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Sputnik V Vaccine

Russia’s Sputnik V Vaccine Is Safe And Effective Against Treating Covid-19 

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Russia announced this week that their Sputnik V vaccine is 91.6% effective against symptomatic Covid-19, and 100% effective against severe and moderate cases of the disease, according to an initial analysis of the vaccine’s Phase 3 trial data. 

The data has been collected from 19,866 participants; three-quarters (14,964) of them received two doses of the vaccine while a quarter (4,902) of them received a placebo. 16 cases of symptomatic Covid-19 appeared in the vaccine group 21 days after the first dose of the vaccine had been distributed. 62 cases were found in the placebo group, which led to the 91.6% efficacy conclusion. 

Serious adverse effects from the vaccine were rare, and none were considered to be directly caused by the vaccine and more so due to the individuals personal health. Pain at injection sites, flu-like symptoms, and low energy levels were among the most common side effects; much like the Pfizer and Moderna vaccines. 

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The data analysis only accounts for symptomatic cases of Covid-19, and the authors concluded that more research would need to be done to see how the vaccine impacts asymptomatic Covid-19 transmission and how long protection may last. Dr. Inna V Dolzhikova was a co-author of the study who suggested that the vaccine has “a high efficacy, immunogenicity, and a good tolerability profile in participants aged 18 or older.” 

Dolzhikova works at Russia’s Gamaleya National Research Center for Epidemiology and Microbiology, which developed the Sputnik V Vaccine. The participants in the trial were given PCR Covid-19 tests when they received the second shot and were required to take another test if they reported any symptoms of respiratory infection.

“The Sputnik V vaccine is a two-dose adenoviral vector vaccine using two different adenoviruses for each dose, with doses administered 21 days apart. With this type of vaccine, an adenovirus is altered so that it can deliver a piece of genetic material from the virus that causes Covid-19 into the body and get cells to express the spike induced on the virus and induce an immune response. It’s an approach similar to the vaccines developed by AstraZeneca and Johnson & Johnson,” according to new reports.

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The authors say by using an adenoviral vaccine, recipients may have a more powerful immune response. The other advantage of these kinds of vaccines in general is that they don’t need to be stored at extremely cold temperatures for transport. Sputnik V can be kept in any basic refrigerator, and it only costs $10 per dose. 

Dr. Julian Tang, a clinical virologist at the University of Leicester claimed that this news is “a useful addition to the published data on Covid-19 vaccine effectiveness, however, the median follow up was 48 days from the first dose, so the study cannot assess the full duration of protection yet.” 

The vaccine is being funded by the Russian Direct Investment Fund which will also be responsible for selling it globally. So far the vaccine has been approved in Russia, Belarus, Serbia, Argentina, Bolivia, Algeria, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Guinea, Tunisia, Armenia and the Palestinian territories. The vaccine has already been administered to more than 2 million people worldwide.

AstraZeneca Vaccine

UK Approves AstraZeneca-Oxford Covid-19 Vaccine 

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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. 

Moderna Vaccine

FDA Advisory Panel Officially Recommends Moderna’s Covid-19 Vaccine 

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An advisory panel working for the Food and Drug Administration voted to recommend Moderna’s Covid-19 vaccine for emergency use authorization, nearly one week after Pfizer’s vaccine was approved. The panel itself isn’t a part of the FDA, but is a crucial part in the process of a new vaccine being approved for public consumption. 

The Vaccines and Related Biological Products Advisory Committee met this Thursday and unanimously voted 20-0 in favor of the vaccine’s approval. Now the FDA will review the committee’s analysis and trial data, like they did with Pfizer, and will likely start sending out the vaccine next week throughout the nation. 

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The committee’s unanimous vote indicates that each expert on the panel believes that the scientific evidence gathered from Moderna’s clinical trials prove the benefits of the vaccine outweigh the risks for individuals 18 years or older. Dr. James Hildreth is the president and CEO of Meharry Medical College in Nashville, Tennessee and was a member of the panel who recently spoke with the press about how hopeful he was after looking through all the data.

“To go from having a sequence of a virus in January to having two vaccines available in December is a remarkable achievement.” 

The committee’s main role is to provide solid advice to the FDA for moving forward in terms of vaccine distribution. Members have obviously been quite busy the past two weeks as now two vaccines are receiving the green light to be administered to Americans starting this month. For the Pfizer and BioNTech vaccine, frontline healthcare workers and other priority groups (nursing home residents) began receiving their initial doses this Monday. 

Panel member Dr. Hayley Gans, a pediatrician at Stanford University Medical Center and professor of pediatrics, claims that with Moderna’s vaccine “the evidence that has been studied in great detail highly outweighs any of the issues we’ve seen and it really supports us being able to put the pandemic in our background, really move forward and finally provides a safe and effective way to get to herd immunity.”

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The Moderna vaccine reportedly is 94% effective in providing immunity against the coronavirus; Pfizer’s is just as effective as well. One of the biggest hurdles that healthcare workers/vaccine administers have had to deal with in terms of Pfizer’s vaccine is the fact that it has to be stored at ultra-cold temperatures beyond what standard pharmaceutical freezers typically can handle.

Moderna’s vaccine, on the other hand, can be kept at a standard freezer temperature, which would make it much easier to store and allow it to be distributed to more vaccination sites throughout the nation who may not have the technology to store Pfizer’s vaccine. 

Both of the vaccines require two separate doses; the Pfizer vaccine’s second dose must be given 21 days after the first while Moderna’s can be given 28 days later. 

These vaccines couldn’t have come at a better time, as America is currently in the worst phase of the pandemic yet. More than 17 million people have been infected with Covid-19 and over 310,000 people have died. As case numbers surpass 100,000 daily and deaths surpass 1,000, the federal government is continuing to debate whether or not to give its citizens $600 or not and is continuing to allow the states to determine what establishments remain open to curb the spread. 

While President-elect Joe Biden has made numerous policy promises in terms of curbing the spread, he won’t be taking office for another month, and as we’ve seen, a lot of damage can be done in a month.

Scientist Holding Moderna Vaccine

Moderna Applies For Emergency Use Authorization Of Covid-19 Vaccine In US And Europe

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Moderna announced today that it would be asking US and European regulators to allow emergency use authorization of its Covid-19 vaccine. The submission is a result of new study data confirming that the shots offer a very strong protection against the coronavirus. 

Moderna quickly followed Pfizer in their announcement of the development of a vaccine, which is crucial considering multiple Covid-19 vaccines will need to be made available in order for the pandemic to come to a true close. Moderna created its shot treatment with the US National Institutes of Health, and according to the company this past weekend’s data showed that the vaccine is more than 94% effective. 

Within the massive US clinical trial that Moderna performed, 196 participants became infected with Covid-19. Of that number, 185 received the placebo vaccine, while the other 11 got the real vaccine. The only individuals who got severely ill with the virus were those who received the placebo as well, proving the vaccines effectiveness. Dr. Tal Zaks, one of Moderna’s chief medical officers, recently rejoiced with the media about this amazing advancement. 

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“I allowed myself to cry for the first time, we have already, just in the trial, saved lives. Just imagine the impact then multiplied to the people who can get this vaccine.”

Moderna claims that so far they’ve only seen temporary flu-like side effects come from the vaccine, the same type of symptoms that appear after getting a regular flu shot. The safety data up until this point has already met the US Food and Drug Administrations (FDA) requirements for emergency use, the company just needed to complete its final trial testing before it could have all the necessary information for the FDA’s review. 

The European Medicines Agency, which is like Europe’s version of the FDA, will also likely be granting Moderna with emergency use authorization in the coming weeks. Before the FDA approves either vaccine from Moderna or Pfizer a panel of scientific advisers will publicly debate if there’s enough evidence to release either or both vaccines to the public. 

Pfizer and German tech partner BioNTech will present their vaccine data to the FDA on December 10th and Moderna is set to present theirs on December 17th. If approved, Moderna expects to distribute 20 million doses within the US by the end of the year. Recipients need two doses, meaning the initial rounds will go to 10 million people. 

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Pfizer projects that they’ll be able to distribute 50 million doses throughout the world in December if approved; 12.5 million of those doses are reserved for the US. If the FDA approves of either of the vaccines they will begin being shipped within 24 hours. This week a panel of experts established by the US Centers for Disease Control and Prevention will also be meeting to decide how the vaccine will be distributed throughout the country once approved. 

The first doses will likely be reserved for health care workers who are at the most risk of exposure, and then will go to higher risk groups like the elderly and immunocompromised. As the vaccine’s continue in their development and distribution, other essential workers and individuals at higher risk for infection will receive their doses first. “Higher risk” could also be determined based on location and how severe the Covid-19 outbreaks have been for certain parts of the country. 

The UK ordered 40 million doses of the Pfizer-BioNTech vaccine, however, that doesn’t mean the company’s December supply will all be going to the UK at first. Like in the US, all parts of the world will have their own plans for distribution to higher risk/healthcare workers initially. Both Moderna and Pfizer have used messenger RNA from the Covid-19 virus itself to make their vaccines, which is why these two have likely proven to be the most effective around the same time. 

As the world continues to wait to see when and how these vaccines will be distributed, continue to listen to your healthcare providers and follow all the necessary precautions to protect yourself, and your loved ones.

Coronavirus Vaccine in Bottles

First ‘Milestone’ Coronavirus Vaccine Offers 90% Protection 

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Pfizer and BioNTech described today as a “great day for science and humanity,” as they announced their vaccine for the coronavirus is the first of its kind that can prevent more than 90% of people from getting Covid-19, after a preliminary analysis. 

The vaccine itself has been tested on more than 43,500 people across six different countries without any major safety concerns emerging. The companies are now planning to apply for emergency approval to use the vaccine by the end of the year and begin to minimize the severity of the Covid-19 pandemic once and for all. 

Dr Albert Bourla, the chairman of Pfizer who worked alongside some of the scientists working on the vaccine, claimed that after the announcement was made that the vaccine was 90% effective there was not one scientist in the room that wasn’t “smiling ear to ear,” with some suggesting they could see life “returning to normal by the spring.” 

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“We are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.”

A vaccine has been seen as the best way for the world to return to a sense of normalcy and no longer need the many restrictions that we’ve all gotten used to within the past nine months. Within the past few months there have been a little over a dozen vaccines in their final stages of testing. This final stage is known as “phase 3” and is one of the most critical parts of vaccine development as that’s when it’s mass tested. 

This specific vaccine uses an experimental approach that injects part of the virus’s genetic code into the patient to “train” the immune system into learning what the virus looks like so the body can attack it. Two doses, three weeks apart, are needed. The trials took place in the US, Germany, Brazil, Argentina, South Africa and Turkey and showed  90% protection being achieved seven days after the second dose.

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Pfizer claims it will be able to supply 50 million doses of the vaccine by the end of the year and around 1.3 billion by the end of 2021. The UK will likely get 10 million doses by the end of the year with another 30 million already pre-ordered. 

This development, however, doesn’t give us a clear picture of when this pandemic will specifically end, but instead a more hopeful look into the future of 2021. Hospital staff, healthcare workers, and other prioritized populations will likely be vaccinated first as they are the most at risk for contracting and spreading the virus. Face masks and social distancing will likely be a part of our lives for quite some time until even distribution of the vaccine is achieved. ‘

Pfizer and BioNTech claim that they will have enough data by the third week of November to make a case to regulators for distribution. While that may mean it could still be months before the general public sees a vaccine hit the market, this milestone is a huge step in the right direction for a world that has been stuck inside since March.

Vaccine

Vladimir Putin Claims Russia Has Approved ‘World’s First’ Covid-19 Vaccine

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Putin announced the approval of the vaccine this Tuesday, claiming it to be the “world’s first” coronavirus treatment, however, many healthcare professionals around the world…

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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. 

AstraZeneca

U.S. Orders 300 Million Doses Of Potential AstraZeneca Covid-19 Vaccine

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The United States has recently secured 300 million doses, or one third of the world’s supply, of AstraZeneca’s experimental Covid-19 vaccine by pledging to give up to $1.2 billion for funding. Although there is no vaccine currently that has been proven to eradicate the coronavirus, world leaders all over are trying to restart their stalled economies by funding these experimental ones for distribution. 

President Donald Trump along with the U.S. Department of Health agreed to provide up to $1.2 billion to accelerate AstraZeneca’s development on the vaccine. They also wanted to ensure that they would have enough vaccines  for nearly every American; America has about 350 million residents, hence the 300 million doses. 

“This contract with AstraZeneca is a major milestone in Operation Warp Speed’s work toward a safe, effective, widely available vaccine by 2021,” U.S. Health Secretary Alex Azar said.

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The vaccine was initially referred to as ChAdOx1 nCoV-19, but has since been shortened to AZD1222, based on the vaccine’s chemical composition. It was initially developed at the University of Oxford, where an elite team of researchers and scientists have been working tirelessly on Covid-19 drug treatments and vaccines since this entire pandemic began. 

Oxford has been working on countless treatments but has been mainly focused on finding a 100% effective vaccine; they even were able to start human trials for a vaccine last month. Once the most recent version of AZD1222 was produced, British drug-maker AstraZeneca began the process of licensing the vaccine for future development. Obviously, the use of the vaccine as treatment to create immunity against the coronavirus is top priority, but until there’s a substantial amount of evidence that proves its effectiveness, it can be up to two years until we see a real vaccine hit the market. 

The deal between the US and AstraZeneca also states that when the vaccine is in its final stages of development scientists can perform a clinical trial on up to 30,000 Americans to test its effectiveness; with that amount of individuals participating it’s likely the vaccine will be relatively successful by that point. 

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In general AstraZeneca is going to try and ship out at least 400 million doses of the vaccine worldwide with its first round of distribution. Once they have a more secure means of manufacturing, that number will increase to one billion doses and so on until the whole world has access. The earliest that the company believes they could start dealing out the vaccines would be this September, in fact, they’re hoping to get 30 million people vaccinated by then.

“A Phase I/II clinical trial of AZD1222 began last month to assess safety, immunogenicity and efficacy in over 1,000 healthy volunteers aged 18 to 55 years across several trial centres in southern England. Data from the trial is expected shortly. There are currently no approved treatments or vaccines for COVID-19. Governments, drugmakers and researchers are working on around 100 programmes, and experts are predicting a safe and effective means of preventing the disease could take 12 to 18 months to develop,” according to reports.

So far only a few potential vaccines have gotten to the point of human trials, which is the most critical part of vaccine development. Other major drugmakers, like Johnson & Johnson, are also developing potential vaccines and creating deals with our world leaders to ensure that Americans have access to these treatments when they’re finally market ready. For now, only time will tell when that will be.