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MOPH accelerates vaccine registration, allowing private sector to import COVID-19 vaccines


snoop1130

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MOPH accelerates vaccine registration, allowing private sector to import COVID-19 vaccines

 

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BANGKOK (NNT) - Dr. Narong Saiwong, the Deputy Permanent Secretary and spokesperson of the Ministry of Public Health (MOPH), dismissed a claim that the importation of two million doses of the COVID-19 vaccine from AstraZeneca is unfair to private hospitals, because the volume is too small and those receiving the vaccine are in a limited range. Also, the private hospitals which order vaccines from other companies still can’t import them, because the Food and Drug Administration (FDA) has not yet registered them and it is considered a risk to preventing the spread of COVID-19.

 

He said the FDA insisted that registration of the COVID-19 vaccines has not been delayed, but adheres to safety and quality standards. The documents must be complete because it is a product related to the life of the people. The FDA has fully facilitated the registration of the COVID-19 vaccines by mobilizing internal and external experts to consider them, so that the vaccines can be approved as soon as possible. It is not possible to relax regulations or reduce supervision because it is a product related to people’s lives.

 

For AstraZeneca’s COVID-19 vaccine, the FDA received registration application documentation on December 22, 2020, and sent it to experts to assess and approve the vaccine registration on January 20, 2021. The consideration took about one month. The vaccine, registered by the FDA, has been approved for emergency use. It is necessary to have a system for continual supervision and monitoring. Currently, two companies, namely AstraZeneca (Thailand) Co., Ltd. and Sinovac Biotech Co., Ltd., have submitted applications for registration of their COVID-19 vaccines through the Government Pharmaceutical Organization (GPO). The FDA is waiting for additional documents. It confirms that it is not preventing any company from applying for registration of their vaccine and is ready to provide advice and answer questions to facilitate the registration.

 

The GPO has purchased two million doses of COVID-19 vaccine from Sinovac Biotech Limited, from the People’s Republic of China, which has already applied for registration by the FDA. The FDA is gathering additional information. The GPO will purchase amounts of vaccine according to the Department of Disease Control’s demand. The vaccine will be distributed in accordance with the national allocation plan. The provision of COVID-19 vaccines must be done carefully and is subject to global demand. Moreover, the existing vaccines have just entered the production process and there is a high global demand. It is now known that other private companies have also applied for registration of vaccines from Chinese manufacturers.

 

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-- © Copyright NNT 2021-01-26
 
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14 hours ago, snoop1130 said:

It is now known that other private companies have also applied for registration of vaccines from Chinese manufacturers.

How many other Chinese vaccine's are there other than the main Sinovac one..........?

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14 hours ago, snoop1130 said:

because it is a product related to the life of the people

Yeh sure ... if you don't get vaccinated the chances are you'll get Covid and possibly die ... on the other hand ... if you do get vaccinated the chances are you won't get Covid and not die ... makes sense really 

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At this stage, while they have limited supply and are under pressure to supply existing orders on time, Pfizer and Moderns are not going to waste their time and money with the notoriously corrupt Thai FDA without a substantial government order to ease the registration process. The GPO another, corrupt government entity, is responsible for handling the registration of AZ and Sinovac because the government ordered them.

 

If the pharmas want to sell to private hospitals there will have to get their local offices to do or have a local drug company do it. Someone needs to consolidate a large order from private hospitals to get this done.

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10 minutes ago, Dogmatix said:

At this stage, while they have limited supply and are under pressure to supply existing orders on time, Pfizer and Moderns are not going to waste their time and money with the notoriously corrupt Thai FDA without a substantial government order to ease the registration process. The GPO another, corrupt government entity, is responsible for handling the registration of AZ and Sinovac because the government ordered them.

 

If the pharmas want to sell to private hospitals there will have to get their local offices to do or have a local drug company do it. Someone needs to consolidate a large order from private hospitals to get this done.

I just read the US and Europe are trying to prevent the jabs from being exported.  Sadly.

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1 hour ago, topt said:

How many other Chinese vaccine's are there other than the main Sinovac one..........?

Two other covid-19 inactivated vaccines.  (ref. Prnewswire, April 15, 2020)

Plus two earlier developed vaccines unrelated to covid-19 (one a rabies vaccine?) using the same inactivated virus technology.

 

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If private hospitals are allowed to obtain their own vaccines, and sell them to the public, how is it going to be possible to have any understanding country wide as to who has received the vaccine.

It seems inevitable that vaccine passports are going to be required before any sort of mass international travel is going to be allowed. Talks are already ongoing as to how this is best implemented, and in what form. It is likely to be an app, which makes you wonder how Thailand is likely to approach this given their obsession with paper forms in the public sector.

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