Zika Breaking News

Bavarian Nordic A/S today announced an agreement with Serum Institute of India Pvt. Ltd. ("SII") for its MVA-BN® mpox vaccine.

Under the agreement revealed on December 16, 2024, the companies will undertake a technology transfer of the current manufacturing process for MVA-BN (JYNNEOS®) to SII to enable the supply of the mpox vaccine for the Indian market. Furthermore, upon the relevant regulatory approvals, SII will perform contract manufacturing of MVA-BN, ensuring global access even during outbreaks of mpox.

SII's multifunctional production and one of the most extensive facilities in Pune, India, has an annual capacity of 4 billion doses.

In a press release, SII's CEO Adar Poonawalla said, "The recent mpox outbreak underscores the critical need for a swift and coordinated response. Partnering with Bavarian Nordic on the MVA-BN mpox vaccine reflects our shared commitment to protect millions at risk. Leveraging our manufacturing strength and rapid response capabilities, we aim to enhance epidemic preparedness and expand access to life-saving vaccines, safeguarding vulnerable populations and easing the global burden of mpox."

Bavarian Nordic continues to explore additional opportunities to establish partnerships, including with local African manufacturers, to ensure equitable access to MVA-BN.

Local media recently reported that since 2022, 33 confirmed cases of Mpox have been reported in India. And a Surveillance Program has been recently instructed to intensify surveillance of Mpox patients at airports. India confirmed its first case of the clade Ib mpox strain in late September 2024.

Since it was approved to protect people from smallpox in 2019, the JYNNEOS brand is now commercially available at many clinics and pharmacies.

From an efficacy perspective, U.S. CDC research published in the journal Emerging Infectious Diseases, Volume 30, Number 10—October 2024, concluded the estimated effectiveness of the 2-dose JYNNEOS vaccine was about 80% against clade 2.

A study announced in March 2024 showed that JYNNEOS antibodies waned within a year.

Vaccine efficacy data against clade I mpox is pending.

Novavax, Inc. today announced progress in advancing its corporate growth strategy through its partnership with Sanofi, a Paris, France based company.

Novavax has achieved a milestone associated with its Phase 2/3 clinical trial for its COVID-19 vaccine in children, triggering Sanofi's first $50 million milestone payment.

Novavax's COVID-19 vaccine is included in Sanofi's two combination vaccine candidates for the prevention of influenza and COVID-19, for which Phase 1/2 trials were initiated, and the U.S. FDA Fast Track designation was recently granted in the U.S.

n addition to milestones for the stand-alone COVID-19 vaccine, the agreement also includes combination products developed by Sanofi including Novavax's COVID-19 vaccine, which present a potential opportunity of up to an additional $350 million for Novavax in future milestones.

In addition, stand-alone COVID-19 sales and potential sales of any Sanofi combination products would net Novavax ongoing tiered royalties.

Further, Novavax is eligible to receive up to $200 million for the first four products created by Sanofi utilizing its Matrix-M adjuvant and up to $210 million in milestone payments for each product, including Matrix-M thereafter, plus ongoing royalties for all Sanofi products utilizing Matrix-M.

The European CDC today reported that the United Kingdom confirmed the notification of circulating vaccine-derived poliovirus type 2 (cVDPV2) isolated from environmental samples. 

As of December 13, 2024, the ECDC stated that cVDPV2 was isolated from environmental samples collected in Leeds, London, and East Worthing over the past few months. However, no human cases of polio have been reported in the U.K. in 2024.

Regarding polio preventive vaccines, a recent report from the September Strategic Advisory Group of Experts on Immunization meeting recommended the concomitant use of IPV and type 2 novel oral polio (nOPV2) vaccines in initial outbreak response vaccination campaigns.

Since 2000, the IPV vaccine has been offered in the United States.

And over the past few years, about 1.1 billion nOPV2 vaccine doses have been administered in Africa.

Since August 2024, the U.S. CDC has issued a Level 2—Practice Enhanced Precautions, Travel Health Advisory, listing 37 countries reporting poliovirus detections this year. The CDC writes that adults who previously completed the full, routine polio vaccine series may receive a single, lifetime booster dose of polio vaccine before traveling to any destination listed.

The U.K. is not included in the CDC's current list.

The U.S. CDC announced today that it supports the new Dosing Interval and Schedule for the Bexsero® MenB-4C Vaccine based on the Updated Recommendations of the Advisory Committee on Immunization Practices in October 2024.

On December 12, 2024, the CDC's MMWR (73(49);1124–1128) recommended MenB-4C as a 2-dose series with doses administered at intervals of 0 and 6 months for healthy adolescents and young adults aged 16–23 based on shared clinical decision-making and as a 3-dose series with doses administered at 0, 1–2, and 6 months for persons aged ≥10 years at increased risk.

This news is very relevant for teenagers and college students as real-world evidence suggests that Bexsero provides cross-protection against gonorrhea, a sexually transmitted disease.

For example, the U.K.'s Joint Committee on Vaccination and Immunisation recommended a routine targeted vaccination program in 2023 using the 4CMenB to prevent gonorrhea. 

The U.S. NIH recently announced the antiviral drug tecovirimat, known commercially as TPOXX®, did not reduce the time to lesion resolution or have an effect on pain among adults with mild to moderate clade II mpox and a low risk of developing severe disease.

A planned interim analysis at 75% of the current study's target enrollment showed no difference in the time to lesion resolution between participants treated with tecovirimat compared with those who received a placebo.

This finding is based on an interim data analysis from an international clinical trial called the Study of Tecovirimat for Mpox (STOMP). 

Considering these definitive findings, the study's Data Safety and Monitoring Board recommended stopping further enrollment of participants who were being randomized to tecovirimat or placebo. 

At the Board's request, an additional assessment was performed. Based on the study design and available data, there was less than a 1% chance that the study would show that tecovirimat would be effective if it were to complete enrollment and follow-up.

"The initial STOMP findings provide valuable insight to inform clade II mpox medical countermeasures and underscore the critical importance of conducting well-designed randomized clinical trials during infectious disease outbreaks," said NIAID Director Jeanne Marrazzo, M.D., M.P.H., in a media release on December 10, 2024.

"Before 2022, no treatment candidate had been studied in people with mpox, and this trial is a critical step in our systematic evaluation of existing antivirals like tecovirimat while pursuing novel antivirals and antibody-based mpox therapeutics."

The Food and Drug Administration initially approved SIGA Technologies, Inc.'s Tecovirimat to treat smallpox.

Mpox is caused by a virus that spreads mainly through close contact. Two virus types, clades I and II, have been identified and are historically present in Central and West Africa.

A clade II subtype virus caused a global mpox outbreak in 2022, and the virus continues to circulate at low levels.

In 2024, the World Health Organization declared a Clade I outbreak in Central and East African countries a public health emergency of international concern.

Travel-related cases of clade I mpox have been reported internationally, and the first reported case in the United States was diagnosed on November 15, 2024.

The U.S. CDC has issued a Level 2 travel advisory regarding the Mpox outbreak.

According to a study published in The BMJ, the rate of essential childhood vaccinations has recently decreased in the U.K. The vaccination schedule in England protects children against 15 vaccine-preventable diseases, and vaccines are administered from ages 8 weeks to 14 years.

Published on December 11, 2024, these researchers analyzed vaccination rates at general practices for MMR, rotavirus, pneumococcal conjugate booster, and a six-in-one shot that includes diphtheria, tetanus, and polio vaccinations. 

For example, the estimated cumulative number of 5-year-olds susceptible to measles infection over the study period increased 15-fold in the least deprived group.

This study revealed that vaccination rates in England have declined steadily since 2013, with few in the routine vaccination schedule. For all childhood vaccinations studied, the uptake rates in England did not exceed the WHO recommended threshold of 95% in the more deprived populations.

As of December 12, 2024, the U.S. CDC says that when visiting the U.K., one should be aware of current health issues such as measles.

The U.S. FDA confirmed the 188th Meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will be conducted on December 12, 2024,

The Briefing Document for this digital meeting states the VRBPAC will meet in open session to discuss considerations for Respiratory Syncytial Virus [RSV] vaccine safety in pediatric populations. The FDA wrote, "The observed imbalance in severe/very severe cases of RSV LRTI in the mRNA-1345 and mRNA-1365 vaccine development program among 5-month to <8-month-old recipients of mRNA-1345 (15 μg) and mRNA-1365 (15 μg) has uncertain implications for the ongoing and future pediatric development of other non-live attenuated RSV vaccines."

Moderna's mRNA-1345 is an investigational RSV vaccine with a single mRNA sequence encoding for a stabilized prefusion F glycoprotein. The vaccine uses the same lipid nanoparticles (LNPs) as in the Moderna COVID-19 vaccines. The F glycoprotein is on the virus's surface and is required for infection by helping the virus enter host cells. It exists in two states: prefusion and postfusion. The prefusion conformation is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes.

The draft Agenda overview is as follows:

1. Clinical and Nonclinical Aspects of RSV Vaccine Safety in Young Children.
2. Review of Investigational RSV (mRNA-1345) and RSV/hMPV (mRNA-1365) Vaccines in Infants and Children < 2 Years.
3. Imbalance in Severe RSV Cases in a Clinical Trial of an RSV Vaccine in Infants and Young Children.
4. Committee Discussion of Considerations for RSV Vaccine Safety in Pediatric Populations.

The FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. This is the YouTube link.

Advisory committees provide independent expert advice to the FDA on broad scientific topics or specific products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.