the entry of the adenovirus into the nucleus of the cell rather than just the cellular fluid, where the virus normally makes proteins.” 

“The adenovirus life cycle includes the infection of cells entry of the adenoviral DNA into the nucleus, and subsequently gene transcription by the host transcription machinery. Here lies the problem: the viral piece of DNA is not optimised to be transcribed inside of the nucleus.”

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Inside of the cell’s nucleus, parts of the spike protein splice, or split apart. These sliced pieces can then become mutant protein pieces that free float throughout your body, and lead to an increased risk of blood clots; although it’s extremely rare that that will occur. 

Professor Marschalek claims that Johnson & Johnson are already in discussions with him, as he’s only continued to emphasize that “the vaccines can be redesigned to avoid the problem.” 

“Johnson & Johnson is trying to optimize its vaccine now. With the data we have in our hands we can tell the companies how to mutate these sequences, coding for the spike protein in a way that prevents unintended splice reactions.”

No word on whether or not AstraZeneca has been contacted or not, and the research presented still needs to go through a peer review in order for it to gain more national credibility throughout the United Kingdom.

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European Union Sues AstraZeneca Over Vaccine Delivery Delays 

The European Union (EU) announced this week that it will be launching legal action against the British-Swedish pharmaceutical company AstraZeneca after claims that it repeatedly under-delivered on its Covid-19 vaccine shipments throughout the continent. 

The 27 nations within the European Union have all reported a relatively slow rollout of vaccinations for citizens due to delays in delivery from AstraZeneca. The union claims that tens of millions of doses have fallen through, and the company has barely upheld their end of the contract with the EU to get every citizen vaccinated. 

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The EU initially ordered 300 million doses of the AstraZeneca Covid-19 vaccine, with an optional 100 million doses, of which the union has gone without. 

AstraZeneca released a statement in which they claimed that they “regret” that the European Commission is choosing to take action against the company, but it would be strongly defending itself in a court setting. 

AstraZeneca and the EU in general have already been dealing with some major tensions as many citizens refused to get vaccinated, so that combined with the company’s own failures to deliver the agreed upon doses has led to a major feud between the government and pharmaceutical company. 

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Stefan De Keersmaecker, health spokesperson of the European Commission, was the one who initially announced that a lawsuit had been launched, arguing that “the terms of the EU-AstraZeneca contract had not been respected, and the company has not been in a position to come up with a reliable strategy to ensure timely delivery of doses.”

“We want to make sure that there is a speedy delivery of a sufficient number of doses that European citizens are entitled to, and which have been promised on the basis of the contract. All 27 countries support this legal action.”

AstraZeneca released their own statement this Monday: “Following an unprecedented year of scientific discovery, very complex negotiations, and manufacturing challenges, our company is about to deliver almost 50 million doses to European countries by the end of April, in line with our forecast.”

The company added that “AstraZeneca has fully complied with the Advance Purchase Agreement with the European Commission and will strongly defend itself in court. We believe any litigation is without merit and we welcome this opportunity to resolve this dispute as soon as possible.”

AstraZeneca Vaccine

AstraZeneca Vaccine 79% Effective Against Symptomatic Covid-19, According To New US Study

AstraZeneca’s Covid-19 vaccine has proven to have a 79% efficacy against symptomatic Covid-19, and 100% efficacy against severe disease and hospitalizations, according to a new US study.

The findings from a new Phase 3 trial included more than 32,000 participants and came after many European nations began delaying the distribution of the AstraZeneca vaccine over blood clot fears. Many doctors and healthcare experts were quick to warn against delaying the distribution of these vaccines, because the blood clot risks were just as high as any other vaccine, and the delays are preventing vulnerable parties from being protected against the virus.

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“The trial showed that the vaccine was well-tolerated and identified no safety concerns. An independent committee found no increased risk of thrombosis (blood clots) or events characterized by thrombosis among the 21,583 participants receiving at least one dose of the vaccine,” AstraZeneca said in a statement.

Ruud Dobber is the president of AstraZeneca’s biophermaceutical’s business unit who recently spoke with the media about the company’s future plans for rolling out their vaccine in the US.

“We plan to apply for emergency use authorization from the US FDA in April. If approved we’ll be the fourth Covid-19 vaccine available in the US.”

The University of Oxford, which helped develop the vaccine, claims that the “new findings add to previous trial data from the United Kingdom, Brazil, and South Africa, as well as real-world impact data from the United Kingdom.” 79% of trial participants were White, 22% were Hispanic, 8% were Black, 4% were Native American and 4% were Asian.

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“About 20% of participants were 65 years and over and approximately 60% had conditions linked with higher risk of severe Covid-19, such as diabetes, severe obesity or heart disease. In patients 65 years and older, vaccine efficacy was 80%, — echoing the overall trial results — which is notable as some countries initially did not authorize the vaccine for use in this older age group, citing a lack of data from earlier trials,” AstraZeneca said.

“It is clear this vaccine has very good efficacy, remember that 60% was, prior to any trials being started, regarded as a good target, and that this efficacy does not show a notable decline at older ages. Previous assertions that the vaccine may be ineffective in older ages are totally unjustifiable,” according to Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine.

Dr. Peter Hotez, dean for the National School for Tropical Medicine at the Baylor College of Medicine, spoke with the press about how this new data was great news for Americans and the rest of the world: “I’m pretty confident now AstraZeneca will apply for, request emergency use authorization, so we’ll have that vaccine released to the American public. Despite recent pauses in the vaccine’s rollout, this is one of our workhorse vaccines that we’re expecting for Africa and Latin America. So this is good news also because it’s reaffirming for the vaccines used for global health as well.”

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Doctors ‘Disappointed And Confused’ That Some Countries Are Suspending Use Of AstraZeneca Vaccine

Health experts in Europe say they’re feeling “disappointed and confused” by the slew of suspicions that the AstraZeneca Covid-19 vaccine can lead to blood clots. Doctors are claiming that there’s not enough evidence for these countries to be raising these suspicions, and going so far as to suspend the use of the vaccine from the University of Oxford, especially considering a lot of European countries are still moving slowly in their vaccine distribution.  

Sweden and Latvia announced this week that they would be joining the growing number of European nations now suspending the use of the vaccine as a “precautionary measure” following reports of blood clots. Germany, France, Italy, and Spain also announced that they would cease administering the shot. 

Thailand also joined Europe in their removal of the AstraZeneca vaccine from its lineup. The UK, Canada, and Australia, on the other hand, are still distributing the vaccine, and are working to reassure their citizens that it is indeed safe, or else it wouldn’t have gotten the approval for its distribution in the first place. 

“The World Health Organization, Europe’s drug regulator and the International Society, have all recommended that countries continue to use the Oxford-AstraZeneca vaccine. The decisions by France, Germany and other countries look baffling, the data we have suggests that numbers of adverse events related to blood clots are the same (and possibly, in fact lower) in vaccinated groups compared to unvaccinated populations,” said Dr. Michael Head, senior research fellow in Global Health at the University of Southampton, U.K.

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“Halting a vaccine roll out during a pandemic has consequences. This results in delays in protecting people, and the potential for increased vaccine hesitancy, as a result of people who have seen the headlines and understandably become concerned. There are no signs yet of any data that really justify these decisions,” he added.

The WHO is meeting this week to review the safety of the shot to really give citizens that additional reassurance. The European Medicines Agency is doing the same thing, but has also already claimed that there is “no indication that the AStraZeneca vaccine is causing blood clots, the vaccine’s benefits continue to outweigh the risks.”

AstraZeneca themselves have claimed 17 million people have now received a full dose of their vaccine, and of those individuals there have been 15 reported incidents of deep vein thrombosis and 22 events of pulmonary embolism across the EU. 

“This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. The data available so far showed that the number of blood clots in vaccinated people is no higher than that seen among the general population,”  AstraZeneca said.

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Dr. Stephen Griffin is an associate professor in the School of Medicine at the University of Leeds, who recently spoke to the media about how disappointed he was that so many nations were using this fear as a reason to delay vaccine distribution. 

“Since many European countries are currently experiencing another resurgence of SARS-CoV2 infections and yet are lagging behind in terms of roll out, the importance of continuing the vaccination programs cannot be underestimated, and the harm caused by depriving people of access to a vaccine will likely vastly outweigh even the worst case scenario if any link to the clotting disorders is eventually found. It should also be noted that nationwide gestures such as this are bound to fuel hesitancy, or more extreme anti-vaccine sentiment, further undermining the vaccination effort,” Griffin proclaimed. 

“Blood clots can occur naturally and are not uncommon. More than 11 million doses of the AZ vaccine have now been administered across the UK, and the number of blood clots reported after having the vaccine is not greater than the number that would have occurred naturally in the vaccinated population,” he continued.

“We are working closely with international counterparts in understanding the global safety experience of COVID-19 vaccines and on the rapid sharing of safety data and reports. People should still go and get their COVID-19 vaccine when asked to do so,” Griffin reassured, guaranteeing European citizens that by the end of the week these major medical groups will likely re-release more updated data regarding the safety of this vaccine. 

Covid-19 Variants Causing Scientists To Rethink Vaccine Strategy

Top vaccine scientists throughout the world have made it known that current Covid-19 vaccine rollout programs need to be reexamined after variants of the virus are proving to be more resistant.

Doctor Holding Coronavirus Vaccine Syringe

Covid-19 Vaccine Delays Are Hindering Europe’s Pandemic Recovery

Health officials in Europe are threatening legal action against the two vaccine makers as a means of introducing export controls on doses.

AstraZeneca Vaccine

UK Approves AstraZeneca-Oxford Covid-19 Vaccine 

Health officials in the United Kingdom have officially authorized the AstraZeneca-Oxford University Covid-19 vaccine for distribution. The vaccine was approved this Wednesday, and marks the second vaccine in the UK approved for public distribution. 

The government is expected to begin rolling out the vaccine on Monday. The AstraZeneca-Oxford vaccine is much more inexpensive and easier to store when compared to the Pfizer and Moderna vaccines that have been approved in the US. The UK ordered 100 million doses of AstraZeneca’s vaccine which will be enough to vaccinate 50 million citizens; which equates to about three-quarters of the country’s population. 

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The government has already given out its initial doses for the Pfizer-BioNTech vaccine to over 600,000 UK residents. UK Secretary of State for Health and Social Care, Matt Hancock, spoke with the media on Wednesday as well, claiming that between the two vaccines, the government should be able to fully protect the entire population. 

The approval of this second vaccine couldn’t have come at a better time for the country, as the UK is currently battling one of the worst waves of the coronavirus since the beginning of the pandemic. With a new Covid-19 strain spreading rapidly around the UK as well, it’s expected that millions of residents will be placed under strict new lockdown measures soon; the vaccines protect against the new strain, however, the new strain is proving to give patients a much more severe case of Covid-19, so minimizing the spread is top priority.

England just recently reported a new single-day record of new Covid-19 cases with 53,000 new cases appearing on Wednesday alone; likely due to the new strain that scientists are claiming is harder to control and more transmissible than the standard coronavirus we’ve been battling all year. However, Prime Minister Boris Johnson spoke to the press this week to hopefully ease some nerves and reinforce that the second vaccine’s approval is an amazing step for the nation.

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“The second vaccine’s approval is truly fantastic news. We now just have to move to vaccinate as many people as quickly as possible.”

The AstraZeneca-Oxford vaccine is like the Pfizer and Moderna vaccine in the sense that it will require two doses to be truly effective. For this specific vaccine the second dose is required to be given 12 weeks after the first; for comparison both Pfizer and Moderna’s two doses are administered within 30 days of one another. 

AstraZeneca’s CEO, Pascal Soriot, released a statement this week in which he claimed that the vaccine “has been shown to be effective, well-tolerated, simple to administer, and is supplied by AstraZeneca at no profit.” 

Trials have shown that the AstraZeneca vaccine has a 62% effectiveness, which may be staggering for those who have seen Pfizer and Moderna’s vaccines have a 95% effectiveness, however, in all of the cases that appeared during the trial, none were serious, and even after individuals received just half of the two doses of the vaccine it still proved to be 90% effective against the coronavirus. The vaccine is expected to reach millions of residents next week once it begins distribution. 

AstraZeneca Vaccine

Oxford-AstraZeneca Covid-19 Vaccine 70% Effective, On Average 

Pharmaceutical company AstraZeneca announced on Monday that interim analysis of their Covid-19 vaccine showed it having an average efficacy of 70% in protecting the body from contracting the virus. The news comes shortly after Pfizer and Moderna announced their late-stage clinical trial results that showed both their vaccines testing at a 90-95% efficacy. 

A Covid-19 vaccine could very much bring an end to the coronavirus pandemic for the world. So far the virus has infected over 59 million people and killed 1.4 million people.

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The AstraZeneca vaccine was developed in collaboration with the University of Oxford, and was tested in two different dosage regimens. One of the dosing regimens showed the vaccine as testing at 90% effective when participants only received half of a dose, followed by a full dose one month later. The other regime showed a 62% efficacy when participants were given two full doses one month apart. 

This means the average effectiveness of the AstraZeneca vaccine is initially 70%, although no hospitalizations or severe cases of the virus appeared during the trial. Professor Andrew Pollard is the chief investigator for the Oxford Vaccine Trial and recently released a statement regarding this accomplishment. 

“These findings show that we have an effective vaccine and excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply.”

More than 23,000 volunteers participated in the trials for AstraZeneca and while a majority of the participants were based in the UK and Brazil, the University of Oxford claims more international data should be available in the coming weeks. That initial analysis could sway the actual efficacy of the vaccine, however, it’s not likely. 

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“This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency.”

Pascal Soriot is the CEO of AstraZeneca an recently spoke with the press about this “important milestone” in the fight against Covid-19. “The vaccine’s simple supply chain and our non-profit pledge and commitment to broad, equitable and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval.”

AstraZeneca also claimed it would be immediately preparing their data submission to send out to various health authorities around the world. This way organizations like the CDC and FDA can have a basic framework to work with for when the vaccine is actually ready for distribution. One of the biggest perks of this vaccine is that it can be stored much easier than the Moderna and Pfizer vaccine. 

“I think there’s also one very important advantage of the AstraZeneca-Oxford vaccine, the ease to use it at refrigerator temperature I think is a very important element of our vaccine so that also, patients and people in low-income countries and middle-income countries can benefit,” said  executive vice president of AstraZeneca’s biopharmaceuticals business unit, Ruud Dobber.

AstraZeneca claims its vaccine can be stored, transported, and handled at normal refrigerated conditions; between 36-46 degrees Fahrenheit.

Vaccine Development

Johnson & Johnson Pause Covid-19 Vaccine Trial Due To Unexplained Illness Appearing 

Johnson & Johnson have become the latest to put their Covid-19 vaccine trial on pause due to an unexplained illness appearing in one of the participants. AstraZeneca and the University of Oxford also made headlines recently when they had to pause their trial for the same reason. The AstraZeneca trial, however, has resumed in Canada and Europe, just not the US. 

For Johnson & Johnson, however, a document was recently sent out to outside researchers who were running the clinical trial – which involved 60,000 patients – that claimed a “pausing rule” had been met and the trial was to stop immediately until a proper investigation into the sick individual has been performed. 

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The online system that’s been used to enroll patients in the study has been officially closed and all data that’s already been collected from various committees would be collected and analyzed together. Johnson & Johnson recently spoke with the media about putting their trial on pause but provided little information based on the fact that they themselves are still working on the investigation. 

“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”

Johnson & Johnson did emphasize in their statement that adverse events like this happening during a clinical study for a vaccine made for a virus the world knows so little about, is normal. In fact, the AstraZeneca trial has had to pause a few times now due to unexplained illnesses appearing in certain participants. These issues that cause the trials to come to a halt are typically isolated incidents and have to do with the individuals personal health over anything else. 

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They also emphasized the difference between a “study pause” and a “clinical hold” when it comes to vaccine trials. A clinical hold is a formal regulatory action that can cause a vaccine trial to stop for a long-time. This incident, however, falls more under the study pause category, as the company is projecting to restart the trial this week. 

Late Monday evening the data and safety monitoring board, or DSMB, for the Johnson & Johnson trial met to review the case involving this sick participant. When it comes to these illnesses it’s not always immediately clear what the cause is, but the first thing the first thing the DSMB needs to determine is if the patient received a version of the vaccine, or a placebo. 

The fact that this trial is one of the biggest in the world also means that these pauses are likely to occur more than once. Again, AstraZeneca has had to take multiple pauses and their trial involves about half the participants as Johnson & Johnson. A source recently spoke with the media about how common these pauses are.

“If we do a study of 60,000 people, that is a small village. In a small village there are a lot of medical events that happen.” 

Johnson & Johnson initially began enrolling volunteers for Phase 3 of their clinical trial for a Covid-19 vaccine on September 23rd. Researchers initially planned on enrolling 60,000 participants from all over the world and are planning to still hit that number as well.

Doctor with Covid-19 Vaccine

AstraZeneca Covid-19 Vaccine Being Reviewed For Approval In Canada And Europe 

U.K.-based drugmaker AstraZeneca has long been leading the race in developing a vaccine to fight off Covid-19. The company partnered with the University of Oxford in the beginning of the pandemic to begin preliminary research on ways to treat and destroy the virus. However, within the last four weeks the team has fallen behind on their trial operations.

AstraZeneca made the announcement in September that they would be temporarily pausing its late-stage clinical studies for the Covid-19 vaccine in the US, Europe and Canada due to participants getting infected with the virus itself. Now, the company has since resumed its trials in multiple countries and is already being reviewed for potential regulatory approvals in Canada and Europe. 

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However, trial operations within the US have slowed tremendously, leaving the nation way behind in its development. Initially, the trial’s were paused after a participant in the U.K. developed an unexplained illness after receiving the experimental vaccine. This pause in trial is rather routine, as most vaccine and drug trials need to do a full investigation when unexplained results appear; like the illness the participant in the U.K. experiences. 

AstraZeneca was obviously transparent in the beginning of this trial that unexpected illnesses and other side effects were to be expected in any sort of medical trial, and luckily the incident with the participant in the U.K. ended up being as routine as any other side effect to appear during a trial; hence the restarting of trials in Europe and Canada. 

Regulators in Brazil, India, South Africa, and Japan have reviewed the findings from AstraZeneca’s trial, and have allowed late-stages clinical trials to resume. This is also occurring in Canada and Europe, however, the U.S. Food and Drug Administration (FDA) still hasn’t allowed the company to resume their clinical trial.

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AstraZeneca recently claimed that they were working closely with the FDA to provide all the information needed in order for the administration to resume the trial. The FDA has since widened their investigation and are now looking at data from clinical trials regarding similar vaccines developed by the same scientists working on the Covid-19 treatment. 

This process is to determine if similar side effects that occured to the patient in the U.K occured in other vaccine trials developed by the same individuals; it is still unknown how long this data analysis will actually take. However, the agency is under immense pressure from the government to resume the trial process as the election gets closer and closer. 

Back in May the U.S. government agreed to pay over $1.2 billion for AstraZeneca to supply 300 million doses of their Covid-19 vaccine to the nation. The company won’t be able to send those doses, however, until the FDA gives emergency use authorization, which won’t happen until the trials are able to fully resume. 

For now, residents of the U.S. will have to wait to see how long it takes for the FDA to complete their investigation and restart the trial process to get a vaccine on the streets as soon as possible.