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01 News | The internal information of Kexingjiao vaccine data reveals that the government has not "received goods" and the political circles criticize bureaucrats

2021-02-04T23:10:11.589Z


The new crown pneumonia epidemic has lasted for more than one year, and countries have begun to vaccinate. Hong Kong has approved German BioNTech for emergency use and is expected to arrive in Hong Kong at the end of February. The emergency procurement of the British AstraZeneca vaccine will be available later.


Political situation

Author: Zheng Baosheng

2021-02-05 07:00

Last update date: 2021-02-05 07:00

The new crown pneumonia epidemic has lasted for more than a year, and countries have begun to vaccinate. Hong Kong has approved Germany's BioNTech for emergency use and is expected to arrive in Hong Kong at the end of February. The emergency procurement of the British AstraZeneca vaccine will be available to Hong Kong later.

The Vaccine Related Committee of the Department of Health recommended at the end of January to focus on the vaccines of BioNTech and AstraZeneca first. As for the vaccines of Kexing in the Mainland, the application progress has not been much progress, and the outside world is also quite vague about the progress.

"Hong Kong 01" received news that Kexing had already submitted information and application documents to relevant departments of the Department of Health at the end of January, and is awaiting review.

A government spokesperson responded to inquiries and stated that the Department of Health is working to sort out the relevant information and at the same time request that Kexing provide the Phase III clinical study data submitted to the World Health Organization as soon as possible.

In other words, the government insists that Kexing submit the third phase clinical research data before it "green light."

Sources criticized the "bureaucrats" of the authorities for failing to achieve "urgent public urgency."

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Meeting with the Department of Health in mid-January, the other party stated that the data should be published in academic journals

Sources said that the Center for Health Protection has been following up the progress of Kexing Vaccines. Kexing also had a meeting with the Pharmacy Department of the Department of Health on January 14 to update the development of Kexing Vaccine Phase III and learn about the application details.

At the meeting, representatives of the Pharmacy Department pointed out that Kexing needs to submit complete data before accepting applications. These data need to be published in authoritative medical journals or be peer reviewed.

The first and second phases of Kexing’s data have been published in authoritative medical journals, but the data and reports of the third phase of clinical tests conducted in Brazil, Turkey and Indonesia have not been published in relevant journals, nor have they been submitted to peers. Review.

Therefore, the representative of the Pharmacy Department of the Department of Health said that Kexing's information was not complete and would not be accepted.

The government did not hold an expert meeting to formally submit information on January 25

According to the source, Kexing submitted the application documents to the Health Protection Center for reference on January 24, and submitted the application letter and related materials to the office of the Food and Health Bureau on January 25 (last Monday) , Is waiting to review whether to accept the application.

Sources believe that the government’s handling methods are too bureaucratic and they think it can be handled flexibly, otherwise it may delay the progress of the vaccination. "Vaccine data must be published in authoritative medical journals, as they have to be reviewed by multiple people, which can take as short as two or three months. It lasts a year and a half. Can the Hong Kong epidemic wait so long?"

The government did not convene an expert meeting to review the data to

urge Kexing to submit the third phase clinical data as soon as possible

If the government wants to approve a certain vaccine, the current mechanism needs to be approved by the expert committee before it can be officially approved.

It is understood that the government has not yet convened an expert meeting to review relevant information about Kexing vaccine.

A government spokesperson replied to the "Hong Kong 01" inquiry on Wednesday (3rd) that the Department of Health has been actively following up with Kexing in order to obtain the third phase clinical study data of its new crown vaccine as soon as possible to ensure that the safety, efficacy and quality are sufficient for recognition For emergency use.

According to Kexing’s latest reply, Kexing is preparing relevant information and will submit it to the Department of Health as soon as possible.

According to the Prevention and Control of Diseases (Use of Vaccines) Regulations, the Chief Executive appointed a committee of vaccine advisory experts to review information on vaccines and make clear recommendations to the government.

The Food and Health Bureau will consider the advice of the advisory expert committee before approving the vaccine for emergency use.

With regard to some of the information submitted by Kexing earlier, the Department of Health has begun to sort out the approval process as soon as possible. At the same time, Kexing is also required to provide the Phase III clinical study data submitted to the World Health Organization as soon as possible.

Authoritative journals have experts evaluating the international medical community as gatekeepers

At present, the new crown vaccines in Europe and the United States must publish the third phase of clinical test reports in authoritative medical journals before they can be formally approved as approved vaccines for use by people everywhere.

Since authoritative medical journals evaluate the content of each report by a panel of experts, international medical organizations and governments will regard journals as "gatekeepers". In the approval process of various drugs, treatments or vaccines, they will consider whether It has been published in medical journals, so there are authoritative academic journals to publish reports, which is regarded as beneficial for the export of vaccines to other countries.

▼The Hong Kong Society of Hospital Pharmacists explained Fosun vaccine▼

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Russian Vaccine Testing Journal published a report on February 2

Since medical journal experts need to evaluate each report in detail, it may take a long time for the report to be published after submission.

Take the Russian "Satellite V" vaccine as an example. The third phase of testing of 40,000 people was conducted in early December last year. The preliminary data was released on December 15, but it will take about a month and a half, that is, February 2 to officially publish the "Needle". Publish the report.

Kexing said that the vaccine efficacy meets the WHO and national standards and the conditional listing application was accepted by the China Food and Drug Administration

New crown vaccine | 10 gymnasiums changed to inoculation centers, government subsidy agencies at least one-third of the cost

New crown pneumonia|The effective rate of Russian satellite V vaccine is nearly 92%, which can supply 700 million people this year

Sinopharm vaccine bypasses the expert committee?

Lin Zheng: You need to look at the data center to understand that there is a framework for vaccine approval

New Crown Vaccine | Experts say that the key to the third phase of the data is the number of people and conclusive indicators

New Crown Vaccine|Nie Dequan: The vaccination plan must invite multiple medical institutions to assist in half a year

New Crown Vaccine | Xu Shuchang said that the introduction of the third phase of the report belongs to the WHO standard, Singapore is also waiting for Kexing

New Crown Vaccine | Sinopharm Vaccine has not issued the third report Liang Zhuowei: solid data is needed for approval

Dismantling the Bureau│The ins and outs of Lin Zheng's request for vaccines from the Mainland to Hong Kong

01News

New crown pneumonia new crown vaccine

Source: hk1

All news articles on 2021-02-04

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