BioNTech vaccine given emergency use authorization in HK; first 1 mln doses to be delivered in Feb
Published: Jan 25, 2021 07:55 PM

A staff member introduces a potential COVID-19 vaccine developed by BioNTech and Fosun Group at the Medical Equipment and Healthcare Products exhibition area during the third China International Import Expo (CIIE) in Shanghai, east China, Nov. 5, 2020. (Xinhua/Zhang Yuwei)

The COVID-19 mRNA vaccine developed by BioNTech was approved for emergency use in China's Hong Kong Special Administrative Region on Monday. 

According to the Hong Kong regional government's website, the Hong Kong Food and Health Bureau approved emergency use authorization for the vaccine, BNT162b2, as a local experts' committee suggested the authorization is necessary considering the current threat to Hong Kong society brought by the coronavirus. 

The number of COVID-19 cases in Hong Kong since the pandemic began a year ago surpassed 10,000 on Saturday and the region is still grappling with a resurgence of the virus, which has entered a fourth wave.

Hong Kong's Center for Health Protection reported 81 confirmed cases at a press briefing Saturday, taking the total to 10,009.

The government announced Saturday that a virus-stricken area in the Kowloon Peninsula will be locked down for two days, and all residents will be required to take compulsory tests and stay at home until test results are mostly known.

The emergency use authorization took effect on Monday and requires the vaccine maker to continue to submit new data on the vaccine's clinical trials and safety, and provide a quality certificate for every batch of product, according to the announcement. 

The announcement said that the first batch of the vaccines, about 1 million doses, has finished production and are undergoing safety and quality review. 

The first batch of vaccines is expected to arrive in Hong Kong in late February if the review procedure goes smoothly, following which Hong Kong government will kick off a local mass vaccination plan, read the announcement.   

On December 11, the Hong Kong regional government announced that it had reached an agreement with Fosun Pharma, the Chinese partner of German vaccine producer BioNTech's BNT162b2 vaccine, to purchase up to 7.5 million doses of the mRNA COVID-19 vaccine BNT162b2.

Pfizer is BioNTech's partner outside China. 

Recent reports of the Pfizer vaccine allegedly leading to serious side effects such as facial paralysis and even death, and reports the vaccine has lower efficacy than trial data, have caused concerns over the vaccine's safety and efficacy.    

In response to the concerns, the Hong Kong government said in the announcement that the local experts' committee had noted these reports and some common side effects of vaccines may affect people who have serious diseases or are in poor health. 

Based on experts' suggestions, the Hong Kong Food and Health Bureau required the supplier to provide related documents to draft matters needing attentions for local vaccination. 

The experts' committee will also pay close attention to potential side effects during vaccination, read the government announcement. 

After reviewing available information and data on deaths reported in frail, elderly individuals who had received the Pfizer BioNTech COVID-19 mRNA vaccine, the World Health Organization (WHO) said in a statement on Friday that the current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of BNT162b2. 

Reports are in line with the expected all-cause mortality rates and causes of death in the sub-population of frail, elderly individuals, and the available information does not confirm a contributory role for the vaccine in the reported fatal events. 

In view of this, experts invited by the WHO to review these reports consider that the benefit-risk balance of BNT162b2 remains favorable in the elderly, and does not suggest any revision to the recommendations around the safety of this vaccine.

Fosun launched Phase II clinical trials on BNT162b2 on November 24 in Taizhou and Lianshui, East China's Jiangsu Province. The company previously told the Global Times that they would not launch Phase III clinical trials in China as the epidemic has been controlled in the country and there are not enough potentially infected people for Phase III trials.  

International Phase III clinical trials have shown that the vaccine BNT162b2 has 95 percent efficacy in preventing infections of the coronavirus and its efficacy for people aged above 65 is more than 94 percent, Fosun Pharm said in a statement sent to the Global Times on Monday.

The vaccine shows consistent efficacy in different ages, genders, nationalities and populations, read the Fosun statement.  

The BioNTech vaccine is reportedly the first COVID-19 vaccine to obtain the World Health Organization's emergency use authorization. The authorization was announced on December 31. 

So far, the vaccine has been authorized by regulatory agencies in more than 50 countries and regions, including the UK, the US, Canada and EU, according to Fosun's statement.