When will New Vaccines Specially Against COVID-19 Omicron be available?

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When will New Vaccines Specially Against COVID-19 Omicron be available?

The severity of Omicron

The Omicron variant has surpassed Delta and is currently the mainstream variant in the world .

Since its discovery in December 2021, Omicron has infected at least 2 billion people worldwide and killed more than 50,000 people . The WHO believes that Omicron will become the world’s biggest threat for a long time to come.

Scientists around the world are racing to study vaccines against Omicron, but for Omicron mutants in 9 Whether it will still be the most mainstream virus after a few months, scholars still have differences of opinion and understanding.

Pfizer-BioNtech Omicron vaccine

In late January, Pfizer and BioNTech announced the launch of two vaccines, a new version of the vaccine against the Omicron variant and a multivalent COVID-19 vaccine against both Omicron and previously circulating strains. Prior to this, the COVID-19 vaccine developed by Pfizer and BioNtech was one of the first vaccines approved for use in the world.

When will New Vaccines Specially Against COVID-19 Omicron be available? Image source: pfizer official website

Pfizer plans to test the two vaccines in unvaccinated people, hoping to determine the protection the new vaccine provides as a booster and three single doses.

More than 1,400 adults aged 18-55 are planned to participate in the clinical trial , which will test the vaccine’s safety, tolerability and efficacy, as well as how it boosts the immune system compared to the original vaccine.

In one study group, about 600 volunteers who received two doses of Pfizer’s current vaccine three to six months ago will receive one or two boosters of the omicron-based vaccine.

Another 600 Pfizer vaccines who have already received three doses of the regular vaccine will receive a fourth dose of the regular vaccine or a matching version of the omicron.

The study will also enroll some unvaccinated volunteers who will receive three doses of the omicron-based vaccine.

When will New Vaccines Specially Against COVID-19 Omicron be available? Image source: pfizer official website

But Pfizer’s Omicron vaccine may be hitting some hurdles right now . In February, Pfizer CEO Albert Burra announced that the Omicron vaccine would be available in March.

But it has not been released yet. Ugur Sahin, CEO of Germany’s BionTech, said the Pfizer Omicron vaccine may not be able to submit relevant data in the near future due to a slower-than-expected data collection process.

And Omicron’s popularity declined in March, and Pfizer is now considering whether to move forward with the vaccine.

Oxford/AstraZeneca and Moderna have also started or are about to start researching and testing the “Omicron-targeted” COVID-19 vaccine. In March, Moderna also announced that it had begun a Phase 2 trial of its Omicron-specific booster vaccine, which will include 375 unvaccinated adults in the United States.

Chinese Omicron vaccine: Which three vaccines have been approved for clinical use? what type?

Mr. Zheng Zhongwei, head of the vaccine research and development team of the China Joint Prevention and Control Mechanism of the State Council, introduced that on April 13 And on the 14th, three vaccines against the Omicron variant in China have started clinical trials in Hong Kong and are expected to be successfully launched in the near future.

They are BIBP-new coronavirus inactivated vaccine ( Omicron variant ) and WIBP -new coronavirus inactivated vaccine (Omicron variant) developed by SINOPHARM China Bio-Beijing Institute of Biological Products and Wuhan Institute of Biological Products. strain ) two vaccines . Kerrlife-Omicron strain novel coronavirus inactivated vaccine (Vero cells) developed by SINOVAC Holdings Biotechnology Co., Ltd.

On April 16, a subsidiary of China National Pharmaceutical Group and Kexing Holding Biotechnology said that their three inactivated vaccines against the new coronavirus Omicron have been approved to start clinical trials in Hong Kong.

▌ 1.1 Overview of R&D of SINOPHARM Group

Two novel coronavirus inactivated vaccines (Omicron variant) developed by SINOPHARM Group were officially approved to conduct sequential immunization clinical research on novel coronavirus vaccines in Hong Kong. (After the successful development of the vaccine, SINOPHARM Group China Biotechnology actively carried out in-depth cooperation with the University of Hong Kong, submitted an ethics application and a clinical trial application to the Hong Kong Research Center at the first time, and successfully obtained the ethics approval on April 12 and April 13 respectively. and clinical approval).

In the next step, a randomized, double-blind, cohort study will be used to conduct a sequential immunization clinical study in people aged 18 and over who have completed 2 or 3 doses of the COVID-19 vaccine to evaluate BIBP-novel coronavirus inactivated vaccine, WIBP – Safety and immunogenicity of the two vaccines against the novel coronavirus inactivated vaccine.

According to the news released by Sinopharm, this is the world’s first approved clinical trial of the Omicron inactivated vaccine.

The two vaccines were inoculated into Vero cells with the Cron strain, and were prepared by culture, inactivation, purification, and adsorption with aluminum hydroxide adjuvant. It was not specified which vaccine products the trial participants would receive before taking the experimental booster, or how many subjects would be recruited.

When will New Vaccines Specially Against COVID-19 Omicron be available? Image source: https://www.163.com/dy/article/H52VPRUD0550BD8K.html

▌ 1.2 Overview of SINOVAC R&D

On April 14, 2022, SINOVAC Holding Biotechnology Co., Ltd. (“SINOVAC SINOVAC”) obtained clinical approval in Hong Kong SAR for the inactivated vaccine against the novel coronavirus developed based on the Omicron variant.

It is reported that Kexing acted quickly when the Omicron variant appeared at the end of 2021, and obtained nasopharyngeal swab specimens from persons infected with the Omicron variant on December 5, 2021, and cooperated with the Chinese Academy of Medical Sciences for medical laboratory animals.

The team of Professor Qin Chuan of the Institute cooperated to carry out virus isolation and whole gene sequencing. On December 9, another sample of the Omicron variant isolated from the University of Hong Kong was introduced.

After obtaining the Omicron variant strain, SINOVAC actively promotes the research on the virus strain, cell matrix and process quality of the Omicron strain COVID-19 vaccine, and has established a tertiary seed bank for vaccine production in accordance with GMP requirements, and has been working on the prototype vaccine.

Based on the research and development ideas of the second-generation improved vaccine, the vaccine preparation process has been determined, and many batches of products have passed the self-inspection and the review inspection of the Central Inspection Institute.

SINOVAC stated that the results of preclinical studies showed that SINOVAC Omicron variant inactivated vaccine is safe and effective in animals .

A new Chinese study showed that while the fourth dose returned antibody levels to around the peaks after the third dose, the researchers said the new vaccine would provide a better alternative as a future booster.

After completing the safety and efficacy evaluation and clinical trial design based on animal models, SINOVAC began to submit clinical applications to many countries and regions at the end of February.

When Omicron vaccines become available?

According to preliminary calculations, if all goes well, the three Chinese vaccines should be available before September . The Omicron vaccines of Pfizer, Moderna, Johnson & Johnson and other biological companies have all entered the clinical trial stage.

During the SARS period, many pharmaceutical companies participated in the development of the SARS vaccine, but the sudden subsidence of the SARS epidemic wiped out all the previous investment. But as Zheng Zhongwei, head of the vaccine research and development team of the Joint Prevention and Control Mechanism Scientific Research Team of the State Council, said: “The basic principle we follow is ‘it is better to be prepared than to use, and never to use without preparation’.

References

1. Official website of SINOPHARM Group: http://www.SINOPHARM.com/

2. Press release: “The world’s first! SINOPHARM China Bio-Beijing and Wuhan Institute of Biological Products have obtained Hong Kong clinical approval for two Omicron inactivated vaccines”. http://www.SINOPHARM.com/s/1223-4126-40175.html

3. SINOVAC official website: http://www.SINOVAC.com.cn/

4. Press release: “SINOVAC Omicoron Strain Novel Coronavirus Inactivated Vaccine Approved for Clinical Practice in Hong Kong, China”. http://www.SINOVAC.com.cn/news/shownews.php?id=1447

5.pfizer official website: https://www.pfizer.com/

6. Press release: “Pfizer and BioNTech Initiate Study to Evaluate Omicron-Based COVID-19 Vaccine in Adults 18 to 55 Years of Age”. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-study-evaluate-omicron-based.