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Press Conf - Batch 210102 Suspension @ 2:30PM

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  1. #1

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    Press Conf - Batch 210102 Suspension @ 2:30PM


    Split from the original thread as it seems to be overrun with speculation.

    Original Thread: https://geoexpat.com/forum/newpostinthread360156.html


    Secretary for the Civil Service, Mr Patrick Nip
    Secretary for Food and Health, Professor Sophia Chan
    Director of Health, Dr Constance Chan
    Live Stream @ 2:30PM (24th March)

    https://youtu.be/wKTt4huNoNA
    Last edited by shri; 24-03-2021 at 02:26 PM.

  2. #2

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    Updates from press conference:

    Announcements:

    • Received written information from BioNTech and Fosun on packaging issues. Investigating this issue. Vaccination program is suspended as a preventive measure. Various community vaccination centers have suspended the program pending further notice.

    • DH has met with Fosun. Govt has SMSed all the bookings today. New arrangements will be communicated later.

    • Fosun is the agent of the foreign manufacturer - responsible for communicating.

    • Two batches have been delivered (585K - 210102 - 758K - 210104). 210102 has been in use so far. 150K doses have been administered. Spotted cracks on 8 occasions. Noticed that there have been 25 times where lids were loose and 40 times stains have been found on the bottles.

      This was reported to Fosun who communicated with the manufacturers. Manufacturers have not seen any major concerns but are investigating 20102 batch. 210104 - has not been opened.

      Plant/Manufacturing in Germany is being reviewed.

      Followup will be provided to the DH as soon as possible.

    • Second dose this Saturday will be affected - If we cannot resume vaccination, will take recommendations on the expert committee. 2nd dose should be administered at 21 day mark. It can however be administered between 19 and 42 days.

    • WIll request replacement ASAP. When the new batch arrived (if needed) the program will resume.

    • As of 8PM last night - 403K have received first dose, 150,200 have received BioNTech.

    • Incident handling is within protocols under DH guidelines. Vaccination program is suspended as a precautionary measure. In terms of quality and safety there are "no problems".

    • The notification was received this morning. Some people have arrived before the vaccination information was broadcasted. Appropriate measures are being taken.

    • Bookings are suspended for BioNTech vaccinations.



    Q&A:

    • What is the situation? Contamination? Leakage?

      The vial caps were loose in some situations - might have caused leakage. During the vaccination process - at vaccine centers there are experts who will do the dilution. The vial has to be diluted 5 times and due care is taken in this process. The needle / injection etc are examined carefully.

      If anything unusual is noticed - the vaccine / needle is disposed. Problematic injections are not used.

      Handling of drugs follows a stringent process - transport, arrival, storage, dilution and administering the vaccine is handled by professionals and is monitored.

      Manufacturer has said that there are no safety risks in this process.

      Vials with loose caps have been disposed.

    • Vaccines were not administered today? Was 210102 administered today even after suspension?

      Notice was received this morning and program was suspended. In the process there may have been some communication issues with some centers. 210102 is the only batch that has been opened and use.

      Those who have received the vaccine today is the same as the one been used before.

      The measure is precautionary - do not seen issues in terms of quality and safety.

    • How long will the investigation take?

      Investigation will proceed as quickly as possible. Involved German factory.

    • Will the defects affect the doses administered?

      No safety risks. The administration of the vaccine is safe - the vials are examined carefully before actual vaccination.

    • Press release was sent out at 10AM - why was it much later than Macau?

      Written notice was received from Fosun. Since two batches were delivered clarifications were needed from Fosun. Arrangements to suspend were made before the press release was sent out.

    • Will this delay the expansion of the vaccination program?

      The product can be stored for six months from manufacturing. Suspended removing vaccines from the -70 degree storage.

      Will monitor and make appropriate arrangements.

      Sinovac will continue. (No conspiracies please!)

    • Gatekeeping (?)

      Defects are checked for and reported back to the manufacturer. That is why the manufacturer has activated this suspension. This shows the checking is effective.

    • What was the exact time when HK received the notice?

      The notice was received from Fosun "this morning". Since there are two batches in Hong Kong (macau has one) - clarifications were needed from Fosun. Vaccination centers were notified after that and press release was issued around 10AM.

    • Is there a preliminary reason? Temp change? Logistics issues?

      All along we have a robust monitoring program. Batch 210102 - Feb 28th, 210104 - 7th of March. Cracked vials - 8 containers. 22 reports related to pressure. 16 loose caps and 11 (I think) stains.

      Manufacturer was notified and BioNTech has advised there is no safety risk. However, as a precaution they have requested suspension until the investigation is complete.

      BioNTech has also requested the second batch to be put on hold.

      According to the risk management plan - HK investigation will focus on logistics / storage chain. BioNTech will conduct inspections on the manufacturing process / plant.

    • Vaccine confidence

      Important to have open communication. There is a robust reporting and quality / expert committee / monitoring drugs. This is an example of reporting / quality control.

      The system is in place and is robust and there is continuous monitoring.

      This is a packaging issue.

    • If the DH noticed leaking / loose caps - why were the public not informed about this? How many vials have to be disposed / wasted today?

      Central storage will delivered to vaccination centers. They're in boxes and not opened. The CVCs will open the vaccines at sub-zero temperatures. There will be inspections and vaccines will not be used.

      We're not sure if the defects have occurred before or after reaching Hong Kong. The boxes were not opened until they have reached the CVCs.

      11,000 doses are in the vaccination centers. It is possible these doses might not be used.

    • Why were vials were delivered to the community centers?

      (See above) - Bottles cannot be inspected at the central storage. Several types of vaccines require dilution and these are always checked carefully by frontline staff - the handling is on par with other vaccines.

    • How many vaccinations were administered today? Refunds?

      In over 100K doses about XX defects were found and vials were discarded. This morning some centers started at 8AM. As of 11AM about 1080 doses were administered today.

      If the manufacturer says the vaccines are safe we will use. Else a replacement will be requested.

    • Are the vaccines checked for contaminants?

      Quality tests are done for micro-organisms - normal.

    • Some vaccination centers resumed after suspension

      There was some uncertainty on the suspension because of the two batches. 19 vaccination centers are involved and some were informed earlier than others. The suspension is a precautionary measure and there are no safety risks.

    • AstraZeneca or other brands?

      Delivery date is 2nd quarter as on the contract / advanced purchase agreement. No application for authorisation has been received. Data has not been provided.

    • Will you consider / recommend Sinovac for second dose?

      Recommended 2nd dose is 21 days. We hope to have report before the deadlines. Would recommend those who have recieved first dose TO WAIT. Switching brands is not recommended.

    Last edited by shri; 24-03-2021 at 03:22 PM.
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  3. #3

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    Govt Q&A press release:

    (Google Translate)

      The following is what the Secretary for Food and Health Prof. Chen Zhaoshi said in a meeting with the media before attending the Legislative Council meeting today (March 24):

    Reporter: When did the government actually receive the notification of Fubitel and when did the vaccination center be notified? Why is the message so confusing this morning, some say that it can be vaccinated, and some say it can't be vaccinated? After the authorities themselves receive the vaccine, do they have a random inspection mechanism to check the packaging and efficacy of the vaccine? Have you received any reports in the past few weeks that there is a problem with the vaccine cover?

    Secretary for Food and Health: The government received a written notice from Fosun Industrial (Hong Kong) Co., Ltd. Issues related to packaging defects need to be investigated. To be cautious, vaccination must be suspended during the investigation at this stage.

     
     So far, BioNTech and Fosun Pharma have not found any reason to believe that product safety is at risk. However, to be cautious, vaccination with batch number 210102 must be suspended during the investigation period until the end of the investigation. As for another batch of vaccine product No. 210104 in Hong Kong, it must also be sealed and will not be vaccinated temporarily. This is a preventive measure to ensure the safety of vaccination.

      In view of the fact that the Fubitai vaccine introduced in Hong Kong belongs to the above-mentioned batches, the community vaccination centers will temporarily suspend vaccination of Fubitai vaccine until further notice. Those who have made an appointment for vaccination with Fubitai vaccination from today do not need to go to the vaccination center for vaccination.

      Of course, we are very concerned about the incident, so the Department of Health has now held an emergency meeting with Fosun Industrial (Hong Kong) Co., Ltd. to further understand and follow up the incident. After receiving their notification, we have immediately notified different vaccination centers through the control center of the latest news. Now when the Department of Health and Fosun finish their meeting, there will be further explanations.

    Reporter: Will it be predicted how many citizens may be affected? Is it possible that some citizens may have injected the affected batch earlier and have risk problems?

    Secretary for Food and Health: Fosun Pharma told us that in fact they have no reason to believe that the current products have safety risks. However, they found some flaws in the packaging, so they need to investigate. For safety and precaution, we will not vaccinate them again until their investigation is over. At this stage, how many people have been vaccinated up-to-date? I don't have this figure on hand, but I believe that after the Department of Health and Fosun have a meeting later, when there is the latest report, they can be accounted for at that time.
    https://www.info.gov.hk/gia/general/...1032400391.htm

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  5. #5

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    I thought it was well handled. Hopefully this reduced the amount of shitposting about conspiracies.

    Time to remind people - "never attribute to malice that which is adequately explained by stupidity" - in this case "shit happened" and I guess extreme amounts of safety protocols / liability and other issues caused BioNTech to request a suspension pending investigation.

    Last edited by shri; 24-03-2021 at 03:37 PM.

  6. #6

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    thanks shri

    shri, chobochobo and Fiona in HKG like this.

  7. #7

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    Good luck with that

    Bartholomeuw likes this.

  8. #8

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    Yeah shit happens. It might be comforting for you guys to know, last month in Australia there was one doctor giving the same BioNTech vaccine, ovedosing his 90 year old patients in a nursing home with 4 times the dosage. I think he forgot one vial contained 4 doses or something stupid. Anyway they still survived, so hopefully you guys won't drop dead either

    shri, ThatOneGuy, timonoj and 5 others like this.

  9. #9

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    I wouldn't let a doctor give me a vaccination or any IM injection. My injection was almost painless.

    Fiona in HKG likes this.

  10. #10

    Agreed with Shri. Enough with the conspiracies, moaning and whining.

    The system is working. I am up for doing a Sinovac second dose if health dept seems it safe

    P.S I took Pfizer 2 days ago

    Last edited by Fatpigkenny; 24-03-2021 at 05:14 PM.
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