First Authorizations Of Rna Vaccines
In the United States, an Emergency Use Authorization is “a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID19 pandemic.” Once an EUA is issued by the FDA, the vaccine developer is expected to continue the Phase III clinical trial to finalize safety and efficacy data, leading to application for licensure in the United States. In mid-2020, concerns that the FDA might grant a vaccine EUA before full evidence from a Phase III clinical trial was available raised broad concerns about the potential for lowered standards in the face of political pressure. On 8 September 2020, nine leading pharmaceutical companies involved in COVID19 vaccine research signed a letter, pledging that they would submit their vaccines for emergency use authorization only after Phase III trials had demonstrated safety and efficacy.
As of December 2020, many countries and the European Union have authorized or approved the Pfizer-BioNTech COVID19 vaccine. Bahrain and the United Arab Emirates granted emergency marketing authorization for the Sinopharm BIBP vaccine. In the United Kingdom, 138,000 people had received the Pfizer-BioNTech COVID19 vaccine Comirnaty by 16 December, during the first week of the UK vaccination programme. On 18 December 2020, the US FDA granted an EUA for mRNA-1273, the Moderna vaccine. Vaccine manufacturers are awaiting full approvals to name their vaccines.
Whats Really Changing Your Dna Viruses
One of the myths floating around the internet is that COVID-19 vaccines change your DNA. As the sourdough bread example illustrates, it’s actually viruses that do that, not vaccines.
In fact, viruses can infect, and change, anything living: animals, plants, bacteria and even other viruses.
Think of them as an instruction manual. Sitting on a table, for example, outside of a living being, a virus does nothing its inert and harmless. But once it enters our nose and lungs, it uses our own living cells to put its instructions into motion.
One cell can make a million copies of a virus, says Luis Villarreal, UC Irvine professor emeritus and co-founder of The Center for Virus Research. In the case of COVID-19, the virus takes hold inside a respiratory cell, where it makes millions and millions of copies of itself, before moving on to replicate in other cells in our body.
What happens next? Either the virus keeps going until it runs out of cells to infect or the body figures out how to stop it. Vaccines help your body recognize a virus invader and defend against it.
What Are The Differences Between The Two Vaccines
Most of the U.S.-backed vaccines target the spike protein found on the surface of the virus that causes COVID-19, which allows the virus to attach itself to host cells and infect them.
Both of these vaccines work by presenting this spike protein to the immune system. The spike proteins arent dangerous because the rest of the virus isnt present however, the body now sees the protein and designs immune “soldiers” to fight it.
The Moderna and Pfizer vaccines deliver strands of genetic material known as mRNA, which turns peoples cells into spike protein factories.
This technology has never been used before in an approved vaccine, though it has been tested against other diseases. The mRNA technology was chosen this time because scientists knew it could be developed quickly.
Other COVID-19 vaccine candidates being supported by the U.S. government target the spike protein via a different carrier virus or tiny particle.
The vaccines require different types of storage.
The Pfizer/BioNTech vaccine must be kept super-cold at the temperature of dry ice until shortly before it is used. The Moderna vaccine needs to be frozen if stored for a long time, but it can be refrigerated for up to a month before being used.
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What Does It Show
PHEs SIREN study shows that healthcare workers were 72% less likely to develop infection after one dose of the vaccine, rising to 86% after the second dose.
Protection starts after two weeks. This protection will help to reduce the spread of infection, thus protecting the whole population as you cannot spread the virus if you dont have infection.
Over A Decade Of Research To Innovate Mrna As A ‘bioplatform’
One of the reasons Moderna’s mRNA Covid vaccine development moved so quickly is because scientists had been working with mRNA for years.
“Messenger RNA technologies have been in development from a basic science perspective for over 15 years,”Kizzmekia Corbet, the scientific lead for the Coronavirus Vaccines & Immunopathogenesis Team at NIH, who helped make the vaccine possible, told the NIH Record.
And Moderna has been working with mRNA technology “since its inception in 2010 for myriad therapeutic areas,” including cancer therapies, Afeyan tells CNBC Make It , and with clinical development of mRNA-based antiviral vaccines since 2015.
What Moderna did over many of those years was develop mRNA as what scientists call a bioplatform, which allows for speedier vaccine development. Bioplatforms are systems that can easily be scaled and tailored for many different diseases.
Traditionally, developing any vaccine essentially has been a bespoke effort.
“The benefits of a bioplatform is the ability to quickly redeploy the platform once established and refined in the case of Moderna’s mRNA platform, to create and test new vaccines based on new viral sequences,” Afeyan tells CNBC Make It .
All of this makes mRNA vaccines virtually programable. Corbet and Bancel describe the process as “plug and play.”
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Fda Evaluation Of Safety And Effectiveness Data For Approval For 16 Years Of Age And Older
The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.
To support the FDAs approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.
Specifically, in the FDAs review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
Ut Southwestern Medical Center
In the first week of vaccination alone, the UT Southwestern Medical Center in Dallas is supposed to receive 5,850 dosesone of the largest allotments in Texas. Unlike many institutions, UT Southwestern has enough ultra-cold freezers to handle large shipments of the Pfizer-BioNTech vaccine. Doses are set to arrive Tuesday morning, according to a hospital spokesperson.
Dr. Trish Perl, UT Southwesterns chief of infectious diseases, says the hospital prioritized employees for early vaccination based on their exposure not only to COVID-19 patients, but also to patients at risk of developing severe cases of coronavirus if infected, such as those on the geriatrics or bariatrics wards.
Each department head was asked to draw up a list of employees theyd like to get vaccinated early. For her staff, Perl submitted people likely to be on service shortly after the vaccines arrived, as well as those working in high-risk units like the COVID-19 ward. Those lists go into a big black box, and then after that I dont really know how theyre determining it, Perl says.
She says employees will likely receive messages through their electronic health records, prompting them to agree to receive the vaccine and provide certain health information. Theyll then receive a time and place for vaccination. Its not like we can just line up and get our arms jabbed, Perl says. With an emergency-use authorization, there is an informal consent process that goes on.
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University Of Pittsburgh Medical Center
At 9:15 a.m., the hospitals allotment of 975 doses of COVID-19 vaccine were delivered by UPS. By 11 a.m., five health care workers, including a surgical nurse, an ICU nurse, a transporter and an environmental services employee, were vaccinated during a live-streamed press briefing. Im in the COVID pods every day, to help clean and check stuff, so puts me at ease that I have an extra layer of protection vs. the PPE that we wear. That shot puts my mind at ease a little more, Manny Philavong, who works in environmental services at UPMC, said.
The hospital expects to administer all of its doses of the vaccine this week. The first to get the jab are those with the highest risk of exposure to infection, including those working directly with COVID-19 patients, says Tamim Minnier, chief quality officer at UPMC who is also a registered nurse and administered all five of the initial vaccinations. As with many other hospitals, UPMC is not aware of when the next shipment of vaccines will arrive. We hope over the next week or two we will be receiving additional doses, she said.
Early Polio Vaccine Projects
Unfortunately, initial trials were poorly executed and caused great harm to those involved. Teams of researchers in New York and Philadelphia both administered vaccines containing active poliovirus to tens of thousands of living subjects, including children and chimpanzees. Many subjects became severely ill or paralyzed, experienced allergic reactions, and even died of polio.
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When Was The First Vaccine Created
- Smallpox is caused by the Variola virus, which dates back to prehistoric times
- other diseases traveled around the world before effective vaccines were created.
- Edward Jenner was born in Berkeley, Gloucestershire, England, in 1749.
- the World Health Assembly announced that smallpox had been eradicated from the world.
With the race to find a COVID-19 in full swing, now is a good time to look back on history to learn about how the very first vaccines were created. To understand the timeline, we will start with one of the first natural diseases known to humans, smallpox, called the scourge of mankind.
Smallpox is caused by the Variola virus, which dates back to prehistoric times. The earliest evidence of smallpox-like skin lesions was found on Egyptian mummies from 1570 to 1085 BC. Other indications of the disease were found in ancient Asian cultures, from around 1122 BC. It was later found in Europe, the West Indies, Africa, and the New World.
Safety For Those Who Are Pregnant Lactating Or Planning A Pregnancy
Early on in the Covid vaccine rollout, there were no data on which to determine if the vaccines were safe for people who are pregnant or lactating. But after several studies, experts have concluded the vaccines are safe during pregnancy and lactationand furthermore, they are important for these two groups to receive. This study in the New England Journal of Medicine, for instance, looked at the safety of Pfizer and Moderna vaccines in pregnant and lactating people.
The CDC and the American College of Obstetricians and Gynecologists advise that people who are pregnant or lactating should get vaccinated, because of the risk Covid infection poses to them.
There are a lot of rumors making the rounds that getting vaccinated against Covid will negatively impact a persons ability to conceive a child. ESPN football reporter Allison Williams recently announced she was quitting the network which has a vaccine mandate because she wants to have another child.
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University Of Maryland Medical System
The University of Maryland Medical System purchased six ultra cold freezers and rented several more to ensure they had enough storage space for the Pfizer-BioNTech vaccines. The first batch of 975 doses arrived on Monday morning.
Senior director of pharmacy Joseph Di Cubellis, says that his team has been trained to manage the vials, which, because of the temperature requirements, must be placed back in the freezers within three minutes after they are removed if they arent going to be used. If they are going to be used, they can remain in a refrigerator for up to 120 hours.
Once vials are removed from the freezer and replaced, they cant be taken out again for another two hours. That means pharmacists need to be on top of how many vaccines they will be giving, and ensure that they defrost the right number at the right time. What happens if some people dont show for their vaccine appointment, or change their mind?
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At the end of the day, we have an on-call procedure to get someone down to get vaccinated to make sure that if that last dose wasnt needed or someone canceled their appointment, that we have someone else to fill in so we can use the entire amount of doses, says Di Cubellis.
Vaccines For Adolescents: A New Generation Of Vaccines
Adolescents, like adults, were recommended to get tetanus boosters every 10 years most requiring their first booster dose around age 11. Other than this, however, most adolescents did not require additional vaccines unless they missed one in childhood. By 2005, vaccines specifically recommended for adolescents were only recommended for sub-groups based on where they lived or medical conditions that they had. However, a new group of vaccines became available in the latter part of the decade.
- New vaccines: Tdap, 2005, meningococcal conjugate , HPV , meningococcal serogroup B vaccine
- Additional recommendations for existing vaccines: HPV , intranasal influenza vaccine
- New versions of existing vaccines: HPV
- Discontinuation of vaccine: intranasal influenza vaccine
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The History Of Covid Vaccine Development
A year has passed since the UK became the first western country to license a vaccine against Covid
It has been a year since the UK became the first western country to license a vaccine against Covid and since then the world has embarked on a battle against the virus.
Here is a history of the vaccination development
Half Doses Third Doses Kids Doses: Covid Vaccine Delivery Goes Next
On Nov. 19, the FDA broadened the eligibility for Covid vaccine boosters to all adults 18 and older. On Dec. 9, the FDA and the CDC announced that people who are aged 16 and 17 can receive a booster shot. The Pfizer booster is the only one authorized for people under age 18.
Both the Pfizer and Moderna boosters are available to people six months or later after the second dose in the series.
Not so with the J& J booster. The company had wanted the booster to be given six months or more after the initial shot, except in rare circumstances. But FDAs vaccine advisers rejected that idea, expressing concern about the level of protection people get from the single shot. They recommended that everyone who got the J& J vaccine should be vaccinated two months after the first dose with a catchup period for people who are already further out from their first shot.
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Other Vaccines In The Pipeline
These are just a few of the vaccine candidates in development. Others that could help slow the pandemic, including the vaccine developed by Sinovac Biotech in China, utilize more conventional designs, such as an inactivated virus . It remains to be seen how well all of these approaches may work. But with so many efforts underway, there is good reason to hope that the end of this pandemic nightmare is in sight.
And when it does end, scientists will have many tools ready-made for when the next pandemic hits.
Read more about the coronavirus outbreak from Scientific Americanhere. And read coverage from our international network of magazines here.
What Challenges The Uk Faces In Covid Vaccine Distribution
For many, seeing these shots injected into Britons’ shoulder muscles will come as a much-needed morale boost at the end of a hellish year globally one that’s seen 1.5 million people killed, 65 million others sickened, and countless more subjected to economic hardship.
Symbolism aside, the reality is that even wealthy countries such as the U.S. and the United Kingdom face an enormous logistical challenge in trying to vaccinate priority groups let alone everyone else.
“This feels like the beginning of the end,” professor Stephen Powis, the National Health Services national medical director, said Sunday ahead of the rollout. “But, of course, it is a marathon, not a sprint, and it will take many months to vaccinate everybody who needs vaccination.”
NHS England Chief Executive Sir Simon Stevens added, “Less than a year after the first case of this new disease was diagnosed, the NHS has now delivered the first clinically approved Covid-19 vaccination that is a remarkable achievement.”
Americans will likely not be far behind, with the Food and Drug Administration expected to meet in days to discuss BioNTech-Pfizer’s application for emergency use authorization. Next week, the FDA will meet to rule on another vaccine, made by Moderna.
The Chinese and the Russian governments have given emergency approval to several of their vaccines. But these are all still going through Phase 3 trials or have scant publicly released data.
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Concerns Over Mrna Vaccine
According to Dr. Kenyon, misinformation surrounding mRNA vaccines stems from a concern that the vaccine infects people with the virus.
Nobody is getting infected with a COVID-19 vaccine. It is only the surface protein that would be replicated because we have given you the messenger RNA. It is not the entire virus, he explained.
One misconception is that an mRNA vaccine would not be useful when the virus mutates.
A July 2020 study that appears in Frontiers in Microbiology confirms that the virus mutates. After analyzing 48,635 samples of SARS-CoV-2, the researchers identified an average of 7.23 mutations per sample.
While mutations are a certainty, Dr. Sun said that this should not be a cause for alarm.
There has been an estimated 250,000 variants or strains of SARS-CoV-2 sequenced in the lab. For the most part, the virus has a low mutation rate compared to the mutation rate of the influenza virus , Dr. Sun explained. The spike protein is important for the ability of the virus to infect humans cells. I think it would not mutate enough for the vaccines to be ineffective.
Another concern is whether natural immunity would be more effective than a vaccine. However, a CDC study from November 2021 found that COVID-19 mRNA vaccines are about five times more effective in preventing hospitalization than a previous infection.
Dr. Kenyon said that before any clinical trial can start, a data monitoring and safety board must approve a study protocol.