Major Milestone for Pancoronavirus Vaccines and More (Next Generation Covid Vax Update No 36)

This month, the first clinical trial for a pancoronavirus formulation of an existing Covid vaccine was registered. Although it’s just on the starting blocks, being a variant-adapted version of an approved vaccine could shorten its pathway later on. More on that below. There were also more results from a clinical trial of the durable GeoVax vaccine for people with immunocompromise, as well as 12 preclinical reports.

There’s a change in format for this update. The huge, layout-heavy post overloaded this blog’s memory and had become difficult to update. So I moved the tables tracking vaccines from the post to my personal website. As usual, I have the post broken down into 3 categories of next-generation vaccines (definitions below). Each section ends with an overview of vaccines in the category – and each has a link to skip over that straight to the next news section.

• Mucosal vaccine news
• Durable or “variant-proof” vaccine news
• Pancoronavirus vaccine news
• Addendum 1: List of authorized vaccines (with countries)
• Addendum 2: Definitions of vaccine types
• Addendum 3: Table of mucosal vaccines in clinical trials (here—off this blog)
• Addendum 4: Table of pancoronavirus vaccines with preclinical results (here—off this blog)

• Postscript: US Project NextGen funded trials

Mucosal vaccine news

This month, there is news on trials for 2 mucosal vaccines. There were also 7 preclinical reports for mucosal vaccines, one of which is included in the pancoronavirus section below. The 6 listed below include a previous report for a vaccine that I had missed when it was published.

Clinical trial and development progress

• Intranasal viral vector vaccine from Rokote (Finland): The first phase 1 trial for this nasal spray has been completed, however that version of the vaccine is not progressing directly to phase 2. A phase 1 trial comparing it to a new formulation of the vaccine is planned for January 2026. The company’s CEO reported that preclinical studies had indicated that the new formulation was more effective.

• Intranasal viral vector vaccine from Castlevax (USA): Castlevax is now recruiting 200 participants in Colorado and Massachusetts for a phase 2 trial of their intranasal vaccine. (Contact details here.) The first dose in this trial was administered in early November.

Preclinical results for mucosal vaccines

• Intranasal protein subunit vaccine from the University of Alberta and Access to Advanced Health Institute (Canada, USA): I added 2 reports for this vaccine, including a paper from 2021 I had missed, and a new publication. In the first, injected version followed by intranasal boost protected mice in a Covid challenge test. In the new report, the developers describe freeze-dried powder versions of the intranasal vaccine and tests of its stability and aerosol performance over 10 months. All except one of the formulations showed minimal significant changes.
  

• Inhaled viral vector vaccine from the Biomedical Primate Research Centre, Rijswijk and Friedrich Alexander University (Netherlands, Germany): This is the first report for this vaccine with an adenoviral vector. The developers report on tests in 3 groups of rhesus macaques that were first vaccinated with mRNA vaccine. One group was boosted with the inhaled viral vector vaccine, one was boosted with an inhaled live attenuated vaccine, and the third was infected with the Delta variant to compare the vaccines with exposure to infection. The boosted groups were challenged with an Omicron variant (EG.5.1.1): The developers reported that they showed “almost no upper and lower respiratory tract infection.” The adenoviral vector vaccine induced stronger signs of immune response.
  

• Intranasal viral vector vaccine Beijing Wantai Biopharma (China): This is one of the mucosal vaccines that has been approved in China, marketed as Pneucolin. The viral vector is live attenuated influenza. (All records for this vaccine here.) The new report describes tests of vaccine shedding. This was done because unlike other vaccines, live influenza-based vaccines are potentially transmissible. There had been some signs this might have happened with this vaccine. So they undertook transmissibility tests in ferrets and hamsters, showing that vaccinated animals could spread the vaccine to co-housed animals, with some spreading of immunity.

• Oral yeast vaccine from the University of Santo Tomas (Philippines): This is the first report for this vaccine, in which Covid subunit protein is carried by the yeast, Saccharomyces boulardii, fused with an enterotoxin fragment. It was tested in mice, and the developers report the vaccine induced some signs of immune response (but not an IL-4 response).

• Inhaled protein subunit vaccine with pulmonary surfactant from the National Center for Nanoscience and Technology (China): This is the first report for this vaccine, which uses a pulmonary surfactant to increase the delivery of the vaccine into the mucosa. Intramuscular and inhaled vaccines were compared in mice. The addition of the inhalable surfactant adjuvant augmented immune response to vaccine.

Skip ahead to next news category

Mucosal Covid vaccine overview

• 5 mucosal vaccines are currently authorized for use, at least 1 in each of 6 countries. None have been authorized by a drug regulatory agency designated stringent, or listed, by WHO. However, each has been authorized by a regulator which has transitional WHO listing for vaccines.
• 36 mucosal vaccines have reached clinical trial, although some of the vaccines are no longer in development. The vaccines that have entered clinical trials are tracked in a table below. They are mostly viral vector vaccines.
• In addition to the 5 authorized mucosal vaccines, 6 have reached phase 2 trials, and another 2 have reached phase 2/3 trial.

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Durable or “variant-proof” vaccines

This month, there were results from a clinical trial for a vaccine in this category, as well as preclinical reports for 3 vaccines.

More clinical trial results for the GeoVax viral vector vaccine

This vaccine is based on modified Ankara virus (MVA), and was developed at the City of Hope with the NIH’s National Cancer Institute (NCI), to better serve immunocompromised people on cancer treatment. The vaccine is in several clinical trials. (All records for this vaccine here.) The new report includes further interim results of a phase 2 trial of a booster in people with chronic lymphocytic leukaemia. The Geovax booster is being compared with a BNT/Pfizer mRNA vaccine booster dose.

An interim analysis of immune responses for 27 participants was included in this report. All were in remission during the study. The BNT/Pfizer arm of this trial was terminated because the target level of immune response was not reached, while the GeoVax vaccine outperformed it, and the trial is continuing for that group. T-cell responses were superior for the GeoVax vaccine: 40% of the patients reached the primary endpoint versus 14% for the BNT/Pfizer vaccine. Specific T-cell response was also more durable, with responses maintained at 180 days.

There were no severe adverse events reported in the trial. While no participants in this trial became very ill with Covid during the trial, 4 people reported mild Covid infections (3 in the GeoVax group).

Preclinical reports

• mRNA-VLP vaccine from AstraZeneca (USA): This is the first report for this vaccine with virus-like protein antigens instead of LNP (liquid nanoparticle). The developers tested versions based on the Delta variant and a bivalent version including Omicron as well. They report on tests in mice, hamsters (including challenge test), and primates, comparing their vaccine with available mRNA (LNP) vaccine. The AstraZeneca vaccine induced higher immune responses, and maintained a higher response at 6.5 months. This was an extensive group of preclinical tests, but the developers did not report on whether the vaccine would be going into clinical trial.

• Viral vector vaccine from Shiga University of Medical Science and the Tokyo Metropolitan Institute of Science (Japan): This is the second report for this vaccine, with a vaccinia virus vector. (The first is here.) The developers report on further tests in rhesus macaques, including challenge tests with 2 Covid variants. The vaccine induced immune responses and reduced viral responses to challenge in all the animals.

• Multivalent fusion protein vaccine from Taibah University (Saudi Arabia): This is the first report for this vaccine. The vaccine includes 5 proteins from the original Covid and Omicron variants. It was tested in mice, showing immune responses to a range of variants.

Skip ahead to next news category

Durable or “variant-proof” vaccine overview

Note: This is a rather vague category, including vaccines that aim to be more durable. I’m not sure how many can be classified as aiming to be “variant-proof”.

Authorized vaccine:

There is 1 authorized vaccine in this category, and it has been authorized by a drug regulatory authority designated by WHO has stringent, and tested against an mRNA vaccine (Kostaive):

• LUNAR-COV19 (USA), trade name Kostaive: This self-amplifying mRNA vaccine was authorized in Japan in November 2023, with rollout in October 2024. It was also authorized for Europe in February 2025. Application for authorization in the UK planned next.

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Pancoronavirus vaccine news

This month, a trial was registered for the first pancoronavirus formulation of an existing approved Covid vaccine. There were also 3 preclinical reports in this category, including one for an intranasal vaccine.

Clinical trial for pancoronavirus “SKYCovione” registered in Australia

In my October post, I included a company report that they planned on running a phase 1/2 trial in Australia, with results anticipated in 2028. That trial has now been registered here. In phase 1, the trial will test 2 versions—with and without adjuvant—to decide which would continue to phase 2. The estimated number of participants is 368, and the trial currently lists 2 trial sites in Perth (Western Australia) only. (Contact details here.)

SK Bioscience is the South Korean pharmaceutical company that rolled out SKYCovione internationally. SKYCovione is a protein subunit vaccine developed originally by the University of Washington. (Records on that vaccine, originally called GBP510, here.) After earlier preclinical testing of GBP510 to assess its potential against other sarbecoviruses, the company began work on the sarbecovirus-targeted version now heading into trial (called GBP511).

This vaccine could have an advantage down the line compared to some other next generation vaccines because of the amount of data and use of its original formulation. A major 2023 workshop including drug regulators discussed the challenges faced by next generation Covid vaccines. Regulators supported reliance of immunobridging data more for existing vaccine platforms than novel ones. That means manufacturers don’t have to do very large phase 3 trials, because they can submit data on signs of immune response rather than clinical outcomes. Immunobridging “was considered an important potential tool for bridging data gaps relevant to pan-SARS-CoV-2 vaccine development and regulatory approval.” This vaccine was based on a technique that has previously been used for influenza vaccine.

SKYCovione—marketed as SKYCovion in the UK—was a late arrival to Covid vaccines, and was ultimately discontinued. By the time it arrived, variant-adapted versions of the mRNA vaccines were available, and there wasn’t enough demand for a new vaccine based on the original SARS-CoV-2. It gained approvals in South Korea and the UK, and was the 12th Covid vaccine to be granted WHO emergency use listing.

Preclinical reports

• Intranasal viral vector vaccine from the Weatherall Institute of Molecular Medicine at the University of Oxford (UK): This is the first report for this vaccine. It is based on an influenza viral vector, and aims to protect against betacoronaviruses. The developers created 2 versions, a membrane-anchored form of the spike protein (S-RBD-TM) and a secreted form (S-RBD-Sec). The S-RBD-TM version elicited stronger responses in mice. They then created a version based on another coronavirus, and used both in a prime-boost regimen, compared to 2 doses of the version based on SARS-CoV-2 only. The regimen based on 2 coronaviruses induced more signs of immune response to coronaviruses not included in the vaccines.

• Virus-like protein vaccine from the University of Wisconsin-Madison (USA): This is the 6th preclinical report for this pancoronavirus vaccine development program. (All records here.) The developers generated vaccines based on S2 antigens from sarbecoviruses (Clades 2 and 3), and tested them in mice. Animals vaccinated with either vaccine were protected in challenge tests with SARS-CoV-2, Omicron (XBB), and a SARS-like bat coronavirus W1V1.

• Protein subunit vaccine from the Indian Institute of Science (India): This is the first report for this vaccine. It was developed based on proteins from 5 sarbecoviruses, including the original SARS. The vaccine was tested in mice, including some pre-vaccinated against Covid. The vaccine induced signs of immune response to a range of sarbecoviruses, and a freeze-dried version remained stable during a 15-day test.

Pancoronavirus vaccine overview

A table below this post keeps track of vaccines I’ve added to this category so far that have publicly available preclinical results. Of these vaccines, 8 have reached phase 1 clinical trials, and 1 has reached phase 2. Some of them have results, and they are marked *:

• * CoronaTcP (Gylden Pharma, UK/US) – protein subunit. (Note: This vaccine was previously called PepGNP-SARSCov2, and the manufacturer was previously called Emergex.)

• DIOSynVax (Cambridge University spin-off, UK) – mRNA.
  
  
• Duke University (USA) – protein subunit.
  
  
• INSERM/Ennodc (formerly LinkInVax) (France) – protein subunit.
  
  
• Osivax (France) – protein subunit.
  
  
• SK Bioscience (South Korea) – protein subunit.
  

• * VBI Vaccines (Canada) – eVLP. [This company announced bankruptcy in late 2024.]

• * Walter Reed Army Institute of Research (WRAIR, USA) – protein subunit.

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Addendum 1: List of authorized next generation Covid vaccines (with countries)

There are 7 next-generation Covid vaccines authorized in 7 countries. Only one has been approved by drug regulatory agencies designated stringent, or listed, by WHO – in bold; the others have all been approved in at least one country by a drug regulator WHO has listed with transitional status for vaccines. I’ve listed the vaccines in 2 categories, in order of date of first authorization (or initial approval).

Mucosal:

• Razi-Cov Pars (Iran), intranasal protein subunit vaccine: Iran (October 2021).
• Sputnik (Russia), intranasal viral vector vaccine: Russia (April 2022).
• Convidecia (China), inhaled viral vector vaccine: China (September 2022), Morocco (November 2022), Indonesia (March 2023).
• iNCOVACC (USA/India), intranasal viral vector vaccine: India (September 2022).
• Pneucolin (China), intranasal viral vector vaccine: China (December 2022).

Durable or “variant-proof”:

• Gemcovac (India), self-amplifying mRNA vaccine: India (June 2022).

• Kostaive (LUNAR-COV19) (USA), self-amplifying mRNA vaccine: Japan (November 2023), European Union (February 2025).

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Addendum 2: Definitions of vaccine types

• Mucosal vaccines: These enter the body the way the virus does – through mucosal tissues. It’s hoped that provides defence against infection. They can be administered via different routes – squirts or drops in the nose, inhaled through the mouth through a nebulizer (similar to an asthma medication), or in tablet, capsule, or sublingual form.

• Pan-SARS-CoV-2 or “variant-proof” vaccines: These aim to provide protection against any variant of the coronavirus that causes Covid-19.
  

• Pancoronavirus vaccines aim to protect against coronaviruses more broadly – sometimes called “universal coronavirus vaccine.” These vaccines can be targeted to:
  
  – the “subgroup” the 2 SARS viruses came from (the sarbecovirus subgenus),
  
  – coronaviruses from the next level up (the genus, betacoronavirus, which includes MERS as well as the sarbecoviruses), or
  
  – up to the whole coronavirus family, which has 4 genuses, including betacoronavirus and alphacoronavirus (with more common cold viruses).
  
  I classify a vaccine as a pancoronavirus one when the developers are explicitly targeting coronaviruses more broadly than SARS-CoV-2 in the design of the vaccine, and have tested for signs of response to non-SARS-CoV-2 coronavirus(es) (or clearly plan to).

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You can keep up with my work at my newsletter, Living With Evidence. And I’m active on Mastodon: @hildabast@mastodon.online and less so on BlueSky (hildabast.bsky.social).

ICYMI:

• An introduction to self-amplifying mRNA, plus my compendium on getting ready for more mRNA fear-mongering.
• Check out my May 2024 post, “When will we get a sterilizing Covid vaccine?”

~~~~

For details on how I track Covid vaccine progress, see my background post. Notes on my collection of studies are here. The collection is in a public Zotero library you can dig into here.

Previous update posts specifically on next generation Covid vaccines prior to this monthly series (beginning May 2023):

1. Mucosal vaccines (March 2022)
2. Pan-SARS-Cov-2 and pancoronavirus (July 2022)
3. Mucosal vaccines (July 2022)
4. Mucosal vaccines (September 2022)
5. Mucosal vaccines (April 2023)
6. Pancoronavirus vaccines (April 2023)

All my posts on Covid vaccines, beginning from March 2020, are tagged here.

All previous Covid-19 posts at Absolutely Maybe

My posts at The Atlantic and at WIRED.

Disclosures: My interest in Covid-19 vaccine trials began as a person worried about the virus, as my son was immunocompromised: I have no financial or professional interest in the vaccines. I have worked for an institute of the NIH in the past, but not one working on vaccines. More about me.

The cartoon is my own (CC BY-NC-ND license). (More cartoons at Statistically Funny.)

Postscript: US Project NextGen funded trials

Mucosal vaccines:

• Phase 1 for MPV/S-2P, the intranasal viral vector vaccine developed by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). This trial for 60 participants began recruiting in July 2024, and finished recruiting by early 2025.

• Phase 2b for the oral viral vector vaccine from Vaxart (trial start announced at the end of September 2024; trial registration here) – further recruitment for this trial was cancelled, though followup will be completed for the participants already dosed (around 5,000). The company has a deal with Dynavax to take the vaccine forward, depending on phase 2 trials.
• Phase 2b for the intranasal viral vector vaccine from CyanVac/Blue Lake Biotech (trial started in December 2024, trial registration here) – no recent news on this trial.

• 2 trials are apparently not going ahead: A Phase 2b (“mini-efficacy”) for the intranasal protein subunit vaccine from Castlevax – this grant was paused and may be terminated. Castlevax has since registered a far smaller phase 2a trial with some similar methodological features. Another for the intranasal live attenuated vaccine from Codagenix had not apparently started.

Durable or “variant-proof” vaccines:

• Phase 1 for STX from Capricor (trial began dosing participants in August 2025). Capricor announced in November 2025 that the trial is ongoing.

• Phase 1 for TNX-1800 from Tonix (aiming for lifelong immunity) (planned to go into clinical trial in 2024 – no recent news);

• Funding was terminated for the Phase 2b (“mini-efficacy”) trial for GeoVax (viral vector vaccine).

Note: Gritstone Bio was originally in line for a phase 2b trial for their self-amplifying mRNA vaccine. However, the company declared bankruptcy and in January 2025, their assets were sold.

Pancoronavirus vaccines – presumed canceled:

• CoronaTcP (Gylden Pharma, UK/US) – protein subunit.
• Unnamed (PopVax, India) – mRNA.

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