Fosun BioNTech Batch No 210102 – Update

At today’s daily press conference the Secretary for Civil Service Patrick Nip said the Hong Kong Government had received notice from Fosun Pharma/BionTech that there may be a problem with the packaging with Comirnaty batch number 210102.

BioNTech requested that vaccinations stop during the investigation period, while stressing that this is just a precaution. The Department of Health (DoH) and the CHP have decided that all local vaccinations in Hong Kong using Fosun BioNTech vaccine known as Comirnaty will stop until further notice. 

Director of Health Dr. Constance Chan said the DoH has stringent protocols to monitor the distribution of medications locally.

Hong Kong has imported two batches of BioNTech vaccine:
585,000 doses on 28 February 2021 – Batch Number 210102.
758,000 doses on 7 March 2021 – Batch Number 210104.
150,000 doses from batch number 210102 have been used as of 23 March.

Dr. Chan said since these vaccinations have begun health staff have filed the following reports:
8 incidents when staff found cracks in the container.

22 incidents of leakage due to overpressure in the vile.

16 incidents of loose caps or caps that were not straight were found.

8 incidents where marks or dirt were found on the bottle

To be extra cautious whenever staff found abnormalities, they did not use these viles and threw them away.

Dr. Chan commented that those who have been vaccinated should not worry as there are very strict protocols for the staff to follow. This was echoed by Secretary for Food and Health Professor Sophia Chan who wanted to remind people that there is no evidence of any problems with the doses already administered to people in Hong Kong.

Thru their distributor Fosun Hong Kong, the Government submitted feedback to the manufacturer BioNTech. The manufacturer recommended Hong Kong suspend use of Batch Number 210102 temporarily. Batch Number 210104 is still in the warehouse and Fosun recommended that this batch not be used for the moment too. Dr. Constance Chan said that they will await the report from BioNTech as to whether batch 210104 can be used. If not, this batch will be returned, and HKGOV will request a new batch from BioNTech.


This morning an investigation was launched by the DoH. Fosun will request BioNTech to review the procedures inside their manufacturing plant. While locally Fosun will review the arrival procedures to see if their handling in Hong Kong had anything to do with these events.

Beyond those waiting for their first dose are those waiting for the second dose. The first group of which are scheduled for this Saturday, 27 March. The DoH is pressuring BioNTech for a prompt response and report.  Currently, the DoH procedure is to administer the 2nd doses on day 21. Although there are studies and recommendations that suggest the second dose be effective up to Day 42. Dr. Chan said the DoH preference is to continue with day 21 but this all depends on what the manufacturer says.

Statement from Fosun Pharma

Fosun received written notice from BioNTech on the evening of 23 March 2021 informing them that there may be a “small number of defects related to the cap of the vial” in batch number 210102.

Fosun added that “As, at the date of this announcement, there is no evidence to suggest that the safety of the relevant batches of product may be at risk.”

Updated Social Distancing Measures – 18 February, 2021

Today the government updated the gazetted directions and specifications under the Prevention and Control of Disease (Requirements and Directions) (Business and Premises) Regulation (Cap. 599F) to further tighten social distancing measures.

The updated directions are effective from 00:01, 18 February, 2021

Restaurants

Allowed to open to 10pm and a maximum of 4 persons will be allowed per table. Staff to ensure that customers… 

    • Wear masks 
    • Check their temperature
    • Do not allow more people than permitted 
    • Use hand sanitiser 
    • Make sure people are socially distanced. 
    • ALL patrons may only enter if they have scanned using the Leave Home Safe app or leave with the outlet their last name, mobile phone number and the time that person entered and exited the premises. All records must be kept for 31 days. 
    • Restaurants must also ensure that all working staff members are tested every 14 days. All test records must be kept for 31 days. 

For those restaurants that have not complied with all of the new conditions, these outlets will only be allowed to open till 6pm and a maximum of two people will be allowed on each table. 

Restaurants that fail to comply with these new rules could be fined up to HKD 50,000 or imprisoned for up 6 months. 

Premises That May ReOpen:
    • All sports ground both indoor and Outdoor 
    • Beauty parlours
    • Gyms
    • Massage parlours
    • Cinemas 
    • Amusement parks 
    • Video Game Centers 
    • Ice Skating Rinks
    • Bowling Alleys 
Premises That Remain Closed:
    • Party Rooms
    • Bathhouses 
    • Discos/Night Clubs 
    • Karaokes 
    • Mahjong Parlors
    • Swimming Pools
    • Beaches 
Public Gatherings:
    • No more than 2 persons can gather together at any one time.

Government Raises Penalties for Offences under Cap.599

The Government has announced it will gazette amendments to the subsidiary legislation under the Prevention and Control of Disease Ordinance (Cap. 599), increasing the penalties for breaching the relevant Regulations. The amendments/ new fines will take effect from 11 December, 2020. 

A spokesman for the Food and Health Bureau said, “Anti-epidemic work requires the cooperation and self-discipline of all citizens by strictly complying with various anti-epidemic measures, including avoiding crowds, keeping social distance and maintaining personal hygiene… Faced with the epidemic surge, apart from tightening various infection control measures, it is imperative to increase the relevant penalties in order to create the necessary deterrence effect and ensure strict compliance with relevant requirements.”

The penalties amended under relevant Regulations are as follows:

Prevention and Control of Disease (Prohibition on Group Gathering) Regulation (Cap. 599G) 

Any person who participates in a prohibited group gathering commits an offence. The fixed penalty for discharging liability for the offence is raised from $2,000 to $5,000;

Prevention and Control of Disease (Wearing of Mask) Regulation (Cap. 599I) 

Anyone who fails to wear a mask in accordance with the requirement when boarding or on board a public transport carrier, entering or present in an MTR paid area, or entering or present in a specified public place (currently covering all public places, save for outdoor public places in country parks and special areas as defined in section 2 of the Country Parks Ordinance (Cap. 208)) commits an offence. The fixed penalty for discharging liability for the offence is raised from $2,000 to $5,000. The maximum penalty upon conviction is raised from a fine at level 2 ($5,000) to level 3 ($10,000). 

Prevention and Control of Disease (Compulsory Testing for Certain Persons) Regulation (Cap. 599J)

Anyone who fails to comply with a requirement of a compulsory testing direction or a compulsory testing notice commits an offence. The maximum penalty upon conviction is raised from a fine at level 1 ($2,000) to level 3 ($10,000). The fixed penalty for discharging liability for the offence is raised from $2,000 to $5,000. 

The spokesman emphasised that the Government will step up inspections and law enforcement, taking stringent enforcement actions against offenders. If compliance is not satisfactory, the Government does not rule out the possibility of further raising the penalties.

The spokesman added “At this critical juncture of anti-epidemic work, we need the collective efforts of the community to keep social distance and maintain personal hygiene, in order to protect ourselves, our families and the public at large, especially the high-risk and disadvantaged groups. Accordingly, the Government strongly urges all members of the public to stay at home as far as possible and stop all unnecessary social activities. We are confident that with solidarity and concerted efforts of all, we should be able to fight this wave of epidemic together with a view to resuming normal economic and social activities.”

Updated Social Distancing Measures – 2 December, 2020

Today the government updated the gazetted directions and specifications under the Prevention and Control of Disease (Requirements and Directions) (Business and Premises) Regulation (Cap. 599F) to further tighten social distancing measures.

The updated directions are effective from 00:01, 2 December for 14 days

Civil Servants:

Civil servants are to work from home. Other than those who are providing essential or emergency services everyone have to remain at home.

CE is urging all private businesses to follow in the footsteps in the government and allow staff to work from home.

Premises that need to close:

Video Game Centers
Cinema
Playgrounds
Karaokes
Swimming Pools
Mahjong Parlors

Premises allowed to remain open:
  • Gyms and exercise centers (No more than 2 people can participate in any activity)

  • Massage and beauty parlors (They must keep up with strict hygiene rules set out by the government)

Restaurants:
  • Restaurants must all close by 10pm.

  • No more than 2 persons per table (From 4 persons)

  • Restaurant capacity will be limited to 50%

Public Gatherings:
  • No more than 2 persons can gather together at any one time.

Penalties and Fines:

Government looking at increasing penalties and fines for offenses related to Cap 599.

Updated Social Distancing Measures – 24 November

Today the government updated the gazetted directions and specifications under the Prevention and Control of Disease (Requirements and Directions) (Business and Premises) Regulation (Cap. 599F) to further tighten social distancing measures.

The updated directions are effective Thursday 26 Nov at 00:00 until 2 Dec at 23:59hrs

  1. Bars must close
  2. Nightclubs must close
  3. Bathhouses must close
  4. All Live music and dancing is prohibited even at weddings etc.
  5. There must be no more than 40 persons at any type of catering venue. Maximum will be 10 tables with 4 people to a table for all banquet venues. This is applicable to all clubs and hotels too.
  6. Restaurant capacity may not cross 50% of capacity.
  7. All persons must wear masks when not eating and getting up from their seats at restaurants.
  8. Hotels must make sure that if they have quarantine guests these guests must be separated from guests who are not under quarantine.
  9. Hotels have a responsibility that guests in quarantine cannot leave their rooms.
Feeling Unwell

If you feel unwell go to a doctor or the hospital – call ahead first, so as not to risk the stff.

Do not go to the local testing centers. These are for people with no symptoms.

Contact Tracing

To improve contact tracing all restaurants must apply for a QR code for use with the LEAVE HOME SAFE APP from the government by 2 December. This QR code must be displayed at entrances of restaurants.

More information on the leave home safe app can be found at the website below:

https://www.leavehomesafe.gov.hk

The government will use 599F to make sure that restaurants and other designated venues apply for this QR Code and post up a label within two days.

Government Further Tightens Social Distancing Measures – 21 November

Today the government updated the gazetted directions and specifications under the Prevention and Control of Disease (Requirements and Directions) (Business and Premises) Regulation (Cap. 599F) to further tighten social distancing measures. The updated directions will take effect at 0.00am on November 22 and last for 5 days

The details of the updated tightening measures are as follows:

  1. Live performance and dancing must not be allowed in any catering premises (including bars or pubs) as well as clubs or nightclubs.
  2. Premises (commonly known as party rooms) that are maintained or intended to be maintained for hire for holding social gatherings must be closed.

Persons responsible for carrying on catering businesses and managers of scheduled premises that contravene the statutory requirements under Cap. 599F would have committed a criminal offence. Offenders are subject to a maximum fine of $50,000 and imprisonment for six months.

The full government press release can be read here.

Attached is a summary of the latest measures that relate to catering business and scheduled premises

[gview file=”https://www.bcmagazine.net/wp-content/uploads/2020/11/summary-of-restriction-21-nov-2020.pdf”]

Update on Social Distancing Guidelines…

Professor Sophia Chan, Secretary for Food and Health has announced new and updated Social Distancing Guidelines, Mandatory Testing Rules and Airport testing for those from High Risk Countries that are effective on November 16th at 0001hrs till November 26 at 2359hrs.

Restaurant and Bars:
  • Restaurant dining hours will be from 0459-2359hrs.

  • No more than 4 people may be seated on one table at restaurants.

  • No more than 2 people may be seated at one table in bars, pubs and nightclubs.

  • Masks must be worn when not drinking or eating.

  • Bars and Restaurants will be required to only operate at 50 per cent of seating capacity.

Sportsgrounds:
  • Masks must be worn when exercising indoors including public skating rinks except when here is a distance of 1.5 meters or doing exercises with little physical contact.
  • Swimming pools will be limited to 50% Capacity.

Hotels and Guesthouses:

The government is looking to imposing new requirements that include:

  • Limiting the number of guests in each room to no more than four persons. (Those living in the same household will be exempt).

  • Requiring all visitors to guests rooms to register personal details with the hotel before going to visit a room.

  • Temperature checks of all guests entering the hotel.

  • Hotel and Guesthouses must arrange for cleaning and disinfection of all rooms after each check out.

  • Make hand sanitizers available for all guests.

  • If the hotel accepts quarantine guests, these guests must be separated on separate floors.

  • The responsibility that quarantine guests do not leave their rooms during their quarantine period.

  • In addition, the government is also looking to tightening the rule on deliveries for any person in quarantine.
  • If the person in quarantine needs food or games or anything from home these items can be placed outside the door of the guest room on the basis there is no face to face contact.

  • If the person in quarantine (such as a minor) requires the company of a carer (with prior permission from Department of Health), this person will be treated like a quarantined person. The carer will not be allowed to leave the room and must remain inside until the end of the quarantine period.

Group Gatherings:
  • Group gatherings can not be more than 4 people.
Mask Wearing Requirement:
  • There are no changes in the mask wearing rules.
Compulsory Testing Cap 599J:

This additionally gazetted caption allows the government the right to impose compulsory testing.

  • This type of testing may be used to test persons who work or live in the same place as a confirmed person. The government may also use this regulation to test individuals who work in a particular occupation or even those to provide a day 12 test when arriving back in Hong Kong from abroad.
  • Individuals who are required to be tested under 599J can either choose to be tested by the Department of Health or a private laboratory.
  • Any person who does not comply with the testing notice will be fined HKD 2000.
  • A further compulsory testing order will be issued for a person to be tested within a specific timeframe. Failure to comply will result in a fine of HKD 25,000 and 6 months imprisonment.
Arrivals from High Risk Countries:
  • All persons including Aircrew arriving from countries designated as high risk must be tested for Covid-19 upon arriving in Hong Kong. Everyone from these countries including aircrew have to wait for their results at a location designated by the government.
High Risk Countries currently designated include:
  • Bangladesh, Belgium, Ethiopia, France, India, Indonesia, Kazakhstan, Nepal, Pakistan, The Philippines, Russia, South Africa, Turkey, United Kingdom, United States of America
Banning of Flights:
  • Currently, there is a rule set when 5 or more or 3 people on two flights test positive the government suspends the airline and flight for 2 weeks. Professor Chan said the government is looking at reviewing this rule and may change the threshold as well as the length of the ban. There has been no decision on this matter yet.