Sars-cov-2 vaccine manufacturers

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sars-cov-2 vaccine

Injection 0.5 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
Philippines; China
Manufacturer #36729

Established in 1992, this CTD dossier owner and manufacturer focuses on the research, development, production, and sales of human vaccines. As a leading CTD dossier owner and manufacturer in China, the company has developed a rich product portfolio and industry-leading scale. With significant international progress, this GMP manufacturer has expanded its business development to cover six regions and more than 20 countries. The company employs over 2,400 staff and has R&D centers and industrial bases in Shenzhen and Beijing. As a GMP manufacturer, it has undertaken numerous key scientific research projects at national, provincial, and municipal levels.

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About SARS-CoV-2 vaccine

SARS-CoV-2 vaccine manufacturers include Pfizer and BioNTech (Comirnaty), Moderna (Spikevax, mNEXSPIKE) and Novavax with Sanofi (Nuvaxovid), plus producers in China, India and other countries. SARS-CoV-2 vaccines protect against COVID-19. They are made using mRNA, protein subunit, inactivated virus or viral vector technologies, and are updated regularly to match circulating variants. Pharmaceutical companies can source COVID-19 vaccines through supply, regional licensing or technology transfer.

SARS-CoV-2 vaccine key facts

Property

SARS-CoV-2 vaccine

Vaccine types

mRNA; protein subunit; inactivated virus; viral vector

ATC codes

J07BN01 (RNA); J07BN02 (viral vector); J07BN03 (inactivated); J07BN04 (protein subunit)

Main mRNA vaccines

Comirnaty (Pfizer / BioNTech); Spikevax and mNEXSPIKE (Moderna)

Protein vaccine

Nuvaxovid (Novavax, commercialised with Sanofi)

Other vaccines

CoronaVac (Sinovac); BBIBP-CorV (Sinopharm); Covaxin (Bharat Biotech); Covovax (Serum Institute of India)

Dosage form

Suspension for intramuscular injection; prefilled syringes or vials

Indication

Active immunisation to prevent COVID-19

First full approvals

Comirnaty, US FDA, August 2021; Spikevax, US FDA, January 2022

Strain updates

Composition updated regularly to match circulating variants

US label scope (2025)

Approvals limited to people aged 65 and over and younger people with at least one high-risk condition

Discontinued products

Vaxzevria (AstraZeneca) withdrawn in the EU in 2024; Jcovden (Janssen) discontinued

Generic / biosimilar status

Not applicable; each vaccine licensed separately

SARS-CoV-2 vaccine manufacturers and licensing history

COVID-19 vaccines were first authorised for emergency use in December 2020. Pfizer and BioNTech's Comirnaty received full US approval in August 2021, and Moderna's Spikevax in January 2022. Both are mRNA vaccines. Novavax's Nuvaxovid, a protein vaccine, is now commercialised with Sanofi, and Moderna added a next-generation mRNA vaccine, mNEXSPIKE.

Other vaccines were widely used during the pandemic, including Sinovac's CoronaVac, Sinopharm's inactivated vaccine, Bharat Biotech's Covaxin and AstraZeneca's Vaxzevria. Demand has fallen sharply since 2022, and several products have been withdrawn.

Vaccines are now updated regularly to match new variants. In 2025, the US limited approvals to people aged 65 and over and younger people at high risk. Buyers should confirm the current strain composition, regulatory status in each market, cold-chain requirements and supply terms before choosing a supplier.

SARS-CoV-2 vaccine dosage forms and dossier types

SARS-CoV-2 vaccines are supplied as suspensions for intramuscular injection, in single-dose prefilled syringes or vials.

Form

Technology

Typical dossier

Notes

mRNA vaccine

Lipid nanoparticle mRNA

US BLA; EU MAA

Frozen or refrigerated storage, by product

Protein subunit vaccine

Recombinant spike protein with adjuvant

US BLA; EU MAA

Refrigerated storage

Inactivated vaccine

Whole inactivated virus

National licence; WHO EUL (historical)

Mainly China and India

Target market

Dossier format

Key requirement

United States

BLA

Annual strain update; restricted age and risk groups

European Union

MAA (variations for new strains)

EMA strain recommendations

Other markets

National licence

Check current recommendations and demand

SARS-CoV-2 vaccine regulatory and patent status

Each COVID-19 vaccine is licensed separately, as there are no generic vaccines. Regulators review updated formulas regularly to match new variants. In the US, 2025 approvals limited use to people aged 65 and over and younger people with high-risk conditions. mRNA and lipid nanoparticle technologies are covered by many patents, and several patent disputes between developers are ongoing.

SARS-CoV-2 vaccine mechanism of action and therapeutic use

SARS-CoV-2 vaccines teach the immune system to recognise the virus's spike protein. mRNA vaccines deliver instructions for cells to make the spike protein, protein vaccines contain the spike protein directly, and inactivated vaccines contain killed virus. The immune response reduces the risk of severe COVID-19, hospital admission and death, especially in older and high-risk people.

SARS-CoV-2 vaccine licensing and sourcing

SARS-CoV-2 vaccine suppliers and licensing partners typically offer finished vaccine supply, regional licensing or technology transfer, especially for mRNA platforms. Buyers usually compare regulatory approvals, strain updates, cold-chain needs and supply terms. Current offers and supplier contacts are listed among the SARS-CoV-2 vaccine manufacturers on Pipelinepharma.

Frequently asked questions about SARS-CoV-2 vaccine

Who are the main SARS-CoV-2 vaccine manufacturers? Pfizer and BioNTech (Comirnaty), Moderna (Spikevax, mNEXSPIKE) and Novavax with Sanofi (Nuvaxovid) are the main suppliers in the US and EU. Sinovac, Sinopharm and Bharat Biotech also produced widely used vaccines.

Are COVID-19 vaccines updated? Yes. COVID-19 vaccines are updated regularly to match circulating variants, based on regulators' strain recommendations.

Who can receive COVID-19 vaccines in the US? Since 2025, US approvals cover people aged 65 and over and younger people with at least one high-risk condition.

What types of COVID-19 vaccine are there? COVID-19 vaccines include mRNA, protein subunit, inactivated virus and viral vector vaccines.

Is there a generic COVID-19 vaccine? No. Each COVID-19 vaccine is licensed separately, but some technology transfer programmes support regional production.

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