Pfizer-BioNTech
Pfizer and BioNTech’s vaccine (trade name: Comirnaty) received full approval from the Food and Drug Administration (FDA) in August 2021 for use in people 16 years of age and older. Before that, the company became the first coronavirus vaccine to receive FDA Emergency Use Authorization (EUA) in December 2020 after reporting that its vaccine was highly effective in preventing symptomatic disease. This is a messenger RNA (mRNA) vaccine and uses relatively new technology. It may be more difficult to distribute than other vaccines because it must be stored at freezer-level temperatures.
Situation: Pfizer’s vaccine has been updated over time to target new virus variants. The original coronavirus mRNA vaccines from Pfizer and Moderna, first introduced in December 2020, protected against the original SARS-CoV-2 virus. Since then, they have been replaced three times with shots targeting different versions of the Omicron strain of the virus. In 2022, a “bivalent” vaccine was developed that targets both the original virus and Omicron’s variants BA.4 and BA.5. In 2023, a monovalent shot targeting the XBB lineage of the Omicron subspecies emerged. And in 2024, there will be a new updated shot aimed at protecting against KP.2, which was widespread in the US earlier this year. Previous vaccines are no longer used.
Target audience: People over 6 months old. The CDC has specific recommendations for the following groups, saying people who have recently been infected with coronavirus may need to consider delaying vaccination for three months.
Children 6 months to 4 years of age require multiple doses, including at least one dose of the 2024-2025 updated vaccine (see CDC’s website for more specific recommendations). Please check the site). Children aged 5 to 11 years can receive one dose of the 2024-2025 updated vaccine. People 12 and older can receive one dose of the 2024-2025 updated vaccine
People over 65 and those with moderate or severe immunodeficiency can receive a second dose six months after the first. People who are moderately or severely immunocompromised may decide to receive additional doses in consultation with their health care provider.
Possible side effects: pain, redness, swelling at the injection site and/or fatigue in the rest of the body, headache, muscle pain, chills, fever, nausea. If these side effects occur, they should go away in a few days. Some side effects are serious but rare. These include anaphylaxis, a severe reaction that can be treated with epinephrine (a drug from EPIPENs®).
FDA Warning: The FDA has added a warning label to mRNA vaccines regarding serious (but rare) cases of inflammation of the heart muscle (myocarditis) and inflammation of the outer layer of the heart (pericarditis) in adolescents and young adults. Second dose of mRNA vaccine. In most cases, inflammation improves on its own without treatment.
How it works: Uses mRNA technology. This is how it sends instructions to host cells in the body to make copies of the spike protein (like the spike sticking out of the coronavirus in the photo). Our cells recognize this protein as something that doesn’t belong, and our immune system responds by activating immune cells to produce antibodies. This allows the body to recognize and attack the real SARS CoV-2 spike protein if exposed to the real virus.
How Effective: The 2024-2025 updated vaccines were approved based on preclinical studies of their effectiveness against circulating strains. Although some people may still get infected even if they are vaccinated, the goal of vaccines right now is to prevent severe disease, hospitalization, and death. Research shows that people who become infected after vaccination are more likely to experience prolonged COVID-19 infection (defined as signs, symptoms, and conditions that continue or develop after an acute COVID-19 infection) than those who were not vaccinated. It has been suggested that people are less likely to report
In its recommendations for the coronavirus vaccine, the CDC states that the risk of heart complications, including myocarditis (inflammation of the heart muscle), in males aged 12 to 17 years is 1.8 to 1.8 compared to males after infection with COVID-19. It cites a study that showed it to be 5.6 times more likely. After receiving the new coronavirus vaccine.
In December 2020, Phase 3 clinical data for the original Pfizer-BioNTech vaccine showed 95% efficacy in preventing symptomatic coronavirus. Subsequent data on real-world efficacy in adults showed that the protective effects of two initial doses of mRNA wane over time, and that an updated vaccine is needed to restore the immune system to robust levels. was suggested.
Additional information is available in the FDA’s Pfizer-BioNTech 2024-2025 Vaccine Fact Sheet.
moderna
The FDA fully approved the Moderna vaccine (brand name: Spikevax) for people 18 and older in January 2022, and raised the EUA for the vaccine granted in December 2020 (one week after Pfizer-BioNTech). . Moderna uses the same mRNA technology as Pfizer-BioNTech, and both companies had shown similar efficacy in preventing symptomatic disease at the time they applied for approval. It also needs to be stored at freezer-level temperatures.
Situation: Moderna’s vaccine has been updated over time to target new virus variants. The original coronavirus mRNA vaccines from Pfizer and Moderna, first introduced in December 2020, protected against the original SARS-CoV-2 virus. Since then, they have been replaced three times with shots targeting different iterations of the Omicron strain. In 2022, a “bivalent” vaccine was developed that targets both the original virus and Omicron’s variants BA.4 and BA.5. In 2023, a monovalent shot targeting the XBB lineage of the Omicron subspecies emerged. And in 2024, there will be a new updated shot aimed at protecting against KP.2, which was widespread in the US earlier this year. Previous vaccines are no longer in use.
Target audience: People over 6 months old. The CDC has specific recommendations for the following groups, saying people who have recently been infected with coronavirus may need to consider delaying vaccination for three months.
Children 6 months to 4 years of age require multiple doses, including at least one dose of the 2024-2025 updated vaccine (see CDC’s website for more specific recommendations). Please check the site). Children aged 5 to 11 years can receive one dose of the 2024-2025 updated vaccine. People 12 and older can receive one dose of the 2024-2025 updated vaccine.
People over 65 and those with moderate or severe immunodeficiency can receive a second dose six months after the first. People who are moderately or severely immunocompromised may decide to receive additional doses in consultation with their health care provider.
Possible side effects: Side effects are similar to the Pfizer-BioNTech vaccine: pain at the injection site, redness, swelling, and/or fatigue for the remainder of the period, headache, muscle pain, chills, fever, or nausea. body. If these side effects occur, they should go away in a few days. Some side effects are serious but rare. These include anaphylaxis, a severe reaction that can be treated with epinephrine (a drug from EPIPENs®).
FDA Warning: The FDA has placed a warning label on Moderna’s vaccine regarding a “possible association” with reported cases of heart inflammation in young adults. This inflammation can occur in the heart muscle (myocarditis) or the outer layer of the heart (pericarditis), and often occurs after the second dose of an mRNA vaccine. In most cases, inflammation improves on its own without treatment.
How it works: Like the Pfizer vaccine, this is an mRNA vaccine that sends instructions to host cells in the body to produce the spike protein and trains the immune system to recognize it. The immune system then attacks the spike protein (the one attached to the actual SARS CoV-2 virus) when it sees it.
How Effective: The 2024-2025 updated vaccines were approved based on preclinical studies of their effectiveness against the latest circulating strains. Some people can still get infected even if they are vaccinated, but the goal of vaccines right now is to prevent severe disease, hospitalization, and death. Research suggests that people who become infected after vaccination are less likely to report long coronavirus than those who were not vaccinated.
In its recommendations for the coronavirus vaccine, the CDC states that the risk of heart complications, including myocarditis (inflammation of the heart muscle), in males aged 12 to 17 years is 1.8 to 1.8 compared to males after infection with COVID-19. It cites a study that showed it to be 5.6 times more likely. After receiving the new coronavirus vaccine.
Moderna’s initial Phase 3 clinical data in December 2020 was similar to Pfizer-BioNTech’s, with both vaccines showing about 95% efficacy in preventing the coronavirus. Subsequent data on real-world efficacy in adults showed that protection from the first two doses of mRNA waned over time, but additional doses returned the immune system to robust levels.
Additional information is available in the FDA’s Moderna 2024-2025 Vaccine Fact Sheet.
Novavax
The Novavax vaccine (trade names: Nuvaxovid and Covovax) is the fourth coronavirus vaccine (after Johnson & Johnson, currently unavailable) to be administered in the United States. The Novavax vaccine is the only non-mRNA updated coronavirus vaccine available in the United States. The vaccine is a protein adjuvant that was 90% effective in clinical trials and performed nearly as well as mRNA vaccines in early trials. It is easier to manufacture than other vaccines and can be stored in the refrigerator, making it easier to distribute.
Situation: The FDA approved Novavax’s latest coronavirus vaccine in late August for everyone age 12 and older. Novavax has designed its latest shot to target the KP.2’s predecessor, the JN.1. Novavax’s 2023-2024 vaccine is no longer available in the U.S. as all doses have expired.
Target audience: People over 12 years old. People over 65 and those with moderate or severe immunodeficiency can receive a second dose six months after the first. People who are moderately or severely immunocompromised may decide to receive additional doses in consultation with their health care provider.
Possible side effects: injection site tenderness, fatigue, headache, muscle pain. Rare cases of myocarditis and pericarditis (6 of 40,000 participants) occurred in this clinical trial, as well as rare cases of severe allergic reactions.
How it works: Unlike mRNA and vector vaccines, this is a protein adjuvant (an adjuvant is an ingredient used to boost the immune response). While other vaccines trick the body’s cells into creating parts of the virus that can trigger the immune system, the Novavax vaccine takes a different approach. It contains the coronavirus’s own spike protein, but it is formulated as nanoparticles that cannot cause disease. When a vaccine is injected, it stimulates the immune system to produce antibodies and a T-cell immune response.
How effective: The 2024-2025 updated vaccine targets the JN.1 variant, not KP.2 like Pfizer and Moderna, but Novavax said non-clinical data showed it included: reported that broadly cross-neutralizing antibodies against multiple mutant strains were demonstrated. JN.1, KP.2, and KP.3.
Early research on the company’s original vaccine showed that Phase 3 trial results published in the New England Journal of Medicine in December 2021 showed an overall reduction of 90% against laboratory-confirmed symptomatic infections. % effective and 100% effective against moderate and severe disease.
Additional information is available in the FDA’s Novavax 2024-2025 Vaccine Fact Sheet.
