Trevor James
The ongoing COVID-19 pandemic has led to the development of several vaccines, with Moderna, Pfizer/BioNTech, and Novavax being the most prominent. While these vaccines have been successful in curbing the spread of the virus and reducing severe illness and death, the virus continues to evolve, leading to the emergence of new variants and the need for updated vaccines. As a result, vaccine manufacturers are working on new formulas to target specific variants, such as the JN.1 strain and its subvariants, with the goal of providing better protection against COVID-19, especially for vulnerable populations. These updated vaccines are expected to be available for the 2024-2025 and 2025-2026 seasons, with the FDA and other regulatory bodies evaluating and approving them for use.
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What You'll Learn
Updated COVID-19 vaccines for 2024-2025
The 2024–2025 COVID-19 vaccines are updated to provide better protection from the currently circulating strains. The vaccines more closely target the JN.1 lineage of the Omicron variant. The FDA has approved and authorized for emergency use the updated COVID-19 vaccines (2024-2025 formula). Specifically, the FDA has authorized the Moderna COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 11 years of age, the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) for individuals 12 years of age and older, and the Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 11 years of age.
The CDC recommends COVID-19 vaccination for everyone ages 6 months and older, including women who are pregnant, breastfeeding, or might become pregnant in the future. The CDC also recommends a 2024-2025 COVID-19 vaccine for most adults ages 18 and older, including people who have received a COVID-19 vaccine, people who have had COVID-19, and people with long COVID. Getting the 2024–2025 COVID-19 vaccine is especially important for those who are pregnant, breastfeeding, trying to get pregnant, or might become pregnant in the future, as well as those who are 65 or older or at high risk for severe COVID.
The new shots are expected to provide protection against severe illness, hospitalization, and death related to COVID. Dr. Scott Roberts, a Yale Medicine infectious diseases specialist, recommends the updated vaccines as the best way to protect against COVID infection and severe outcomes. He emphasizes that COVID will never go away and that we can expect an increase in cases during the winter. Dr. Roberts also highlights the importance of keeping up with vaccinations that match the circulating strains as closely as possible.
It is worth noting that the FDA initially advised focusing on an updated vaccine aimed at the JN.1 variant but later recommended targeting the KP.2 variant, which had been gaining traction. As of mid-October 2024, the KP.3.1.1 variant has become the dominant strain, accounting for 57.2% of cases, followed by the XEC strain at 10.7%. Despite the emergence of new strains, Dr. Roberts expects the new shots to continue providing protection against severe illness, even if the virus mutates further.
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COVID-19 vaccines for 2025-2026
The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on 22 May 2025 to discuss and make recommendations on the selection of the 2025-2026 formula for COVID-19 vaccines for use in the United States. The committee unanimously voted to recommend a monovalent JN.1-lineage vaccine composition. The FDA has advised manufacturers of approved COVID-19 vaccines to more closely match currently circulating SARS-CoV-2 viruses. The COVID-19 vaccines for use in the United States beginning in the fall of 2025 should be monovalent JN.1-lineage-based COVID-19 vaccines (2025-2026 formula), preferentially using the LP.8.1 strain.
The 2025-2026 COVID-19 vaccines are expected to be updated annually to provide better protection against COVID-19 caused by circulating variants. The FDA has approved and authorised updated COVID-19 vaccines (2024-2025 formula) for emergency use, and the CDC recommends that all adults get the most updated COVID vaccine annually to help protect against seasonal waves of cases.
The 2024-2025 COVID-19 vaccines more closely target the JN.1 lineage of the Omicron variant. The FDA has approved the following vaccines for emergency use: Moderna COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 11 years of age; Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) for individuals 12 years of age and older; and Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 11 years of age.
The CDC recommends a 2024-2025 COVID-19 vaccine for most adults aged 18 and older, including those who have already received a COVID-19 vaccine, those who have had COVID-19, and those with long COVID. It is especially important to get the 2024-2025 COVID-19 vaccine if you are aged 65 and older, are at high risk for severe COVID-19, or have never received a COVID-19 vaccine. The CDC also recommends COVID-19 vaccination for everyone aged 6 months and older, including women who are pregnant, breastfeeding, or might become pregnant in the future.
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Flu vaccines for 2024-2025
Flu vaccines are updated and distributed annually to protect against the influenza virus, which is known to mutate and spawn new strains. For the 2024-2025 influenza season, the CDC recommends trivalent influenza vaccines, which protect against three different influenza viruses: one influenza A(H1N1) virus, one influenza A(H3N2) virus, and one influenza B/Victoria lineage virus. This is a change from previous years, when quadrivalent (four-component) flu vaccines were used. The decision to switch to trivalent vaccines was made because the influenza B/Yamagata vaccine component is being removed from U.S. flu vaccines. Influenza B/Yamagata viruses have not been detected by global flu surveillance since March 2020, and the risk of infection with these viruses is currently considered low.
The CDC conducts studies each year to determine the effectiveness of flu vaccines in providing protection against the flu. The CDC recommends that everyone aged 6 months and older receive an annual flu vaccine, and that September and October are the best times for most people to get vaccinated. Vaccination is typically recommended while the flu virus is in circulation, which is usually from October through May.
The flu vaccine is an important tool in preventing the spread of the influenza virus and reducing the severity of illness in those who do become infected. It is safe to receive the flu vaccine at the same time as other vaccines, such as the COVID-19 vaccine.
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RSV vaccines for older adults
Respiratory syncytial virus, or RSV, is a highly contagious virus that causes infections of the lungs and breathing passages. RSV is a serious disease, especially for older adults, as it can cause a lung infection similar to the flu. In older adults, it is a common cause of lung disease, which can lead to life-threatening pneumonia.
The RSV vaccine can help older adults at risk of RSV. The Centers for Disease Control and Prevention (CDC) recommends that adults 75 years old and older should receive the RSV vaccine. Adults aged 60-74 years who are at an increased risk of severe RSV disease should also receive the vaccine. The CDC states that the RSV vaccine is not currently an annual vaccine, and protection from the vaccine lasts more than a year. Therefore, if you have received an RSV vaccine already, you should not get another one at this time.
There are three different RSV vaccines used for adults 60 years old or older, made by Pfizer, GSK, and Moderna. The vaccines are called Abrysvo, Arexvy, and mResvia, respectively. The Pfizer vaccine is supplied as a single-dose vial of 120 μg of lyophilized preF antigen component (60 μg from RSV-A, 60 μg from RSV-B) to be reconstituted with sterile water. The Moderna vaccine consists of a single 0.5 mL-dose vial containing 50 μg of nucleoside-modified mRNA encoding the RSV F glycoprotein. The GSK vaccine is supplied in two vials that must be reconstituted prior to administration. One vial is a lyophilized antigen component, and the other is a liquid diluent adjuvant suspension.
The RSV vaccine is recommended for older adults with conditions that make serious disease more likely, such as lung, heart, kidney, or liver diseases, diabetes, or problems with the immune system. It is also recommended for older adults who are at greater risk of hospitalization or death from RSV.
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Inovio's DNA-based vaccine
Inovio Pharmaceuticals has developed a DNA-based vaccine candidate, INO-4800, for COVID-19. In February 2020, Inovio announced that it had produced a preclinical DNA-based vaccine as a potential therapy for COVID-19 after receiving the details of the coronavirus's genetic sequence. The company began human Phase I safety studies of INO-4800 in the United States in April 2020, and a Phase I-II trial in South Korea to test for immunization against the COVID-19 virus. The vaccine candidate was also chosen by the World Health Organization for its Global Covid-19 Trial, termed the Solidarity Trial Vaccines, in October 2021.
INO-4800 has demonstrated excellent safety and tolerability, with no serious adverse events reported in the Phase 1 clinical trial. The vaccine was evaluated in two groups of 20 participants, receiving either 1.0 mg or 2.0 mg of the vaccine intradermally, followed by CELLECTRA® EP at 0 and 4 weeks. Thirty-nine subjects completed both doses, and all 38 subjects evaluable for immunogenicity had cellular and/or humoral immune responses following the second dose. INO-4800 was also found to induce T cell immune responses, in addition to eliciting neutralizing antibodies.
The Phase 1 clinical trial results suggest that INO-4800 has a pristine safety profile and that immunization induces both humoral and cellular responses, supporting its further development to prevent infection, disease, and death in the global population. The vaccine's safety profile could make it a preferred option for high-risk populations, such as the elderly and those with co-morbid conditions. Additional trials are planned to further study the vaccine's efficacy.
In June 2020, Inovio partnered with the International Vaccine Institute and Seoul National University, South Korea, to advance human research on INO-4800 in a Phase I-II safety and efficacy trial conducted on 120 participants. However, in April 2021, the U.S. Department of Defense discontinued funding for the phase III portion of the ongoing trial due to the broad availability of other COVID-19 vaccines in the U.S. Inovio has partnerships in place to scale up production if preliminary efficacy trials are successful.
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Frequently asked questions
Yes, new COVID-19 vaccines for the 2024-2025 season have been approved by the FDA to provide better protection against currently circulating variants.
The CDC recommends that everyone aged 6 months and older receive one of the updated vaccines, especially those who have never received a COVID-19 vaccine, are 65 or older, are at high risk of severe COVID, live in a long-term care facility, or are pregnant, breastfeeding, trying to get pregnant, or might become pregnant in the future.
The FDA has authorized the following vaccines for emergency use:
- Moderna COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 11 years old.
- Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) for individuals 12 years of age and older.
- Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 11 years old.
According to Dr. Roberts, the new COVID shots are called "updated" vaccines and are expected to be updated annually. Boosters, on the other hand, are additional doses of the same or previous formula taken to boost immunity.
