Five Vaccines Approved by the FDA in 2023: Covering Four Disease Categories, Including Three Global Firsts

Dec 27, 2023 13:57 CST Updated 13:57

GSK

Pharmaceutical R&D Manufacturer

Pfizer

Pharmaceutical R&D Developer

Emergent BioSolutions

Biological Pharmaceutical Professional Manufacturer

Valneva

Infectious Disease Prevention Vaccine Developer

According to statistics from WuXi AppTec,CBER under the FDA in 2023(Center for Biologics Evaluation and Research, Center for the Evaluation and Research of Biological Products, responsible for the review of blood, vaccines, cell therapies, and gene therapy biological applications)A total of 14 new therapies were approved, including 5 vaccines.The following is specific information about vaccines approved this year.

Chart 1: Status of CBER-Approved New Drugs from 2016-2023 (Source: WuXi AppTec)

Chart 2: Five vaccines approved for marketing by the FDA in 2023 (Source: WuXi AppTec, official websites of respective companies, etc.)

1
Arexvy

May this yearGSK's Arexvy Receives U.S. FDA Approval for the Prevention of RSV-Caused Lower Respiratory Tract Disease (LRTD) in Adults Aged 60 and Above.This is the world's first approved RSV vaccine, and also the first RSV vaccine to demonstrate significant statistical and clinical efficacy in individuals aged 60 years and above.Subsequently, Arexvy was successively approved for marketing in Europe, Canada, Japan, and other countries.

On October 25, GSK released positive preliminary results from the Phase III trial (NCT05590403) of Arexvy: The immune response of Arexvy in adults aged 50-59 was non-inferior to its performance in adults aged 60 and above, including the subgroup with underlying medical conditions.GSK's RSV Vaccine Phase III Trial Shows Positive Preliminary Results, Potential Expansion to Include Ages 50-59!）

In terms of market performance, according to data released by GSK, Arexvy has captured nearly two-thirds of the U.S. RSV vaccine retail market, with 1.4 million American adults already vaccinated. Currently, approximately 83 million adults over the age of 60 in the U.S. are at risk of RSV. GSK's financial report indicates that Arexvy’s total sales for 2023 could exceed $1 billion. The vaccine generated sales of £709 million (approximately $860 million) in its first quarter on the market.

2
Abrysvo

On May 31, Pfizer announced that the U.S. FDA had approved its bivalent respiratory syncytial virus (RSV) vaccine, Abrysvo, for the prevention of acute respiratory disease and lower respiratory tract disease caused by RSV in individuals aged 60 years and older.This is the second RSV vaccine approved globally.

According to the phase 3 clinical trial RENOIR of the Abrysvo vaccine, compared with placebo, Pfizer's candidate RSVpreF vaccine was 66.7% effective (96.66% CI: 28.8-85.8) in preventing RSV-related lower respiratory tract disease with at least two symptoms, and 85.7% effective (96.66% CI: 32.0-98.7) in preventing infections with three or more symptoms. In addition, the vaccine was well tolerated and no safety concerns were identified. It is reported that the trial recruited approximately 37,000 participants.

Chart 3: Comparison of AREXVY and ABRYSVO (Source: PatSnap Pharma Intelligence)

On August 21, Pfizer announced that the FDA approved Abrysvo for active immunization of pregnant women at 32 to 36 weeks of gestation to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth to six months. This is the first and only maternal vaccine approved to help protect newborns from RSV infection within the first six months after birth.

In terms of market performance, Abrysvo's sales reached $375 million in the third quarter of this year. According to relevant data, GSK's Arexvy has been administered to 1.4 million people so far, while Pfizer's Abrysvo has only reached 800,000 people. Compared with GSK's Arexvy, Pfizer's Abrysvo is currently slightly inferior.

3
Cyfendus

Cyfendus is made from the cell-free filtrate of microaerophilic cultures of a non-toxic, non-encapsulated strain of Bacillus anthracis.The administration of two doses (0.5mL each) via intramuscular injection within 14 days using an additional adjuvant can elicit a protective level of immune response.

On July 20, Emergent BioSolutions announced that the U.S. Food and Drug Administration (FDA) had approved Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted, formerly known as AV7909) for post-exposure prophylaxis of disease in individuals aged 18 to 65 suspected or confirmed to have been exposed to Bacillus anthracis, when used in conjunction with recommended antibacterial drugs. The efficacy of the Cyfendus vaccine for post-exposure prophylaxis is based solely on studies using an inhalational anthrax animal model.

Emergent BioSolutions is a company dedicated to developing specialty vaccines and antibody therapies for infectious diseases like cholera and opioid overdose, as well as providing medical devices for biodefense purposes. Its products include the controversial anthrax candidate vaccine, and in recent years, it has extensively assisted and participated in government efforts to formulate preparedness and response strategies.

FDA Approval of Cyfendus Vaccine Based on Data from Studies Supported by the U.S. Government and Conducted by Emergent BioSolutionsThe FDA approval of Cyfendus vaccine is based on data from a series of studies supported by the U.S. government and conducted by Emergent BioSolutions. According to a multicenter, randomized, double-blind, parallel-group Phase 3 study evaluating the lot consistency, immunogenicity, and safety of CYFENDUS versus BIOTHRX in adults aged 18 to 65, 66.3% of patients receiving CYFENDUS achieved vaccine-induced TNA 50% neutralization factor (NF50) ≥0.56 on Day 64 (primary endpoint). CYFENDUS was also found to be non-inferior to BIOTHRX based on the percentage difference between participants reaching the threshold TNA NF50 ≥0.29 on Day 64 (primary endpoint).

4
Penbraya

On October 20, the FDA approved Pfizer's pentavalent meningococcal vaccine Penbraya for marketing. This is the world's first and only pentavalent vaccine, used to prevent the most common serotypes of meningococcal disease in people aged 10 to 25.

Meningococcal disease is caused by the bacterium Neisseria meningitidis. This bacterium has 13 different serogroups, of which six—A, B, C, W, X, and Y—are responsible for the majority of cases worldwide.

Penbraya combines the components of two meningococcal vaccines, namely Trumenba (MenB vaccine) and Nimenrix (MenACWY conjugate vaccine), helping to prevent the five most common meningococcal serogroups responsible for the majority of invasive meningococcal disease (IMD) cases globally. Notably, Penbraya has the potential to provide the broadest meningococcal coverage with the fewest number of injections in a single vaccine.

According to a randomized, active-controlled, and observer-blinded Phase 3 trial, participants who received the PENBRAYA pentavalent vaccine demonstrated non-inferior immune responses across all five serotypes compared to two doses of Trumenba plus one dose of Menveo.

5
Ixchiq

On November 10, Valneva announced that the FDA had approved the single-dose attenuated live vaccine Ixchiq (VLA1553 vaccine) for the prevention of diseases caused by the chikungunya virus (CHIKV). The vaccine is approved for use in individuals aged 18 and older who are at increased risk of exposure to CHIKV.The continued approval of IXCHIQ in the United States depends on the verification of clinical benefits in confirmatory studies.

According to a Phase 3 clinical trial of Ixchiq, 98.9% of participants who received Ixchiq had neutralizing antibodies against the chikungunya virus at protective levels 28 days after vaccination. Six months after vaccination, 96.3% of participants still had sufficient antibodies against the chikungunya virus. In terms of safety, the most common adverse reactions to the vaccine were injection site pain, headache, fatigue, myalgia, arthralgia, fever, and nausea. Regarding these adverse reactions, the FDA has required post-marketing studies to evaluate the vaccine.

Currently, apart from Ixchiq, there are four Chikungunya virus vaccines under development globally: PXVX-0317 by Bavarian Nordic, Chikungunya virus vaccine by Bharat, MV-CHIK by Themis, and ChAdOx1 Chik △Cap by the University of Oxford. Among them, PXVX-0317 is expected to submit a regulatory application in 2024 and may become the world's second Chikungunya virus vaccine.Second in the World: Positive Phase 3 Trial Results for Chikungunya Virus Vaccine）

Figure 4: Chikungunya Virus Vaccines in Global Research (Source: Pharma Intelligence)

References:

[1] 2023 FDA New Drug Roundup: Small Molecules Dominate, New Mechanism Therapies Reach New Heights. WuXi AppTec. 2023-12-25.

[2] The First Round of the RSV Vaccine Battle: Has the World's Largest Pharmaceutical Company Lost?. Artery New Medicine. 2023-11-02.

[3]CYFENDUS Receives U.S. FDA Approval for Post-Exposure Prophylaxis of Bacillus Anthracis. Infectious Insights. 2023-07-24.

[4] The World's First Pentavalent Meningococcal Vaccine Approved, Pfizer's Penbraya Takes the Crown! Yisai Consulting. 2023-10-24.

[5] A New "Vaccine Development" Race Targeting Mosquitoes. Pharma Intelligence Network. 2023-11-15.

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Five Vaccines Approved by the FDA in 2023: Covering Four Disease Categories, Including Three Global Firsts

GSK

Pfizer

Emergent BioSolutions

Valneva

1Arexvy

2Abrysvo

3Cyfendus

4Penbraya

5Ixchiq

1
Arexvy

2
Abrysvo

3
Cyfendus

4
Penbraya

5
Ixchiq