Another Approval and More NextGen Covid Vax News (Update No 37)

This month, Arcturus’ self-amplifying mRNA vaccine was approved for use in the UK. There were also new clinical trial results for another vaccine aiming to be variant-proof—an mRNA vaccine from AstraZeneca—and another clinical trial for a mucosal vaccine starting in Finland. And there are 11 reports of preclinical results, including for 2 intranasal pancoronavirus vaccines.

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. In addition, there are some tables tracking vaccines on my personal website.

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?”

• 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

Last month, I reported that Rokote in Finland were planning a new phase 1 trial for a new formulation of their nasal spray vaccine, after completing a phase 1 trial of the original version of this viral vector vaccine. The company’s CEO reported that preclinical studies had indicated that the new formulation was more effective, though these results have not been published. That new trial has now been registered, though with very few details. The start of recruitment in Finland planned for this month.

There were 4 preclinical reports for mucosal vaccines this month, including 2 pancoronavirus vaccines from vaccine developers in Hong Kong and Singapore. Both of those are included in the pancoronavirus section below.

Preclinical reports

• Intranasal protein subunit vaccine from the Naval Medical University Shanghai (China): This is the first report for this vaccine. The developers tested an unadjuvanted version as well as one with lentinan as an adjuvant to increase mucosal effectiveness. (Lentinan is a substance used in some medicines as an immunomodulator.) The vaccine was tested in injected and intranasal versions in mice. The developers also reported on Covid challenge tests (with SARS-CoV-2, and Omicron variants BA.5 or EG.5) comparing unadjuvanted and lentinan-containing intranasal versions, with a control group. Both versions protected mice from SARS-CoV-2. In the Omicron challenge test, all control mice died, the unadjuvanted vaccine provided some protection though some animals still died, and no mice died in the lentinan group.

• Intranasal protein subunit vaccine from the University of Helsinki (Finland): This is the first report for this vaccine. Several regimens were tested in mice, including 2 doses of injected or intranasal vaccine, or combinations of the methods of administration. The developers report that a prime injection dose followed by intranasal boost provided superior signs of immune response.

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 are some phase 1 trial results and 3 preclinical reports for vaccines in this category. As well, there is news for 2 others: Authorization for Arcturus’ self-amplifying mRNA vaccine in the UK, and some information on plans for the GeoVax vaccine.

UK approval for Arcturus’ self-amplifying mRNA vaccine

This vaccine had previously been authorized in Japan and the European, with the generic name Zapomeran and the trade name Kostaive. The UK’s drug regulator announced approval of Kostaive this month. At the time of writing, their assessment report was not yet published, but product leaflets were.

The vaccine has been slow to roll out after authorization, so it’s not clear when it will be available in the UK. You can read more about this type of mRNA in my post, An introduction to self-amplifying mRNA. The most data on the vaccine is included in the European Medicines Agency assessment report. (All records in my collection for this vaccine here.)

Phase 1 trial results for mRNA-VLP vaccine from AstraZeneca

This vaccine was originally based on a component of the Delta variant, fused to Helicobacter pylori (H. pylori) ferritin protein. The phase 1 trial ran in the US, testing 5 or 10 μg doses of 2 versions of the vaccine with the standard 30 μg dose of the BNT/Pfizer mRNA vaccine used in a control group. One of the versions was based on Omicron XBB.1.5 (AZD6563), and the other was based on Omicron BA.4/5 (AZD9838). The BNT/Pfizer vaccine was the version updated for XBB.1.5.

The trial was originally registered anticipating 90 participants, but ultimately included 243 participants according to the trial register entry. Some interim results for 242 participants in this trial up to 180 days have been published in an abstract from the 2025 ID Week in the US. The version named AZD6563 had a lower rate of adverse effects and better immune response than the other (AZD9838). The 10 μg dose of AZD6563 showed similar immunogenicity to the 30 μg dose of the BNT/Pfizer vaccine up to the 6 months reported so far.

There is a preclinical report for this vaccine in my collection, describing results in primates and non-primates.

GeoVax seeking support to advance viral vector vaccine for people with immunocompromise

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 and other high risk people who need better protection from Covid. The vaccine is in several clinical trials, and has had encouraging results compared to mRNA vaccine. (All records for this vaccine here.) The vaccine had one of the US Project NextGen grants that were canceled by the new regime.

A company report on plans for 2026 discusses plans for continuing to advance the vaccine, but does not include a phase 3 trial. However, “future regulatory and partnering discussions” are mentioned, so perhaps they are actively seeking support for that major undertaking.

Preclinical reports

• Virus-like particle vaccine from the University of Melbourne (Australia): This is the third report for this vaccine. (All records here.) It was tested in mice, and developers report signs of immune response to a range of Covid variants. They also described results of challenge tests, with the vaccine providing protection against the variants tested (Beta, Delta and Omicron BA.5).

• mRNA vaccine from the Vaccine Alliance Aotearoa New Zealand (VAANZ) (New Zealand): This is the first report for this vaccine. The vaccine includes components of Omicron and Delta variants, and it was tested in mice. The developers reported that vaccinated animals showed signs of response to Omicron, Delta, and the original SARS. (I didn’t include this under pancoronavirus vaccine, however, as the developers do not explicitly state that aim.)

• Protein subunit vaccine from the National Research Council Canada, Human Health Therapeutics Research Centre (Canada): This new report is the sixth for this vaccine. (All records here.) The developers report on tests in mice comparing 2 doses of their vaccine in mice, with either 2 doses of mRNA vaccine or a combination of a dose of each vaccine (heterologous vaccination). They concluded that 2 doses of mRNA vaccine were superior to either 2 doses of protein subunit vaccine or protein subunit vaccine first. However, mRNA vaccine followed by protein subunit vaccine boost provided superior signs of immune response.

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 several drug regulatory authorities 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 authorized for Europe in February 2025, and in the UK in January 2026.

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Pancoronavirus vaccine news

This month, there are 2 preclinical reports from Asia for mucosal vaccines in this category, as well as 4 reports for 3 other pancoronavirus vaccines in the US.

Preclinical reports for mucosal pancoronavirus vaccines

• Intranasal protein subunit vaccine from the National University of Singapore (Singapore): This new report is the third in my collection for this vaccine. (All records here.) The vaccine includes components from an Omicron variant (XBB.1.5) and the original SARS. Previous versions had been based on one or the other, resulting in limited breadth of immune response. The combination, called Clec9A^OMNI, was tested as a booster in BNT/Pfizer-vaccinated mice, compared with BNT/Pfizer booster.
  
  The mice boosted with Clec9A^OMNI showed immune responses to versions of SARS-CoV-2 and original SARS, whereas the mRNA-only vaccinated mice showed immune responses only to SARS-CoV-2—and the responses were shorter lived. Results were also superior in a challenge tests with Omicron BA.1. Intranasal boosting provided protection in both the upper and lower airways.

• Intranasal live attenuated vaccine from the University of Hong Kong (China): This is the first report for a vaccine called cb1. It was tested as a booster in mice vaccinated with mRNA vaccines or CoronaVac, with control groups vaccinated with boosters of the same primary vaccine. The mice vaccinated with cb1 showed immune responses for a range of Covid variants. Tests for immune responses to a range of other coronaviruses also showed wider signs of response in the cb1-vaccinated mice, but not to all of them. In addition, the live attenuated vaccine protected mice in challenge tests with SARS-CoV-2, the original SARS, and a mouse-adapted version of another sarbecovirus that infects humans (hCoV-OC43).
  
  The developers also report on transmission tests in hamsters. Mock-vaccinated and cb1-vaccinated animals were challenged with SARS-CoV-2. Hamsters co-housed with those mock-vaccinated hamsters showed signs of infection, while those co-housed with cb1-vaccinated animals did not.

Other preclinical reports

• Nanoparticle vaccine delivered with mRNA from Caltech (USA): This new report is the eighth for this vaccine, called Mosaic8b. Caltech is partnering with Ingenza from the UK to further develop this vaccine. Previously, the vaccine has been tested in protein-based versions, and this is the first report for one developed with mRNA. (All records here.) This vaccine is difficult to manufacture as it is a mosaic of 8 components, either individually or in 2 sets of 4. The developers aimed to develop a version based on mRNA to overcome the difficulties of scaling up manufacture of the vaccine. The developers describe the methods used for developing the mRNA version, and results of testing it in mice. They report that the mRNA version had comparable results to the previous protein-based vaccine.

• mRNA vaccine from the State University of Georgia and the University of Iowa (USA): This new report is the fourth for this vaccine. (All records here.) This vaccine includes components from 2 Omicron variants (EG.5 and KP.3). Mice vaccinated with it showed signs of immune response to a broad range of Covid variants. The developers also report on a challenge test with Omicron KP.3, in which mice were protected from illness and had lower levels of virus than control animals.

• Protein subunit vaccine from the Scripps Research Institute (USA): I added 2 preclinical reports for this vaccine—a new one, and one from 2022 that I had missed, bringing the total for this vaccine to 3 reports (here). In the new report, the developers describe various tests, including Covid challenge tests in mice, and using a regimen of prime vaccination with a version of vaccine based on SARS-CoV-2 with a boost from a version based on MERS and other betacoronavirus that was tested in macaques. They concluded that while the vaccine could induce immune responses, but there were barriers to adequate B cell immunity.

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), UK (January 2026).

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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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