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AstraZeneca Vaccine

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

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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.

Pfizer Covid-19 Vaccine

What You Need To Know About Pfizer’s Covid-19 Vaccine

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Pfizer and partner BioNTech made headlines this week after announcing that their Covid-19 vaccine was testing to be 90% effective; more than any other vaccine currently in a late-stage trial throughout the world. The news is still preliminary and a lot of questions are still unanswered, however, there is a decent amount of information that Pfizer and BioNTech has released in regards to their vaccine that could help ease some of those curiosities. 

In July, Pfizer and BioNTech began their late-stage clinical trial on their Covid vaccine. Like many of the trials currently occurring around the world, half the participants were given the vaccine, and the other half were given a saltwater placebo injection. Of the 44,000 individuals involved in the study only 94 have gotten sick with the coronavirus. When the board reviewed how many individuals got the vaccine versus the placebo, the results showed that the vaccine was over 90% effective. 

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The US Food and Drug Administration (FDA) said that a Covid-19 vaccine will only need to be 50% effective to be approved for emergency authorization. To make sense of the percentages, for reference, the flu vaccine fluctuates between 40% to 60% in efficiency every year. This means that it only fully protects between 40% – 60% of people who get the vaccine, however, it will likely minimize the intensity of the virus in everyone who receives it. These percentages fluctuate based on how bad the season is and how much the virus itself strengthens as time progresses. 

Pfizer and BioNTech haven’t reported any serious safety concerns as a result of their vaccine either, which is why the companies are so enthusiastic about the success of it. The chief executive of Pfizer said it could have 30-40 million doses of the vaccine before the end of 2020; that would be enough for 15-20 million people to get their initial shot and booster three weeks later.

Who will receive the initial doses is unclear, however, it’s been generally understood throughout the world that healthcare providers and other workers who are in more vulnerable positions will receive the initial rounds of the vaccine. The two companies predict they would be able to produce and distribute up to 1.3 billion doses a year, and while that may not be enough for the world’s entire population, other vaccines will likely appear during that time as well.

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Pfizer is applying for emergency authorization in the third week of November, after it submits at least two months of safety data to the FDA. Depending on how that authorization goes, higher risk populations could get vaccinated by the end of the year. 

One of the biggest open questions in regard to this vaccine is how it will impact individuals of different ages. The trial itself had participants that aged from 18 to over 65, however, as time went on they began including kids between the ages of 12 and 18 to make sure there weren’t any irregularities. So far, the companies have reported that the vaccine will likely protect everyone the same. 

In July, Pfizer received a $1.95 billion deal from the US government under Operation Warp Speed, the effort to rush a vaccine to the market, that entailed providing 100 million doses of the vaccine to US residents. While there has been some lack of clarity as to how well this deal has been able to hold, a spokesperson for Pfizer claimed on Monday that the company is a part of Operation Warp Speed. 

While this news from Pfizer and BioNTech is a huge sigh of relief, the world still has some ways to go, but we are on the right path. Continue to wear your mask and social distance every time you’re in a public setting and listen to your healthcare provider’s advice. As long as we keep abiding by the guidelines and waiting for the vaccine to be approved, this will all be over before we know it.

Vaccine Covid

Two Potential Covid-19 Vaccines Could Meet The FDA’s Authorization Guidelines By 2021

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Over 190 countries have joined the effort to create some sort of Covid-19 vaccine or drug treatment. According to the World Health Organization, of those trials 42 are being evaluated in clinical studies and 10 have already reached the late-stage of clinical testing. 

For America, however, there are only two coronavirus vaccines that could potentially meet the US Food and Drug Administration’s (FDA) Emergency Use Authorization guidelines by the end of 2020. In normal circumstances, new vaccines have to undergo a very long process to secure FDA approval for public use, however, in emergent situations the FDA can approve of a vaccine to be used; such as during a global pandemic that’s killing hundreds of thousands. 

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The Covid-19 pandemic qualifies as a “biological threat” under FDA guidelines, meaning the administration can grant emergency use authorization. Emergency Use Authorization (EUA), doesn’t mean that the FDA will just approve of the first vaccine to appear, but instead means they won’t be as stringent as they normally are when working to approve of a vaccine. 

The FDA recently claimed that it “does not expect to be able to make a favorable benefit-risk determination that would support an EUA without phase 3 data that included, among other factors, a high proportion of enrolled subjects (numbering well over 3,000 vaccine recipients) followed for serious adverse events and adverse events of special interest for at least one month after completion of the full vaccination regimen.”

The FDA would also want to see late-stage clinical data on the subjects who received the vaccine at least two months after they completed the full vaccine regimen. What will happen now is an advisory committee that consists of infectious disease experts not working for the FDA will review the two vaccine options and determine if it’s eligible for EUA. 

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Drug-makers would need to file for EUA of a Covid-19 vaccine by the end of November in order for it to have any chance at receiving FDA approval by the end of 2020. So far, Pfizer and BioNTech’s joint vaccine and Moderna’s RNA vaccine are the only two viable options to potentially receive EUA. 

Moderna’s CEO claimed in September that her company would have enough data to submit a request for EUA by November 25th, while Pfizer and BioNTech claim they’ll be receiving initial data from their Phase 3 trial this month. The only other vaccines that had a chance at receiving EUA by the end of 2020 were AstraZeneca’s and Johnson & Johnson’s vaccine candidates, however, both vaccine trials were recently put on pause in the US due to unexplained illnesses appearing in some of the volunteers. 

Of course, the number one priority for the FDA is how safe and effective a vaccine is, this is why there’s such an emphasis on late-stage data when it comes to vaccine development. A vaccine could completely eradicate the virus it was meant to kill but still have adverse side effects months down the line that are completely unrelated to the virus. 

As of right now, however, it’s most imperative that you as an individual are making conscious choices every day to best protect yourself, and those who you are quarantined with, by always wearing a mask in public, social distancing whenever you can, washing your hands frequently, and staying home unless absolutely necessary. 

Vaccine Development

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

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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.

Covid Studies

Researchers Pressured To Focus On Sex Differences In Covid-19 Studies 

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When it comes to medical research in general, unless a disease or virus has proven to only impact one sex over the other, men and women are often grouped together in terms of how doctors experiment to catch and fight new diseases. However, this process can be quite deadly, for example in the late 1990’s a heart drug named digoxin was marketed as being effective and safe, but after a while women were noticing a higher-rate of negative side effects when compared to men who took the drug. 

After further research it was discovered that the drug was actually attributing to a higher mortality rate in women but was decreasing mortality in men. So when it comes to the Covid-19 pandemic, some experts are wondering why there isn’t more of a focus on how this virus affects the sexes differently, if at all. 

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Covid-19 seems to be impacting all demographics relatively equally, however, it’s already been thought of that men are twice as likely to die from the virus as women. That said, the main researchers around the world that are focusing on treatments for this virus are paying little to no attention to the variations in how it impacts an individual based on their biological sex. 

One study showed that only 416 of the 2,484 Covid-19 clinical trials currently occuring around the world account for sex/gender as a criteria for volunteer recruitment. When research around the malaria treatment drug hydroxychloroquine (HCQ) was saturating media timelines a few months ago, studies showed that the drug caused heart-rhythm side-effects that could be deadly. These side effects, however, were mainly occurring in women. 

There is a general recognition today that women aren’t as heavily involved in clinical trials as men. One of the known reasons for this is due to a series of birth defects and other problems resulting from fetal exposure to certain experimental drugs during clinical trials between the 1940s and 1970s. These defects created a massive ripple effect of scientists excluding women from medical trials if they’re at an age when they’re still fertile. 

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Systemic racism in general has also caused a lot of scientists to view caucasian males as the “normal” when it comes to population types, therefore however their bodies react to whatever treatment is being tested will be universal for everyone else. Back in 2001 10 different drugs were pulled from the market after it was discovered that 8 of them were posing greater health risks for women over men due to a lack of inclusion in trials. Londa Schiebinger is a history of science professor who recently discussed the importance of sex analysis in clinical trials. 

“The problem is, if you don’t do sex analysis – if males and females have very different responses – you could miss accurate data on everybody.”

Many research funding agencies now have requirements for sex analysis’ in trials. Women have different hormone types and levels than men. They also have smaller kidneys and more fat tissue which is extremely important when it comes to medical research and dosage information. When it comes to infectious diseases, such as Covid-19, women are proven to have stronger immune systems in general due to their double X chromosomes. So in the same regard, ensuring that equal parts men and women are involved in all Covid trials is imperative for measuring all types of immune responses to this unpredictable virus.

Corona Vaccine

University Of Maryland Joins In Most Advanced Covid-19 Vaccine Trial In America

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The University Of Maryland’s School of Medicine is joining 30 other US centers that have begun recruiting thousands of citizens currently living in Covid-19 hot spots throughout the country. The goal is to get as many volunteers as possible to participate in what’s being called the most advanced trial for a vaccine against Covid-19. 

The vaccine was developed by Moderna, a Massachusetts biotech company who has been working with the National Institutes of Health on a vaccine since the beginning of this pandemic; it’s among several other vaccines throughout the world that are entering into Phase 3 of development. This specific trial in the US will be the first one to run under ‘Operation Warp Speed,’ a federal program that will hopefully be able to quickly identify, make, and distribute over 300 million doses of a coronavirus vaccine whenever one does get approved. 

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The trial will use around 30,000 volunteers after initial tests showed that the vaccine is safe and effective when administered among smaller groups. Dr. Matthew Laurens is one of the lead investigators at the University of Maryland, who claims that the biggest goal is finding a cure, but initial plans are to at least slow the rapid spreading in the US. 

“We hope it stops 100% of transmissions, but if it decreases the severity of the disease, that’s important for public health. At the end of the day, if it saves lives, that’s what’s most important.”

Five of the 27 active human trials throughout the world are in phase 3 of testing. Others are closely behind in terms of development, and many other treatments and therapies that can be used to slow the spread of the virus are also undergoing human trials. Again, the biggest goal is to save lives at any means possible. 

If the Moderna vaccine shows that it can successfully prevent an individual from being infected with Covid-19, officials believe it could be approved federally for mass distribution by mid-2021. The Moderna vaccine’s main claim is that by using messenger-RNA, their vaccine will be able to give our bodies immune system a “set of instructions” on how to create antibodies to fight the coronavirus, so that if the individual is infected, their body is already equipped to fight it off. 

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Pfizer Incorporated is a German biotech company that is also about to begin human trials on a messenger RNA vaccine; like in the US this trial is set to have up to 30,000 participants to ensure accuracy. Dr. Anthony Fauci recently spoke with the media about the incessant need for a vaccine, especially in America where so many individuals and businesses are actively ignoring health and safety procedures. 

“Although face coverings, physical distancing and proper isolation and quarantine of infected individuals and contacts can help us mitigate [coronavirus] spread, we urgently need a safe and effective preventive vaccine to ultimately control this pandemic.”

Moderna claims that if they’re successful with their vaccine it will cost around $32 – $37 per dose. The trial itself will consist of researchers drawing blood from volunteers and then administering two separate doses of the Covid-19 vaccine four weeks apart. Half will receive the actual vaccine while the other half will receive a placebo. All participants are encouraged to continue to stay home, wear masks, and maintain social distancing when in public spaces. 

Participants will also have to keep a daily journal of any symptoms or side effects they may be experiencing from the vaccine. The researchers will be doing weekly check-ins with everyone, but anyone who’s showing signs of Covid-19 will be immediately tested and given proper treatment if necessary. Researchers plan to follow this group for the next two years to see how long their immunity actually lasts, so for now, like always, it’s more of a waiting game.