Vaccines | Two more new crown vaccines are on the market to check the current status of domestic COVID-19 vaccine research and development

On February 25, the State Food and Drug Administration conditionally approved the new coronavirus inactivated vaccine (Vero cell) of Sinopharm Wuhan Institute of Biological Products and the recombinant new coronavirus vaccine (type 5 adenovirus vector) of Cansino Bio Application for registration of a new crown vaccine.

Up to now, the marketing registration applications for 4 domestically produced new crown vaccines have been conditionally approved by the State Food and Drug Administration.

1.

The new inactivated vaccine from Sinopharm China Biotech was approved by the NMPA for conditional marketing at the end of December 2020, becoming China's first inactivated vaccine for new crowns approved for marketing.

On October 16, 2020, the international medical academic journal "The Lancet" published the results of the vaccine phase I/II clinical trial.

The results of the study on neutralizing antibodies induced by candidate vaccines and positive conversion rate showed that in the phase I clinical, in the healthy adult group, the seroconversion rate of the population vaccinated with low and medium doses reached 100% on the 14th day, and the seroconversion rate of the population vaccinated with high doses The seroconversion rate reached 96% on the 14th day.

This result indicates that the vaccine can effectively induce the production of neutralizing antibodies in this age group.

The results of the interim analysis of the phase III clinical trial showed that: after two injections of the immunization program, the vaccinated persons in the vaccine group produced high-titer antibodies, and the neutralizing antibody positive conversion rate was 99.

2.

On February 5, 2021, the State Drug Administration has conditionally approved Beijing Kexing Zhongwei Biotechnology Co.

It is reported that the commercial name of this vaccine is Kellyford, which is suitable for vaccination of people 18 years of age and above.

Koschenkellife® is made by inoculating African green monkey kidney cells (Vero cells for short) with the new coronavirus (CZ02 strain), which is made by culturing, harvesting the virus liquid, inactivating the virus, concentrating, purifying and adsorbing aluminum hydroxide.

On April 16, 2020, the vaccine entered a phase 1/2 clinical study and showed good safety.

Phase III clinical studies conducted in Brazil and Turkey respectively evaluated the protective efficacy of Kellyf® in high-risk groups (medical staff receiving COVID-19 patients) and the general population.

As of December 16, 2020, a total of 12,396 subjects have been enrolled in a Brazilian study of medical staff aged 18 and above, and 253 valid cases during the monitoring period have been obtained.

The target population of Turkey's Phase III clinical trial is 18-59 years old at high-risk medical staff (K-1) and the general population at normal risk (K-2).

3.
CanSino Bio: Recombinant new coronavirus vaccine (type 5 adenovirus vector)

On February 25, 2021, the recombinant new coronavirus vaccine (adenovirus type 5 vector) (Ad5-nCoV) KeweishaTM developed by Cansino Biotech Co.
, Ltd.
and the Institute of Bioengineering of the Academy of Military Medicine of the Academy of Military Sciences was listed conditionally The application has been approved.
This is China's first single-dose new crown vaccine approved for conditional marketing.

According to the announcement, CanSinoBio has carried out global multi-center phase III clinical studies in five countries including Pakistan, Mexico, Russia, Chile and Argentina, and has completed the inoculation and interim data analysis of more than 40,000 subjects.

The results of the analysis of the data in the phase III clinical trial of Cansino Bio-Kwisha showed that 28 days after a single injection of vaccination, the overall protective effect of the vaccine on all symptoms was 65.
28%; 14 days after a single injection of vaccination, the overall protection of the vaccine against all symptoms The effectiveness is 68.
83%.
The protective efficacy of the vaccine against severe illnesses was 90.
07% after 28 days of single-dose vaccination; 95.
47% after 14 days of single-dose vaccination.
This means that a single injection of Kevisa TM can produce a protective effect in only 14 days, realizing faster and more comprehensive protection of the population.

To fight the new coronavirus, speed is the key.
A single-dose vaccine "sees an effect" can make the human body immune in the fastest time, thereby quickly blocking the invasion of the virus.
In addition, under the same production capacity, a single dose of the vaccine also means that the number of people that can be protected is twice that of the two doses.
In addition, because this vaccine uses the adenovirus vector technology route, it can be stored stably between 2°C and 8°C, which is easier for normal transportation and transportation, just like the recombinant Ebola virus vaccine (adenovirus vector) developed by the same technical route.
Stored, vaccines are more accessible.

4.
Wuhan Biology: Inactivated vaccine against new coronavirus

Following the approval of the conditional listing of the new crown inactivated vaccine of the Beijing Institute of Biological Products of Sinopharm Group in 2020, on February 25, 2021, the National Medical Products Administration approved the conditional listing of the new crown inactivated vaccine of the Wuhan Institute of Biological Products .
This is the second new crown vaccine approved by China Biotech for conditional marketing.

From July 16, 2020, Wuhan Institute of Biological Products will carry out phase III clinical trials of the new crown inactivated vaccine in the United Arab Emirates and other countries.
The trial adopts an international multi-center, randomized, double-blind, placebo parallel-controlled design.
The results of the interim analysis of the phase III clinical trial showed that the safety of the new coronavirus inactivated vaccine from Wuhan Institute of Biological Products of China Biology was good.
After the two-shot immunization program, the vaccinated persons produced high-titer antibodies and neutralized antibodies.
With a rate of 99.
06%, the new crown vaccine has a protection rate of 100% against diagnosed moderate and severe diseases, and the total protection effect is 72.
51%.
The vaccine has a good cross-neutralizing ability against the new coronavirus strain, and the anti-new coronavirus antibody produced by the vaccine has a wide range of cross-neutralization reactions against 10 strains of the new coronavirus that are circulating at home and abroad or representative of the new coronavirus.

5.
Fosun Pharma and BioNTech: mRNA COVID-19 vaccine

On January 25, 2021, the mRNA new crown vaccine BNT162b2 (BNT162b2) from Fosun Pharma and BioNTech obtained special import approval in Macau, China.
This is a new crown vaccine based on BioNTech's mRNA technology, which has previously been approved for emergency use in Hong Kong, China.
BioNTech and Fosun Pharma announced in March 2020 that they have reached a strategic cooperation agreement.
The two parties will jointly develop and commercialize BioNTech’s proprietary mRNA technology platform based on BioNTech’s proprietary mRNA technology platform in the Greater China region and target the novel coronavirus.
Virus vaccine products.

mRNA is a naturally occurring molecule that can produce target proteins or immunogens and activate the immune response in the body to fight various pathogens.
According to reports, compared with traditional vaccines, mRNA vaccines have many advantages, including: no virus components, no risk of infection; short research and development cycle, which can quickly develop new candidate vaccines to respond to virus mutations; dual mechanisms of humoral immunity and T cell immunity , Strong immunogenicity, no adjuvant is needed; easy to mass produce.

According to an earlier press release issued by Fosun Pharma, the results of the global phase 3 clinical trial showed that BioNTech's mRNA COVID-19 vaccine has reached all major efficacy endpoints, and its effectiveness in preventing COVID-19 infection is 95%, targeting people over 65 years of age.
The effectiveness of adults exceeds 94%.

6.
Clover biology: "S-trimer" new crown vaccine candidate

"S-Trimer" is a new type of coronavirus surface antigen S protein trimer subunit candidate vaccine, and uses the unique Trimer-Tag© (protein trimerization) patented technology of Clover Biology.
Similar to other enveloped RNA viruses such as HIV, Respiratory Syncytial Virus and Influenza Virus, the new coronavirus is also an RNA virus.
Its surface antigen S protein also has a trimer structure, and the virus interacts with it through its trimer antigen (S protein).
The host cell surface binds to the ACE2 receptor and enters human cells, making it the main target antigen for vaccine development.
"S-trimer" is similar to the natural trimeric virus surface protein and can be rapidly expressed by mammalian cell culture.

Pre-clinical research data and preliminary phase 1 clinical data show that: the "S-trimer" new crown vaccine candidate is well tolerated, and can induce strong neutralizing antibodies and Th1-biased cellular immune response, which is worth continuing Evaluation.

7.
Kangtai Bio/AstraZeneca: Adenovirus vector new crown vaccine AZD1222

On August 6, 2020, AstraZeneca announced that it had signed an exclusive authorization cooperation framework agreement with Kangtai Biologics in the Chinese mainland market to actively promote the research and development of the adenovirus vector new crown vaccine AZD1222 in the Chinese mainland market through technology transfer.
Production, supply and commercialization.
In the future, the two parties will continue to explore the possibility of cooperation with the vaccine in other regions and markets.

On November 23, 2020, AstraZeneca announced that the Phase III clinical interim analysis of AZD1222 has reached the primary efficacy endpoint.
Based on the data of 332 symptomatic COVID-19 patients accumulated in 17,177 subjects, one dose of the vaccine can produce 76% of the protective effect, and the interval between two inoculations is more than 12 weeks, and the protective effect of the vaccine reaches 82%.
.
In terms of protection against severe COVID-19, the effectiveness of two doses of the vaccine is 100%.
Previously, the British regulatory agency had granted emergency use authorization for the vaccine and recommended that the interval between two vaccinations be 4-12 weeks.

At present, clinical trials of the vaccine are being conducted in many countries around the world and planned to be carried out in more regions to verify the effectiveness of the vaccine in protecting people from new coronavirus infections, and to test the safety and immune response of different age groups and doses.
So far, AstraZeneca has reached cooperation agreements with many countries and organizations around the world.

The war against COVID-19, after a long and dark year, human society has paid the price of more than 60 million infections and 1.
48 million deaths, finally ushered in the dawn of dawn, and the emergence of vaccines makes this The dawn is getting brighter and brighter.

Reference source:

1.
Safety and Immunogenicity of an Inactivated SARS-CoV-2 Vaccine, BBIBP-CorV: a Randomised, Double-blind, Placebo-controlled, Phase 1/2 Trial;

2.
Tests confirm that Butantan vaccine is the safest in the final stage in Brazil.
Retrieved October 20, 2020, from https:// informacoes-sobre-o-combate-ao-coronavirus-3/;

3.
China's Sinovac vaccine is safe, Brazil institute says.
Retrieved October 20, 2020, from https://in.
reuters.
com/article/health-coronavirus-sinovac-brazil/update-1-brazils-butantan-says-tests -show-vaccine-by-chinas-sinovac-is-safe-idINL1N2HA14F;

4.
Retrieved Feb.
10, 2020, from http:// style="vertical-align: inherit;">5.
AstraZeneca COVID-19 vaccine authorised for emergency use by the World Health Organization.