Research, editing : Gan Yung Chyan, KUCINTA SETIA
Translation of external news on disease control and Taiwan
News (1)
The first batch of 265,000 doses of MVC-COV1901 is here! More than 900,000 people are willing to vaccinate MVC
Reporter : Wu Liangyi / Image: The reporter participated in the second phase of clinical trial vaccination of MVC Vaccines' MVC-COV1901 on 16 March 2021. (Data photo, photo by reporter Wu Liangyi)
Taiwan's Food and Drug Administration announced to Taiwan media on 2 August 2021 that 4 batches of a total of 265,528 doses of Medigen Vaccine Biologics (MVC Vaccines, Medigen) MVC COVID-19 vaccine (MVC-COV1901) have been tested and sealed, and the sealing stickers can be delivered to various places for vaccination. According to the statistics of the vaccine willingness registration platform, more than 900,000 people are willing to receive MVC-COV1901.MVC Vaccines produced the first 4 batches of MVC-COV1901 totaling 265,528 doses. The Food and Drug Administration said today that it has completed the review and inspection and issued a sealing certificate, and is undergoing inspection and sealing operations in the warehouse. It is expected to be delivered after the labeling is completed today.
The covid vaccine produced by MVC Vaccines has applied to the Food and Drug Administration for batch-by-batch inspection and sealing. The Food and Drug Administration sent personnel to the low-temperature storage site to check the vaccine batch number, count the number, and check the cold chain. 600 samples of each batch of vaccine were taken for testing and foreign body inspection.
After sealing the vaccine on site, bring the sample back to the National Laboratory of Food and Drug Administration for appearance, identification, pH value, aluminum content, CpG content, total protein content, antigen content, bacterial endotoxin, sterility, potency, and abnormal toxicity tests.
Xu Jiaquan, head of the research and inspection team of the Food and Drug Administration, said that the inspection and sealing of high-end vaccines will not simplify any inspections like AZ or Moderna and other foreign vaccines. The complete inspection and sealing process will be completed, which is expected to be completed in 30 days.
He also pointed out that the MVC-COV1901 is a protein subunit vaccine, which is different from the adenovirus vector (AZ) and mRNA (Modena) vaccine test items. In particular, the potency test item must be carried out by animal testing. This item will have to wait 21 days before it can be used. To confirm whether the vaccine produces sufficient protection, it will take at least five weeks to close the test in the future.
Xu Jiaquan said that MVC Vaccines had already sent vaccines for testing and sealing. The Food and Drug Administration issued the sealing certificate in the evening of 30 July but the inspection and sealing operations are still in storage this morning. It is expected that the sealed vaccine can be delivered within today for follow-up vaccination operations by the Department of Disease Control.
Ref: https://news.ltn.com.tw/news/life/breakingnews/3624313
News (2)
Ready for Taiwan vaccination! MVC 265,000 doses of vaccines obtained sealing certificates
Reporter : Weichen Ye
On 30 July 2021, Taiwan's Food and Drug Administration announced that it has issued a seal certificate for 265,000 doses of high-end vaccines. According to the Food and Drug Administration, it has completed the production of the first 4 batches of high-end MVC COVID-19 Vaccine (MVC-COV1901) with a total of 265,000 doses. The batch numbers and number of doses per batch for for review, inspection and issue a sealing certificate are as follows:-
Batch number SP2106, 86,979 doses; batch number SP2107, 5,417 doses; batch number SP2111, 86,391 doses; batch number SP2112, 86,741 doses.
The Food and Drug Administration sent personnel to the low-temperature storage site to check the vaccine batch number, count the number, and check the cold chain. 600 samples of each batch of vaccine were taken for foreign body inspection. After the vaccine was sealed on site, the samples were brought back to the national laboratory for appearance, identification, pH value, aluminum content, CpG content, total protein content, antigen content, bacterial endotoxin, sterility, potency, and abnormal toxicity.
The first four batches of vaccines totaling 265,528 doses were reviewed by the Food and Drug Administration. The sealing certificate was issued in the evening of 30 July, and the sealing operation was carried out in the warehouse. The sealed vaccine can be handed over to the Department of Disease Control for follow-up vaccination operations.
Ref: news.tvbs.com.tw/life/1557118
News (3)
MVC EUA meeting minutes announced. Experts have opinions on
the lack of ``T cell'' response
Reporter : Wu Liangyi, LTN
Image : The final inspection of high-end vaccine vaccine packaging
before shipment. (Data photo)
The Food and Drug Administration announced today that a
total of 265,000 doses of MVC-COV1901 from MVC Vaccines have been tested and
sealed, which can be distributed to various places for vaccination, and an
emergency use authorization has also been announced (EUA) meeting minutes. Although
the experts almost agree, they generally have opinions on the "T
cell" immune response of high-end vaccines, and more relevant research and
information are required to be supplemented.
After the emergency use authorization was reviewed and
approved, all walks of life expressed their opinions on the meeting process and
requested the publication of meeting materials. Minister of Health and Welfare
Chen Shizhong also promised to publish it two weeks after the approval, which
has been posted on the official website of the Food and Drug Administration
today. A total of 21 experts attended the review meeting. The chairperson did
not participate in the voting. 3 people passed, 15 people passed conditionally,
1 additional person was discussed for the supplement, and 1 person did not pass.
Although most experts agree that the emergency use
authorization is approved, they have expressed their opinions on the lack of
relevant figures for the "T cell immune response". T cells play an
important role in the immune response. Some experts pointed out that in
addition to antibodies, there are other mechanisms such as T cells that can
produce protection. The current internationally approved vaccines also provide
assessments of T cell responses. MVC related data should be requested. At
present, there is not enough evidence.
In addition, experts also mentioned that the most frequently
criticized shortcomings of MVC vaccines are that the antibody titer is not
equivalent to the actual protection; and estimated by neutralizing antibodies,
the protection effect is between Moderna and AZ vaccines but the actual
protective power is unknown. The effect on "Delta" and
"Beta" is poor. Short-term use
is acceptable, and long-term effects require more information.
In addition, MVC Vaccines also need to follow the emergency
use authorization of vaccines from foreign vaccine factories, which will be
effective during the establishment of the Central Epidemic Epidemic Command
Centre. When the command centre is closed, it means that the epidemic has
dissipated and the emergency use authorization is also invalid. You must apply
accordingly for a drug license according to regulations.
According to the resolution of the meeting, MVC Vaccines
should continue to implement the monitoring plan during the project approval
and manufacturing period, provide monthly safety monitoring reports, and send
domestic and foreign implementation vaccine protection benefit reports within
one year after approval.
In order to ensure the consistency of manufacturing quality,
MVC is also required to provide the test results of the percentage of sialic
acid glycosylation of the 50L process APIs on a batch-by-batch basis until the
50L API manufacturing process is validated, and at the same time continue to
update the stability of the API and finished product production batches. Sex
test results.
Experts also suggest that MVC should continue to invest in
vaccine-related research, such as antibody persistence and vaccine protection,
T cell immune response, and the third dose of additional enhancement effects.
In the future, they should aim to obtain licenses or international
certifications.
Ref: https://news.ltn.com.tw/news/life/breakingnews/3624370
News (4)
MVC mass production and inspection without EUA provoke disputes
Source : LTN
Image : The Food and Drug Administration today announced the completion of the testing and sealing of a total of 265,000 doses of MVC COVID-19 Vaccine (MVC-COV1901). (Provided by the Food and Drug Administration)
The Food and Drug Administration announced on 2 August 2021 that the first batch of about 265,000 doses of the MVC COVID-19 vaccine (MVC-COV1901) has been tested and sealed, and it can be distributed to various places. Sending for inspection before passing the emergency use authorization (EUA) has also caused controversy. Chen Shizhong, commander of the Central Epidemic Command Centre, said that in response to an epidemic emergency, the speed should be fast. If manufacturing and sending for inspection have to wait for EUA to pass, it may wait another six months.
Regarding the MVC-COV1901 that passed the inspection and sealing today, Chen Shizhong explained at the epidemic press conference that the administrative process of domestic vaccine research and development is simplified in emergency situations. In 2020, a special counseling team was sent to the manufacturer to counsel and try to avoid administrative paperwork, and speed up the administrative process outside the experiment.
Chen Shizhong said that vaccine research and development and testing and administrative procedures are carried out in parallel and overlap with each other. This is to speed up the speed. "Generally, this will not be the case because the risk is high and the research and development may fail."
Chen Shizhong said that many countries have different ways of assisting domestic vaccines. Take the United States as an example. The government has given a large amount of money to manufacturers for research and development. After successfully signing a contract, it will not get it back, and failure is considered an investment. Many countries use these methods to share the financial risks of pharmaceutical companies.
Chen Shizhong said that during the review of the EUA, Taiwan made the product first because it is to respond to emergencies, so it is required to be fast. Of course, EUA also has the risk of failure, and manufacturers are not willing to wait so they will get the vaccine ready first, and this also takes time. He said, "It's not like making cakes. Making cakes may fail, not to mention that vaccines are high-tech products."
Chen Shizhong said that the government uses pre-purchasing to allow manufacturers to share the risk. Regardless of material purchases, syringes, raw materials, and adjuvants, they must be prepared in advance. If they wait until the EUA is passed, they will have to wait at least half a year, but if all of these are passed. If the test seal fails, the entire batch of vaccines will not pass.
News (5)
MVC covi vaccine rare side effects of facial nerve palsy, high intraocular pressure, command centre confirmed 2 cases
Reporter : Wu Liangyi
The Department of Disease Control has put the MVC COVID-19 Vaccine introduction on the official website, listing common side effects such as muscle pain and pain at the injection site, as well as rare side effects including facial nerve palsy and high intraocular pressure.
The Central Epidemic Command Centre confirmed that adverse events will be collected after vaccination of various vaccines. It is understood that facial nerve palsy and high intraocular pressure occurred in these two cases after receiving high-end vaccines.
During the safety follow-up period, one subject in the MVC vaccine group reported acute peripheral facial nerve palsy, and the subject had this adverse reaction 13 days after the second dose.
Command center spokesperson Zhuang Renxiang said that this facial nerve palsy case later fully recovered but he had an upper respiratory tract infection before vaccination. Is facial nerve palsy and high intraocular pressure related to vaccination? He said that at present there is only a "time series" relationship, and whether it is really a causal relationship caused by the vaccine still needs to be understood.
News (6)
"Perhaps not participating in the Olympics anymore" Dai Ziying on her knee injury: Take a good rest
Edited by Zhang Yongling / Image : Dazhi Image AP, reproduced from Dai Ziying IG
Dai Ziying (Tai Tzu Ying) was defeated by mainland player Chen Yufei in the Tokyo Olympics badminton women’s singles gold medal. Although she fought for 81 minutes, she was defeated and won the silver medal. Still writing the best result of the Taiwan Olympics, after posting a post late at night, she took another photo of her foot injury in the early morning of 2 August, "Thank you, take a good rest!"
Dai Ziying has stood on the five-round hall three times after the 2012 London Olympics and the 2016 Rio Olympics. The fighting during this period also left her feet and knees broken and bruised, but Xiao Dai’s spirit of persisting to the end has moved many people. She wrote on her Facebook late at night of 1 August, "Standing on this dream stage for the third time, finally made it to the finals, but was unable to stand at the highest level. On the podium, there is always a little regret, but imperfections always exist, and only then can I have the motivation to pursue better results."
Dai Ziying mentioned that she might not have another chance to participate in the Olympics, but this goal can be regarded as achieved, but it is not so perfect. "I just want to tell myself: Dai Ziying, you are great.”
Although the results are always cruel, she has tried her best. Xiao Dai also thanked those who helped during this period her training, "Thank you for everything.”
Xiao Dai also shared that after the gold medal match, she was initially satisfied with his performance, but saw the Indian player Sindhu who was fighting the other day running to hold her face and hugged her and said, "I know that you are uncomfortable, you have performed very well, but today is not your game." The sincere encouragement also made Xiao Dai burst into tears, saying, "It's really too sad, because I really worked hard."
In the end, Xiao Da thanks everyone again for their support and encouragement, "Thank you for walking with me until now." Dai Ziying did her best during the competition.
In the early morning, she took a photo of her legs and feet in a limited-time dynamic PO on IG and said, "Thank you, my knees, take a good rest!" You can see Xiao Dai's knees are full of bruises and even broken. The skin bruises are distressing. Many netizens also commented on "Xiao Dai, you are great", "I fell in love with Sindhu directly, Xiao Dai has worked hard, thank you for your hard work," and "You are really great, it belongs to us. "Idol", "You are the number one in our hearts", "You are great, you have always been."
Refs: news.tvbs.com.tw/sports/1557081, https://news.tvbs.com.tw/sports/1557137
News (7)
Shuangbei announced that from 3 August onwards, internal dining in the night market allowed. Eating when walking prohibited
Image : Web Screenshot
Shuangbei tomorrow allows internal dining, Taipei Mayor Ke Wenzhe said that he will observe for two weeks before considering further relaxation. Shuangbei is a co-living circle with the same standards. They will also pay attention to any changes in the epidemic and call on the public not to underestimate the enemy.
The Taipei City Government held a press conference on the covid epidemic in the afternoon. Ke Wenzhe said that the restaurants and night markets in Shuangbei will be open for internal dining tomorrow, and will be observed for two weeks. The Northern Government added that eating while walking in the night market is prohibited. Ke Wenzhe said that Taipei and New Taipei City are the Shuangbei capital living area. It is impossible for the standards to be different. The release time and standards used in this relaxation are all coordinated to the same.
Although the escalation of the epidemic alert has not been discussed, it will be careful of any disturbances. If the epidemic situation rises too severely, call a card immediately. This is the new normal.
Ke Wenzhe said that he does not hope that the restaurant night market will be full from tomorrow. This wave of epidemic outbreak in Taiwan has taken two and a half months to suppress. It has been very powerful. He hopes everyone will cherish it. Take the new case in Taipei as an example. There is still an unknown source of infection.
Chen Yiting, head of the Food and Drug Administration Section of the Health Bureau, added that all bureaus and departments of the city government are assigned to dining inspections. As long as there is a catering industry in the area, there is an inspection responsibility, and there is no need to worry about manpower. Ke Wenzhe said that this relaxation is to be cautious and fearful, walking on thin ice, hoping to achieve a balance between epidemic prevention and economics, and many living habits need to be adjusted slowly. (Central News Agency)
News (8) to (10) / Source : Mingpao
Translation of external news on disease control and Hong Kong
News (8)
Hong Kong: Social distancing measures are extended by two weeks until 18 August. Class B restaurant staff testing requirements will be tightened within August
Image : Photo of Director of Food and Hygiene Chen Zhaoshi
The Secretary of Food and Health, Chen Zhaoshi, announced today (2 August) that the social distancing measures that expired on 4 August 2021 will be extended by two weeks to 18 August and the inspection requirements for category B restaurant employees will be tightened from every 14 days in August. Changed to once every 7 days, employees who have completed the vaccination will be deemed to have met the testing requirements.
News (9)
Hong Kong reports 4500 reports of adverse reactions to vaccination
Chen Zhaoshi said that as of 25 July, the authorities had received 4,500 reports of abnormal vaccine incidents. So far, 6 applications from the Vaccine Protection Fund have been approved, involving cases of severe allergies, hospitalization and facial paralysis, involving a total of HK$750,000 yuan. All are not serious cases.
News (10)
Visitors from high-risk areas to Hong Kong must be Hong Kong residents who have completed vaccination. Those who have not received the vaccine will extend the quarantine period by 7 days
Image : Profile picture of Chief Executive Carrie Lam Cheng Yuet-ngor
Chief Executive Carrie Lam Cheng Yuet-ngor held a press conference this afternoon of 2 August to announce the latest novel coronavirus (SARS-CoV-2, covi) epidemic prevention measures.
Foreign defense input: Reclassify foreign areas into high, medium, and low-risk areas
. All visitors to Hong Kong must present a negative certificate of the covi nucleic acid test 72 hours before departure when boarding the plane
. High-risk areas: Only Hong Kong residents who have completed the COVID-19 vaccination are allowed to board the plane and come to Hong Kong
. Medium-risk areas: Only Hong Kong residents and non-Hong Kong residents who have completed vaccination are allowed to board the plane to Hong Kong
. All overseas visitors must be quarantined at designated quarantine hotels, complete vaccination, quarantine from high-risk areas for 21 days, medium-risk areas for 14 days, and low-risk areas for 7 days; those arriving from medium-risk areas if they have a positive antibody test in Hong Kong , they can change to quarantine at the designated hotel for 7 days, plus 7 days for self-monitoring; for those who have not been vaccinated, the quarantine period will be extended by 7 days for those arriving in Hong Kong by region
. Strengthen inspections on whether arrivals in Hong Kong are subject to compulsory testing in accordance with regulations and on time, and will step up prosecution of violators
Some foreign domestic helpers are listed as "Group A1" designated areas because of their place of origin. Even if they have completed the covid vaccination in Hong Kong, they still cannot return to Hong Kong after returning to their hometown. The Secretary of Labor and Welfare Luo Zhiguang said that these foreign domestic helpers can do so under the new arrangement.
Returning to Hong Kong: For foreign domestic helpers who failed to return to their hometown for holiday after the completion of the previous contract, they can return to Hong Kong after returning home as long as they have completed the vaccination in Hong Kong but they must still be quarantined at the designated hotel for 21 days.
In addition, the Hong Kong government will discuss with the governments of the foreign employers’ sources, including the Philippines and Indonesia, to review how to verify the authenticity of the local vaccination certificate through the local government, so as to allow foreign domestic helpers who have completed the vaccination to come to Hong Kong to perform their duties. The Hong Kong government will arrange for quarantine at one or two designated hotels. The arrangements will be announced after the Labour Department has discussed with the health authorities and confirmed the details.
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