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A Big Month for Progress on Mucosal Covid Vaccination (NextGen Vax Update 33)

A smug nasal spray is being sniffed, while looking disdainfully at a coronavirus. (Cartoon by Hilda Bastian.)
Image credit
Cartoon by Hilda Bastian, CC BY-NC-ND 4.0

It was a bumper month for mucosal Covid vaccines. There were some phase 1 results for an intranasal vaccine from China: It’s the 35th mucosal Covid vaccine in clinical trials. There’s also news from Spain: Researchers from the National Center of Biotechnology (CNB-CSIC) have developed an intranasal self-amplifying mRNA vaccine based on several parts of the SARS-CoV-2 virus. They report that it was able to block transmission in mice. That’s one of 9 preclinical reports this month, mostly for mucosal and “variant-proof” vaccines. And there’s more phase 3 clinical trial results for the self-amplifying vaccine from Arcturus. There’s news, too, on an important early milestone in the program to fast-track mucosal Covid vaccine development with human challenge studies. Unfortunately, though, there’s more bad news for mucosal vaccine trial funding from the US.

Before we get to all that, you might also be interested in some pandemic preparedness news from Singapore this month. It’s the new international headquarters for Hilleman Laboratories, a joint non-profit venture funded by the Wellcome philanthropic foundation and Merck. A news article describes a new major manufacturing facility that would be able to quickly respond to a new pandemic, developing and manufacturing vaccine for Singapore’s population of 6 million. In the meantime, the facility will work on the high-commercial risk stage of early vaccine development for infectious diseases, developing vaccines that are specifically designed for low-income countries. Although it’s not about Covid vaccines, the article is a fascinating look at the challenges of vaccine development.

Back to Covid 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.

ICYMI:

  • Check out my May 2024 post, “When will we get a sterilizing Covid vaccine?”

Mucosal vaccine news

This month, there is a phase 1 trial report for an intranasal viral vector vaccine from China along with preclinical results for it: It is the 35th mucosal vaccine I’ve found in clinical trial. There are also preclinical reports for 5 mucosal vaccines, including an intranasal self-amplifying mRNA vaccine from Spain. There is an update on a Covid human challenge study in the UK – and more bad news from the US.

Phase 1 trial and preclinical results for intranasal viral vector vaccine from Sichuan University (China)

This is the first report I’ve seen for this vaccine (called WSK-V106C), combining preclinical and phase 1 trial results. It’s an Adenovirus 5 viral vector vaccine, with a protein subunit from the XBB.1.5 Omicron variant. The preclinical results showed it protected mice in a challenge test with the XBB.1.16 variant, and prevented transmission in a co-caging test in vaccinated and unvaccinated hamsters with the XBB.1.5 variant.

The phase 1 trial of WSK-V106C as a booster included 70 participants who had previously received 2 or 3 doses of other vaccines. The developers report that the participants were unlikely to have been exposed to XBB Omicron prior to this booster. There were 2 groups, receiving a 2-dose course of either low or higher dosage, 2 weeks apart. The rate of reported adverse reactions was low (less than 10%), with no severe or serious adverse events. The developers reported robust signs of immune response, both mucosal and systemic.

Other preclinical results for mucosal vaccines

  • Intranasal self-amplifying mRNA vaccine from the National Center of Biotechnology (CNB-CSIC) (Spain): This is the first report for this vaccine, which combines potentially more durable mRNA with mucosal protection. The developers had previously developed a MERS vaccine. They reported that the Covid vaccine maintained production of RNA of several proteins for a few days in mice. (More on self-amplifying mRNA in my introduction post here.) Vaccination induced high levels of a range of signs of mucosal and systemic immunity. As part of their safety assessment, the developers compared inflammatory responses in vaccinated mice with those in mice infected with Covid. In addition, they found no replicating RNA in the nose or lungs of mice at 2, 4, and 6 days after vaccination.

    The developers report on the results of a challenge test in mice, comparing groups of mice receiving 1 or 2 intranasal doses of vaccine with an unvaccinated group. All unvaccinated mice died, as did half of those receiving 1 dose, while none of those protected by 2 doses died. No infectious virus was detected in the noses or lungs of vaccinated mice at 4 and 6 days post-challenge, they showed no signs of illness, and no signs of Covid infection.

    The report also describes the development of a version of the vaccine updated for the XBB.1.5 Omicron variant, to assess the engineering of updating the vaccine if needed in response to virus evolution.

    There is no discussion of plans for this vaccine. However, the Center had collaborated with Spanish pharmaceutical manufacturer Biofabri on a previous Covid vaccine, and Biofabri has other mRNA vaccines in their pipeline.
  • Intranasal protein subunit vaccine from the University of Sydney (Australia): This is the second preclinical report for this vaccine. (The first is here.) The vaccine includes Pam2Cys adjuvant. As well as reporting on signs of immunity after a 3-dose intranasal course of vaccination or 2 injections plus an intranasal boost in mice, the developers report on a challenge test with the Delta variant. Both courses of vaccination completely protected the mice from signs of infection and illness. A control group receiving only Pam2Cys was not protected.
  • Bivalent intranasal viral vector vaccine for SARS-CoV-2 (live attenuated) and RSV from Ohio State University (USA): This vaccine uses live attenuated SARS-CoV-2 (Omicron JN.1) as the viral vector for an RSV vaccine, aiming to protect against both diseases. This is the first preclinical report for the vaccine. The developers tested 2 versions of the vaccine, finding one was not sufficiently immunizing. However, one fully protected hamsters in challenges for both viruses after a single dose.
  • Intranasal virus-like vesicle vaccine from Yale University (USA): This is the first preclinical report for this vaccine. In tests in mice with an injection followed by an intranasal booster, immune responses were similar to those of the BNT-Pfizer mRNA vaccine.

Covid human challenge study update

The international MUSiCC Project aims to dramatically speed up development of mucosal vaccines for Covid. The consortium, led by Imperial College London, will do this by running human challenge studies to test vaccines. That involves trying to infect volunteers under controlled conditions. That way, you can find out very quickly, with very few participants, whether or not a vaccine protects people from infection. (If you’re concerned about the risks of this, I wrote my thoughts on that here.)

The first step is developing a version or versions of SARS-CoV-2 infectious enough to enable a vaccine trial, with the lowest risks. There are 3 relevant studies tackling this. The first tested versions of the Delta variant, in 46 people in the UK. It is called COVHIC002, completed in June 2025. The quarantine period for the final participants had ended in June 2024. Results for this study haven’t been published yet. (Results of COVHIC001, which tested the original version of SARS-CoV-2, have been published.)

The second study began in London in December 2024. It’s called COVCHIM-02, and it is testing a version of Omicron BA.5 in 90 participants. Participants are still being recruited for this study in London and Oxford.

The third study is Sing-COV, recruiting 20 participants in Singapore. It is testing the same version of the Delta variant used in COVHIC002. The study is being run by Singapore’s National Centre for Infectious Diseases. In March 2025, they reported that the first group of 5 participants had received the dose of Delta (via nose drops). They hoped to finish recruiting in September or October, and to begin recruiting for an Omicron study this year. (People interested in participating in Sing-COV can register their interest here.)

Project NextGen cancellation: Vaxart

The on-again off-again Project NextGen funding for Vaxart’s Phase 2b “mini efficacy” trial is now definitely off. A formal filing by the company confirms that although there had been a new agreement in June, they received a stop work order in August. The trial will continue for the approximately 5,000 people already dosed in the placebo-controlled trial for the oral 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. However, none have been authorized by a drug regulatory agency designated stringent, or listed, by WHO.
  • 35 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, 5 have reached phase 2 trials, and another 2 have reached phase 2/3 trial.

US Project NextGen-funded trials in this category:

  • 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); and
  • 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. Another for the intranasal live attenuated vaccine from Codagenix has not apparently started.

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Durable or “variant-proof” vaccines

This month, there was another report of phase 3 trial results for the Arcturus vaccine (trade name Kostaive). There were also 4 preclinical reports in this category, including the intranasal self-amplifying mRNA vaccine from Spain discussed above.

More phase 3 trial results for the self-amplifying mRNA vaccine from Arcturus (USA)

There have been several phase 3 trials for this vaccine, which has been authorized in Japan and Europe. I summarized the findings of the European Medicines Agency assessment in my post last February. They concluded that the protection this vaccine offers is similar to that of the BNT/Pfizer mRNA vaccine, but with more durability.

This new report of immunogenicity and safety is for a phase 3 trial assessing an updated version of the vaccine (called ARCT-2303), with or without co-administration with quadrivalent influenza vaccine. There were 1,499 participants in Australia and the Philippines, with over 60% female. The trial included 197 people aged 65 or older.

In a comparison with historical data on the currently authorized version of the vaccine, immune responses to Omicron XBB.1.5.6 were superior for the updated vaccine. The frequency of adverse reactions was not affected by co-administration of influenza vaccine. The trialists concluded that the 2 vaccines could be co-administered without impacting the safety or immunogenicity of either vaccine.

The trial register record for this latest trial is here. All records in my collection for this vaccine are here.

Preclinical results for other “variant-proof” vaccines

  • DNA vaccine from Institut Pasteur de São Paulo (Brazil): This is the first preclinical report for this vaccine. The vaccine is T-cell based, delivered with an electroporation device (which delivers electrical impulses along with the injection). It was tested in a 2-dose course in mice, including a Covid challenge test (B.1.1.28). The developers reported that the vaccinated mice had reduced clinical symptoms and viral loads.
  • Circular RNA vaccine from the University of Pennsylvania (USA): This is the first preclinical report for this vaccine. Circular RNA vaccine has a different structure to mRNA vaccine, is at an early stage of development. This was tested in mice with a single or 2-dose course of a version of the vaccine based on the Delta variant, with comparison groups with a 2-dose course of mRNA vaccine. Protein production levels were generally lower for the circular mRNA.
  • mRNA vaccine from Wuhan University (China): This is the first preclinical report for this vaccine, which aims to restrict the impact of the vaccine on organs unrelated to immunity to improve safety. It was tested in mice who were dosed with either their vaccine (WNP) or regular mRNA, or a placebo. The report describes results of a challenge test with Omicron BA.1 and XBB.1.5. The developers concluded that their vaccine had a more restricted impact, with similar 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 one vaccine in this category that has been authorized by a drug regulatory authority designated by WHO has stringent, or listed – and tested against an mRNA vaccine:

  • 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.

US Project NextGen-funded trials in this category:

  • Phase 1 for STX from Capricor (trial began dosing participants in August 2025).
  • 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.

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Pancoronavirus vaccine news

This month there was one preclinical report for a new vaccine in this category, from Australia. There was also a modeling study of the potential impact of a broadly protective sarbecovirus vaccine if there is another coronavirus similar to the original SARS. While it would depend on its effectiveness and extent of availability, a vaccine could slow an epidemic’s growth, the authors concluded, “buying valuable time for health-system response and virus-specific vaccine development.” If an effective pancorovirus vaccine had been widely available when Covid-19 emerged, they calculated that a substantial proportion of the mortality in the first year could theoretically have been prevented.

Preclinical report for a protein subunit vaccine from the Burnet Institute (Australia):

This is the first report I’ve seen for this vaccine. It is based on protein components from 3 types of sarbecovirus, with an adjuvant. The vaccine remained stable without refrigeration in soluble form (tested after 6 months). The developers also demonstrated that the trivalent immunogen could also be applied to an mRNA platform.

The report first describes tests on a SARS-CoV-2 version of the vaccine in mice, which was able to protect the animals in a challenge test. The trivalent sarbecovirus vaccine was also tested in mice, with 3 comparison groups (receiving saline or monovalent vaccines). Mice receiving the trivalent vaccine had higher rates of antibodies to several SARS-CoV-2 variants as well as several sarbecoviruses.

This group is also working on a MERS vaccine: More on their betacoronavirus program here.

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, 7 have reached phase 1 clinical trials, and 1 has reached phase 2, with some results for 3 of them 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.

  • * VBI Vaccines (Canada) – eVLP. [This company announced bankruptcy in late 2024.]
  • * Walter Reed Army Institute of Research (WRAIR, USA) – protein subunit.

US Project NextGen-funded trials in this category – no recent news on the funding for either:

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

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

There are now 7 next-generation Covid vaccines authorized in 7 countries. Only one has been authorized or approved by drug regulatory agencies designated stringent, or listed, by WHO – in bold. Authorization is pending in the European Union. 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).

Self-amplifying mRNA:

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Addendum 2: Table of mucosal vaccines in clinical trials

Indicates new entry since previous update post.

Note: Where there is a link to “All records” for a vaccine, that’s in my public Zotero collection for the vaccine, and it may include non-mucosal studies for that vaccine. Notes on that collection are here. For details on how I track Covid vaccine progress to maintain that collection, see my background post.

Vaccine, type, manufacturerMucosal version(s)Phase 1 to 2 clinical trialsPhase 3+ trial(s)Phase 3+ efficacy or immunogenicity results
ACM-001
Protein subunit

ACM Biolabs (Singapore/Switzerland)
(All records)
Intranasal.Phase 1.
Results (press release only)
Ad5-nCoV (Convidecia Air)
Viral vector (adenovirus)

CanSino (China)
(All records)
Inhaled through the mouth using a nebulizer.Phase 1. Results.

Phase 1/2. Results (plus second later preprint).

Phase 1/2.
Results.

Phase 2 (aged 6-17 years).

Booster adapted for variant.
10,420 people in China (Phase 3).
Results.

1,350 people (Phase 3).

540 people, in Malaysia (Phase 3).
Results.

904 people in China (Phase 4).
Results.

360 people (Phase 4).

451 people (Phase 4). Results.

10,000 people in China (Phase 4). Results for 4,089 in the Ad5-nCoV arms. (Previously in preprint.)

450 people in China (Phase 4).
Results.
904 people: Comparison after 2-dose course of inactivated vax: Convidecia injection vs inhaled, protein subunit, or CoronaVac booster (Phase 4 results). Both injected & inhaled Convidecia had stronger impact on signs of immunity than the others; response after inhaled version was slower but longer-lasting than injected (which peaked then declined from day 14), better for Omicron though not as good for original virus. No measure of mucosal immunity used.

539 people (Malaysia): Signs of serum immune response were lower for inhaled Convidecia than for injected BNT/Pfizer vax at 14 days, but grew for Convidecia to similar levels. Mucosal immune response (SIgA) was greater for Convidecia; the rate of adverse reactions was lower.

451 people: Comparison of different versions adapted for variant, including a bivalent version. Booster of inhaled Convidecia after previous vaccination with inactivated vaccine. Signs of immune response to Omicron were higher for the bivalent vaccine, though lower for the original SARS-CoV-2 strain.

4,089 people, plus a 2,008 un-randomized unboosted control group:
This trial tested the original vax during Omicron, with either an injected or inhaled booster. There wasn’t a significant difference between them, though the injected version fell below their ineffectiveness threshold and the inhaled one reached effectiveness despite having a smaller dose of vaccine.

450 people: Convidecia showed less antibodies and higher mucosal signs of immunity than an mRNA vaccine. Waning at 6 months was similar for both.
Ad5-S
Viral vector (adenovirus)

State Key Laboratory for Infectious Disease/Guangzhou Enbao Biomedical Technology Co (China)
(All records)

Intranasal.Infection prevention study.
AdCOVID
Viral vector (adenovirus)

AltImmune (USA)
(All records)
Intranasal.Phase 1Results – press release only.

Discontinued after phase 1.
AdS+N
Viral vector (adenovirus)

ImmunityBio (USA)
(All records)

Intranasal, oral capsule, or sublingual.Phase 1 (oral).

Phase 1 (sublingual).
AeroVax (Ad5-triCoV)
Viral vector (adenovirus)

McMaster University/Canadian Institutes of Health Research (Canada)
(All records)
Aerosol.Phase 1 (& ChAd-triCoV/Mac).
Results.

Phase 2.
Short protocol. Began enrolling in March 2025.
Avacc 10
Protein subunit

Intravacc (Netherlands)
(All records)
Intranasal.Phase 1.
Results (press release only)
bacTRL-Spike-1
Live attenuated

Symvivo (Canada)
(All records)
Oral.Phase 1.
BBV154 (iNCOVACC)
Viral vector (adenovirus)

Bharat Biotech (India)
(All records)

This vaccine is ChAd-SARS-CoV-2-S
Washington University in St Louis (USA)
(All records)

Intranasal.Phase 1.

Phase 2.

Small amount of data from these trials in the drug product information.

Phase 2/3.

Phase 2.
In India, 2-dose course of BBV154 vs 2-dose course of injected Covaxin inactivated vaccine (Phase 3 – and here).
Results (previously in preprint).

See also the drug product information.

875 people in India, booster trial (Phase 3). Results.
2,971 previously unvaxed people were assigned for the intranasal iNCOVACC, 161 for injected Covaxin. This trial did not aim to assess disease outcomes. It took place during the first Omicron wave.

Signs of immune response were higher for iNCOVACC than Covaxin.

Adverse events rate very low (5% local and 3% systemic) – lower than for comparison group.

875 previously vaxed people were boosted with iNCOVACC, Covaxin (inactivated vax) or Covishield (AstraZeneca viral vector vax). Not large enough to detect a difference in immune response. Lower rate of adverse reactions than Covishield.
B/​HPIV3/​S-6P
Viral vector (parainfluenza)

NIH’s National Institute of Allergy and Infectious Diseases (NIAID) (USA)
(All records)
Intranasal.Phase 1.
Fully recruited by early July 2024.
BV-AdCoV-1
Viral vector (adenovirus)

Wuhan BravoVax
(China)
(All records)
Inhaled through the mouth using a nebulizer.Phase 1.
ChAdOx1
Viral vector (adenovirus)

Oxford University (UK)
(This is the AstraZeneca vax)
(All records)
Intranasal.Phase 1.

Phase 1.

Results.
CoV2-OGEN1
Protein subunit

US Specialty Formulations/VaxForm (USA)
(All records)
Oral.Phase 1.
(Fully recruited, final dose in November 2022.)
Press release stating successful (without data) and progressing to phase 2 trial.
COVI-VAC
Live attenuated

Codagenix (USA, with the Serum Institute of India)
(All records)
Intranasal.
Phase 1.
Press release in 2021 stating successful (without data) and progressing to phase 2/3.
Preliminary results (conference abstract in 2021) and in a 2022 press release.
Results in 2023 (press release only).

Phase 1 (booster).
Phase 2/3, as part of the WHO Solidarity Trial for Vaccines in Mali, Colombia, Kenya, Philippines, Sierra Leone. Fully recruited by July 2024. (Protocol.)
CVXGA1-001
Viral vector (parainfluenza)

CyanVac/Blue Lake Biotech (USA)
(All records)
Intranasal.Phase 1.
Results (formerly in press release only).
Phase 2.
Results (press release only).
Phase 2b.
dNS1-RBD (Pneucolin)
Viral vector (influenza)

Beijing Wantai BioPharm (China)
(All records)
Intranasal.Phase 1.
Phase 2.
Joint results.
Phase 1 (age 3-17). Results.
30,990 participants in Colombia, Philippines, South Africa, Vietnam.
Results (previously in preprint.)

5,400 participants in Ghana (Phase 3).
Comparison of 2 doses of intranasal vaccine 14 days apart, with placebo control, during circulation of Omicron. Included >13,000 previously unvaccinated people.

Efficacy shown 90 days after 2nd dose. There was some decline at 180 days.

Efficacy against symptomatic Covid:
No previous vax: 55.2% (CI 13.8 to 76.7)
Inactivated: 38.2% (CI -49.2 to 74.4)
Viral vector: 39.9% (CI -16.7 to 69.1)
mRNA: 10.1% (CI -45.9 to 44.5)

Efficacy against severe Covid:
No previous vax: 66.7% (CI 8.3 to 87.9)
Inactivated: 54.6% (CI -47.3 to 86.0)
Viral vector: 50.0% (CI -6.8 to 76.6)
mRNA: 19.5% (CI -39.2 to 53.4)

Efficacy against hospitalization:
100% (CI -9.2 to 100)

Adverse events were very low – similar to placebo. Less than 8% of people had a runny and/or blocked nose or sore throat.
FINCoVac
Viral vector (adenovirus)

Rokote Laboratories (Finland)
Intranasal.Phase 1, 2nd registry record.
GAM-COVID-VAC (rAd26-S – Sputnik Light)
Viral vector (adenovirus)

Gamaleya Research Institute (Russia)
Intranasal.Phase 1/2.
7,000 participants in Russia (Phase 3 or phase 2/3 – not clear).
GLS-5301
DNA

GeneOne Life Science (South Korea)
Intranasal.Phase 1.
Results.
LVT001
Protein subunit

LovalTech (France)
Intranasal.Phase 1/2.
Mambisa
Protein subunit

Centre for Genetic Engineering & Biotechnology (CIGB) (Cuba)
(All records)
Intranasal drops.Phase 1/2.

Phase 1/2.
Results.

Phase 2.
MPV/S-2P
Viral vector (murine pneumonia)

National Institute of Allergy and Infectious Diseases (NIAID)
(USA)

(All records)
Intranasal drops.Phase 1.
MV-014-212
Viral vector
(RSV)

Meissa Vaccines (USA)
(All records)
Intranasal drops or spray. Phase 1.
Results (press release).
This vaccine is in limbo because of the company’s financial difficulties.
MVA-SARS-2ST
Viral vector (MVA)

German Centre for Infection Research (DZIF)/IDT Biologika
(All records)
Inhalation.Phase 1.
NB2155
Viral vector (Adenovirus 5)

Guangzhou Medical University/ Guangzhou National Laboratory
(All records)
Intranasal.Phase 1.
CVAX-01
Viral vector (Newcastle Disease Virus)

Castlevax/Icahn Mt Sinai
(All records)
Intranasal.Phase 1.
Results (press release).
Ad5-S-Omicron BA.1
Viral vector (Adenovirus 5)

Guangzhou Medical University/Guangzhou National Laboratory
(China)

(All records)
IntranasalPhase 1.
Results.
Patria (NDV-HXP-S/AVX-COVID-12-HEXAPRO)
Viral vector (Newcastle Disease Virus)

Laboratorio Avi-Mex (Mexico)
(All records on Patria, see also CVAX-01 for early development.)

Intranasal.Phase 1.
Results.

Phase 2.
Results.
(Previously available in preprint.)
Phase 2/3 for injected version only: Results. (Previously available in preprint.)
PRAK-03202
Protein subunit

Oravax (USA) [Oravax was established by OraMed (Israel) to develop this vaccine, using Premas Biotech’s PRAK-03202 and their oral vaccine technology]
(All records on oral PRAK-03202, and on intramuscular version)
Oral.Phase 1 (in South Africa).
Results (press release only).
Razi-Cov Pars
Protein subunit

Razi Vaccine & Serum Research Institute (Iran)
(All records)
Intranasal (third dose after 2 injections).Phase 1.
Results.

Phase 2.
Results.

Phase 1 to 2 (in 12-17 year-olds).

Phase 4 (Booster).
Results.

Phase 1 to 2 (in 5-17 year-olds).
41,128 people in Iran, comparing the 3-dose course to 2-dose inactivated Sinopharm Beijing vax, only partially randomized (Phase 3).
Results
(Previous media report for the first 24,000 participants.)
Phase 3:
The authors concluded Razi-Cov Pars was non-inferior to the inactivated vaccine, with similarly very low adverse events. However, the trial could not establish whether there was an advantage to an intranasal dose.

Phase 4:
Immunogenicity and safety study of intranasal booster in 195 people, placebo-controlled. Increased IgA and IgG anti-RBD in nasal mucosa, but not in serum and saliva.
SC-Ad6-1
Viral vector (adenovirus)

Moat Bio/Tetherex (USA)
(All records)
Intranasal and inhaled.Phase 1.
Trial expanded to add an inhaled version (from 130 to 190 people). Results so far briefly mentioned in press release.
SpikoGen
Protein subunit

Vaxine (Australia)
(All records on mucosal and on all forms.)

Oral/sublingual.Phase 1.
* WSK-V106C
Viral vector

Sichuan University (China)
(All records)
Intranasal.Phase 1.
Results.
(Unnamed)
Inactivated bacteria

DreamTec (Hong Kong)
(All records)
Oral.Phase 1.
Phase 1.
Phase 1.

Note: An article of preclinical results has been retracted over lack of ethics committee approval.
VXA-CoV2-1/VXA-CoV2-1.1-S
Viral vector
(adenovirus)

Vaxart (USA)
(All records)
Tablets.Phase 1.
Results.

Phase 2. (Started October 1, 2021.)
Results (press release).

Additional brief results in presentation.

Phase 2b. (Start announced September 30, 2024.)
* Initial group of 5,000 participants to proceed, but government funding for continued recruitment cancelled (August 2025).

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Addendum 3: Pancoronavirus vaccines with preclinical results

Developer
Country

Vaccine name
Type of:

Vaccine

Coronavirus
Preclinical resultsClinical trial status
Academia Sinica Taiwan
(Taiwan)

(Unnamed)
mRNA

All
Non-primate
Acuitas Therapeutics
(Canada)

(Unnamed)
mRNA

Sarbeco
Primate, non-primate
Baylor College of Medicine
(USA)

(Unnamed)
Protein subunit

Beta
Non-primate
Beijing University of Chemical Technology
(China)

(Unnamed)
Live attenuated pangolin coronavirus

All
Non-primate
Beth Israel Deaconess Medical Center
USA

RhAd52.CoV.Consv
Viral vector

Sarbeco
Non-primate
* Burnet Institute
Australia

Unnamed
SarbecoNon-primate
California Institute of Technology (Caltech), Ingenza
USA, UK

Mosaic-8b
Protein subunit

Beta
Non-primate

Non-primate

Primate, non-primate

Non-primate (previously in preprint)

Non-primate (previously in preprint)

Primate and non-primate

Non-primate
Charité Universitätsmedizin Berlin
Germany

NILV-PanCoVac
Viral vector

All
Non-primate (mucosal)
China Cuba Joint Innovation Center
China, Cuba

PanCoV1, PanCoV2
Protein subunit

Sarbeco
Non-primate (mucosal)

Non-primate (mucosal)

Non-primate (mucosal)

Non-primate
(mucosal)

Non-primate (previously in preprint) (mucosal)

Primate (mucosal)
Chinese Academy of Sciences Key Laboratory of Pathogen Microbiology and Immunology
China

Unnamed
Protein subunit

Sarbeco
Non-primate
Codiak
USA

exoVACC Pan Beta Coronavirus
Protein subunit

Beta
Article on development

Non-primate (conference slides)

Non-primate
(conference slides)
(This company began proceedings
in bankruptcy court. See news.)
DIOSynvax
UK

DIOS-CoVax/
pEVAC-PS
mRNA

Sarbeco
Non-primate

Non-primate

Non-primate (a different vaccine)
Phase 1 trial (incl. protocol).
(Up to 36 participants in the UK)
Began December 2021.
Fully recruited.
Expanded to another city – no trial register entry found.
Duke University
USA

Cov-RBD-scNP-001
Protein subunit

Beta
Primate

Primate, non-primate

Non-primate (previously in preprint)

Primate, non-primate
US government grant terminated in March 2025.

Phase 1 trial.
(Up to 51 people in the US)
Not yet recruiting.
Francis Crick Institute
UK

(Unnamed)
Protein subunit with DNA boost

All
Non-primate
Fudan University
China

HR1LS
Protein subunit

Sarbeco
Primate, non-primate

Primate

Primate

Non-primate
Georgia State University, University of Iowa
USA

SARS2-S (SARS-RBD)
mRNA

Sarbeco
Non-primate

Non-primate
Georgia State University
USA

Om-S-MERS-RBD
Protein subunit

All
Non-primate
Georgia State University
USA

(Unnamed)
Protein subunit

Sarbeco
Non-primate

Primate, non-primate

Non-primate
Guangdong Pharmaceutical University
China

(Unnamed)
Protein subunit

All
Non-primate
Gylden Pharma
(formerly Emergex)
UK/USA

CoronaTcP
Protein subunit

Beta
Phase 1 trial
(26 participants in Switzerland)
Results. (Formerly
preprint)

Phase 1/2 trial
(Up to 110 participants in the Philippines)
(Not yet recruiting)
Korea Research Institute of Bioscience and Biotechnology
South Korea

(Unnamed)
Protein subunit

Sarbeco
Non-primate
INSERM Vaccine Research Institute/Ennodc (formerly LinKinVax)
France

EDC.PanCov (CD40.CoV2/RBDv)
Protein subunit

Sarbeco
Non-primate

Primate, non-primate

Primate

Non-primate (conference poster)

Non-primate
Phase 1/2 trial
(Up to 240 participants in France)
Booster trial; began recruiting in May 2024.
Johns Hopkins University
USA

Unnamed
Viral vector

Sarbeco
Primate, non-primate
Mynvax Private
India

Unnamed
Protein subunit

Sarbeco
Non-primate
National University of Singapore
Singapore

Clec9A-RBD
Protein subunit

Sarbeco
Osivax
France

OVX033
Protein subunit

Sarbeco
Non-primatePhase 1 trial
(48 participants in France)
First participant vaccinated in February 2024.
Fully recruited in June 2024.
Oxford University
UK

ChAdOx1.COVconsv12
Viral vector

Sarbeco
Non-primate
Pennsylvania State University
USA

(Unnamed)
Protein subunit

All
Non-primate
Scripps Research Institute
USA

(Unnamed)
Protein subunit

Beta


Non-primate
Shanghai Public Health Clinical Center and Institutes of Biomedical Sciences, Fudan University
China

rTTV-RBD-HA2
Viral vector

Beta (plus influenza)
Non-primate
(mucosal)
SK Bioscience/ Uni of Washington/Uni of North Carolina at Chapel Hill
South Korea, USA

GBP511
Protein subunit

Sarbeco
Primate, non-primate (testing Covid vaccine GBP510 against other sarbecoviruses)
More on plans for adapting this vaccine – GBP510 authorized as SKYCovione. See the University of Washington research listed below in this table.
Stanford University/DXVX
USA/South Korea

DX-DRG-B05
Virus-like particle

Beta
Non-primate

Primate
Erratum (correction to legend in a figure).

Non-primate

Non-primate (previously preprint)
Phase 1 clinical trials completed in the US (registered here) and South Africa (registered here), and planning underway for phase 2 trials in 2026 in South Korea, elsewhere in Asia, and the US.
State Key Laboratory of Respiratory Disease Guangzhou Medical University
China

(Unnamed)
Protein subunit

Sarbeco
Primate and non-primate
Sun Yat-Sen University
China

FP-HR5-NP
Protein subunit

Sarbeco
Non-primate
(mucosal)

Non-primate (mucosal)
Sun Yat-Sen University/Guangzhou Medical University
China

3Rs-NC
Protein subunit

Sarbeco
Non-primate (mucosal)
University of Alberta
Canada

(Unnamed)
Peptide subunit

All
Non-primate (mucosal)

Non-primate (mucosal)
University of Amsterdam
Netherlands

(Unnamed)
Virus-like particle

Sarbeco
Non-primate
University of California Irvine/Techimmune
USA

(Unnamed)
Viral vector

Beta
Non-primate (previously in preprint)

Non-primate (mucosal) (previously in preprint)

Non-primate (previously in preprint)

Non-primate (previously in preprint)

(There was also a paper about this vaccine’s development in 2021.)
US government grant terminated in March 2025.
University of California Irvine/Techimmune
USA

(Unnamed)
mRNA

All

Non-primate (mucosal)

Non-primate

Non-primate

Non-primate
University of Houston/Auravax
USA

NanoSTING-NS
Protein subunit
(intranasal)

Sarbeco
Non-primate

Non-primate

Non-primate

Primate, non-primate
University of North Carolina at Chapel Hill
USA

(Unnamed)
Viral vector

Sarbeco
Non-primate
(Previously in preprint)
University of North Carolina at Chapel Hill
USA

(Unnamed)
mRNA

Sarbeco
Non-primate
University of Sydney
Australia

CoVEXS5
Protein subunit

Sarbeco
Non-primate (Previously in preprint)
University of Toronto
Canada

(Unnamed)
Protein subunit

Sarbeco
Non-primate
University of Washington
USA

(Unnamed)
Protein subunit

Sarbeco
Non-primate
(Previously in preprint)

Non-primate

Non-primate (MERS vaccine developed on the same platform as GBP511.)
(See “GBP511” above in this table.)
University of Wisconsin-Madison (PanCorVac)
USA

(Unnamed)
Protein subunit

All
Non-primate

Non-primate

Non-primate

Non-primate (previously in preprint)


US government grant terminated in March 2025.
VBI Vaccines
Canada

VBI-2901
eVLP


All
Non-primate

Non-primate (Press release)
This company declared bankruptcy in late 2024.

Phase 1 trial
(103 participants in Canada)
Began October 2022.
Fully recruited.
(Further background info.)
Results (press release only).
(101 participants)
Previously vaccinated people boosted with 2 low or high doses, or 1 high-dose. Limited data reported. Some signs of immune response to a range of coronaviruses, mostly lasting at least 5 months. No major safety concerns.
Vaccine and Infectious Disease Organization (VIDO), University of Saskatchewan
Canada

Unnamed
Protein subunit

Sarbeco
Non-primate
Walter Reed Army Institute of Research (WRAIR)
USA

SpFN/ALFQ
Protein subunit

Beta
Non-primate

Non-primate

Non-primate (incl RFN)

Non-primate

Primate

Primate

Primate (with J&J vax)
Phase 1 trial
(US)
Began April 2021, with 29 participants, including some on placebo.
Results.
Vaxed participants showed immune responses to several Covid variants and several sarbecoviruses, but no signs of response to MERS.
Walter Reed Army Institute of Research (WRAIR)
USA

RFN
Protein subunit

Beta
Non-primate (incl SpFN)

Primate
Washington University in St Louis
USA

(Unnamed)
Viral vector

Sarbeco
Non-primate (mucosal)
Yale University
USA

(Unnamed)
mRNA

All
Non-primate

Non-primate
Yale University/Xanadu Bio
USA

(Unnamed)
Protein subunit

Sarbeco
Non-primate

Non-primate

Back to contents

Addendum 4: 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, and have tested for signs of response to non-SARS-CoV-2 coronavirus(es) (or clearly plan to).

Back to contents

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).

~~~~

Correction on October 31, 2025: I had reported that COVCHIM-02 had completed recruitment in August based on the information at the trial registry record. However, it is still recruiting.

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.)

Discussion
  1. I just wish Kostaive was actually *available* anywhere in Europe – “approved” doesn’t do much if you still can’t get ahold of it.

    1. Yes, I wish the manufacturers would say more about their plans for supply: Took months to be available in Japan, too.

  2. Thanks for these updates, I read them every month. Can’t wait for a vaccine that gives some sense of actual safety from COVID and particularly long COVID.

  3. This is all great news, but I feel like we never get closer to answering the big question: When will we have a vaccine in the U.S. that largely prevents transmission? I will go to Canada if I have to, but they don’t seem to be moving much faster with approvals.

    Anyone have a hot take on timing here? (we have an immunocompromised family member and heading into year 7 of limitations…ugh, it’s hard to stomach)

  4. I always look forward to and appreciate these updates, Hilda. Please keep them coming (as your time/schedule permits, of course)!

  5. Thank you for this! I will keep a lookout for an October (November?) update and am so grateful that you take the time to make these truly invaluable posts!

    1. Thanks! (The October post is late because a major coronavirus tracker was released on the 30th, and it has taken me ages to comb through it thoroughly – posting shortly.)

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