Chloe Ramirez
The COVID-19 pandemic saw the rapid development and approval of the first mRNA vaccines. In December 2020, BioNTech and Moderna obtained approval for their mRNA-based COVID-19 vaccines. The Pfizer–BioNTech COVID-19 vaccine was the first to receive emergency use authorization from the FDA, with Moderna's vaccine receiving similar approval a week later. Since then, the FDA has approved updated mRNA COVID-19 vaccines, including Comirnaty and Spikevax, for individuals aged 12 and above. The success of mRNA COVID vaccines has spurred interest in exploring mRNA technology for other diseases, with several mRNA vaccines currently in the pipeline for conditions such as the flu, Zika virus, and cancer.
| Characteristics | Values |
|---|---|
| mRNA vaccines approved by the FDA | Comirnaty, Spikevax, Moderna COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine |
| Eligible age group | 12 years and older |
| Additional doses | Certain immunocompromised individuals aged 6 months to 11 years |
| Side effects | Similar to previously reported side effects of mRNA COVID-19 vaccines |
| Formula | 2024-2025 |
| Protection | Against currently circulating variants of COVID-19 |
| mRNA vaccine technology | Used for the prevention of other diseases, such as the flu, RSV, Zika virus, and cancer |
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What You'll Learn
Approved mRNA COVID-19 vaccines
The US Food and Drug Administration (FDA) has approved and authorised updated mRNA COVID-19 vaccines for emergency use to better protect against currently circulating variants. The vaccines are designed to provide better protection against serious consequences of COVID-19, including hospitalisation and death. The approved vaccines include Comirnaty and Spikevax, which are approved for individuals 12 years of age and older. The Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine are authorised for emergency use for individuals 6 months through 11 years of age. Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the Pfizer-BioNTech COVID-19 Vaccine or two doses of the Moderna COVID-19 Vaccine.
The updated mRNA COVID-19 vaccines are manufactured using a similar process as previous formulas, and the benefits of these vaccines continue to outweigh their risks. The FDA will continue to review any additional COVID-19 vaccine applications and take appropriate regulatory action. The approval of Comirnaty (2024-2025 Formula) was granted to BioNTech Manufacturing GmbH, while the EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) was issued to Pfizer Inc. The approval of Spikevax (2024-2025 Formula) was granted to ModernaTX Inc. and the EUA amendment for the Moderna COVID-19 Vaccine (2024-2025 Formula) was also issued to ModernaTX Inc.
The updated mRNA vaccines have been studied for their effectiveness against currently circulating variants, and the results indicate that they offer a similar level of protection as the previous versions did against the variants they were designed for. The benefit-risk profile of the mRNA COVID-19 vaccines is well understood, as they have been administered to hundreds of millions of people in the United States. The vaccines are expected to provide protection against COVID-19 caused by the currently circulating variants.
The FDA has also approved updated mRNA COVID-19 vaccines for the 2023-2024 season, manufactured by ModernaTX Inc. and Pfizer Inc. These vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5. Individuals 12 years of age and older are eligible to receive a single dose of the updated, approved Comirnaty or Spikevax, with a minimum interval of 2 months since the last dose of any COVID-19 vaccine.
Pfizer's COVID-19 vaccine was the first mRNA product to achieve full FDA approval in the US.
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The future of mRNA vaccines
MRNA vaccine technology has been in development for decades, but with COVID-19, it got its moment to prove its safety and effectiveness. The first mRNA product to achieve full FDA approval in the US was Pfizer's COVID-19 vaccine. Following this success, vaccine manufacturers are now developing mRNA vaccines to protect against other respiratory viruses, such as the flu. Moderna is also exploring the use of mRNA technology to protect against HIV.
The advantages of mRNA vaccines lie in their rapid development times, lower costs, and ability to be easily modified, in contrast to traditional vaccines that use a weakened or dead version of the virus. mRNA vaccines use a genetic code to instruct the body's cells to produce proteins that train the immune system, resulting in "plug-and-play" vaccines. The future of mRNA vaccines will include the optimization of nanoparticles used for delivery, as well as the mRNA itself.
Researchers at Penn Medicine are developing an mRNA-based vaccine against all 20 known subtypes of the influenza virus. If successful, this universal flu vaccine will provide a baseline level of immune memory against diverse flu strains and protect against future flu pandemics. Penn Medicine researchers are also working on an mRNA vaccine to combat leptospirosis, a bacterial disease common in Southeast Asia.
The UK is also at the forefront of advancing mRNA technology, with over 75 leading scientists, clinicians, and industry experts collaborating to discuss the latest advances and applications. The future of mRNA technology includes understanding how ancestry affects immune responses to vaccines and engineering mRNA to enhance T follicular helper cells in the lymph nodes to create more effective vaccines.
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mRNA vaccines for other diseases
The success of mRNA COVID-19 vaccines has led to the exploration of mRNA technology for other uses. Researchers have been developing mRNA technology for decades, and it has allowed scientists to create safe and effective vaccines faster than ever before.
MRNA vaccine technology was first tested in mice in the 1990s, and the first mRNA vaccines for rabies were tested in humans in 2013. The biggest challenge in the early years of mRNA research was that the body would quickly degrade the mRNA before it could deliver its message. This was overcome through advances in nanotechnology, which allowed the development of fatty droplets (lipid nanoparticles) that protected the mRNA, allowing entry into the cells.
Currently, COVID-19 vaccines are the only authorized or approved mRNA vaccines. However, there are several other mRNA vaccines in the pipeline, with many in phase 1 clinical trials and a few in phases 2 and 3. These include vaccines for the flu, cytomegalovirus (CMV), respiratory syncytial virus (RSV), and HIV. A universal mRNA flu vaccine, which would cover multiple strains and last longer than the current annual flu shots, is currently in phase 1 trials.
MRNA vaccines may also offer hope where other vaccines have been unsuccessful, such as in treating cancer and HIV. The technology could potentially be used to develop vaccines for a variety of other diseases in the future.
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The history of mRNA vaccines
Messenger RNA, or mRNA, was discovered in the early 1960s, and research into how mRNA could be delivered into cells was conducted in the 1970s. In 1978, scientists used fatty membrane structures called liposomes to transport mRNA into mouse and human cells to induce protein expression.
In 1988, graduate student Malone at the Salk Institute for Biological Studies in La Jolla, California, jotted down some notes, speculating that if cells could create proteins from mRNA delivered into them, it might be possible to "treat RNA as a drug". Later that year, Malone's experiments showed that frog embryos absorbed mRNA. This was the first time anyone had used fatty droplets to ease mRNA's passage into a living organism.
In the 1990s, the first mRNA flu vaccine was tested in mice, but there were some difficult technical challenges that took a great deal of innovation to overcome. The biggest challenge was that mRNA would be taken up by the body and quickly degraded before it could "deliver" its message—the RNA transcript—and be read into proteins in the cells.
In 2013, the first mRNA vaccines for rabies were tested in humans. The solution to the problem of degradation came from advances in nanotechnology: the development of fatty droplets (lipid nanoparticles) that wrapped the mRNA like a bubble, which allowed entry into the cells. Once inside the cell, the mRNA message could be translated into proteins, like the spike protein of SARS-CoV-2, and the immune system would then be primed to recognize the foreign protein.
The first mRNA vaccines using these fatty envelopes were developed against the Ebola virus, but since that virus is only found in a limited number of African countries, it had no commercial development in the US.
With the COVID-19 pandemic, mRNA vaccine technology got its moment and has proven to be extremely safe and effective. Pfizer's COVID-19 vaccine is the first mRNA product to achieve full FDA approval in the US. The FDA has also approved and authorized for emergency use updated mRNA COVID-19 vaccines (2024-2025 formula) to more closely target currently circulating variants. These include Comirnaty and Spikevax, both of which are approved for individuals 12 years of age and older, and the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, both of which are authorized for emergency use for individuals 6 months through 11 years of age.
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How mRNA vaccines work
The US Food and Drug Administration (FDA) has approved and authorized updated mRNA COVID-19 vaccines for emergency use to better protect against currently circulating variants of the virus. These include Comirnaty and Spikevax, which are approved for individuals aged 12 and above, and the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, authorized for emergency use for individuals aged 6 months to 11 years.
MRNA vaccines use groundbreaking biotechnology to help our bodies fight off infectious diseases like COVID-19. They teach our body's immune system to recognize and defend itself from harmful viruses. mRNA stands for messenger ribonucleic acid, a molecule that carries instructions from DNA to the parts of our cells that make proteins.
MRNA vaccines work by introducing a piece of mRNA that corresponds to a viral protein, usually a small piece of a protein found on the virus's outer membrane. This mRNA tells our cells how to make a harmless viral protein called an antigen. An antigen is a part of a pathogen that could make you ill, but it has been changed so that it is unable to cause disease.
When our cells start making this antigen, our immune system recognizes it as a foreign invader. In response, it produces antibodies that target the antigen. Antibodies are special proteins that help us fight illness by recognizing and neutralizing harmful pathogens before they make us sick. These antibodies can remain in our bodies for many months, allowing our immune system to quickly respond if exposed to the virus again.
It is important to note that mRNA vaccines do not cause genetic mutations or cancer. They never enter the nucleus of cells where our DNA is stored and do not alter DNA. The mRNA in vaccines is only temporary, quickly broken down and flushed out after the cells make the protein.
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Frequently asked questions
Yes, the FDA has approved the updated COVID-19 vaccines Comirnaty and Spikevax for individuals 12 years of age and older. The Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine are also authorized for emergency use for individuals 6 months through 11 years of age.
An mRNA vaccine uses a copy of a molecule called messenger RNA (mRNA) to produce an immune response. The vaccine delivers molecules of antigen-encoding mRNA into cells, which use the mRNA as a blueprint to build foreign proteins that would normally be produced by a pathogen or cancer cell.
Individuals who receive an mRNA vaccine may experience side effects such as aches and fevers. These reactions can be severe but are usually transient. The US FDA has also warned about the possibility of an increased risk of myocarditis and pericarditis for some people.
