Govt. re-recommends COVID-19 regulations: Medics, legal experts warn of vaccine expiry dates and injuries



Statistics reveal that only eight million out of 14.4 million people over 20 years of age have received the booster vaccine.

 

The public has once again been advised to wear masks to prevent the spread of COVID; especially after two COVID-related deaths were reported on July 25. Medical experts warned of a surge in daily COVID cases and advised the public to continue following health regulations that were introduced to prevent the spread of disease. On the other hand, Chief Epidemiologist Dr. Samitha Ginige said that a future COVID wave might impose a risk on people who haven’t received the vaccines. 
 
Mask and vaccine mandate back?
 
In a letter dated June 6, 2022, Director General of Health Services Dr. Asela Gunawardena said that it is not mandatory to wear face masks indoors or outdoors and that performing COVID PCR tests or Rapid Antigen Tests shouldn’t be done as a screening test. However, a little over a month later, the health authorities recommended the public to wear facemasks when remaining indoors, using public transport and at public gatherings. 
On Tuesday (July 25), Dr. Ginige said that clinical tests conducted across the country have revealed that people who received the booster vaccine have been prevented from further infections, complications or death. However statistics reveal that only eight million out of 14.4 million people over 20 years of age have received the booster vaccine. 
 
Vaccine expiry dates extended 
 
A circular with the subject ‘Extension of shelf life of available batches of COMIRNATY-COVID-19 mRNA vaccines (Nucleoside modified – Pfizer BNT) as per the recommendation of WHO’ was issued on July 22, 2022. This document states that the recommendation on the shelf-life of the COMIRNATY COVID-19 mRNA vaccine has been extended from 9-12 months for unopened vials stored at temperatures between -900C to -600C. Therefore the National Medicines Regulatory Authority has conveyed its recommendation that the shelf life of the following batches (see image) of the COMIRNATY COVID-19 mRNA vaccine received by Sri Lanka can be extended until October 31, 2022 provided that the approved storage conditions have been guaranteed throughout the supply chain of the product. 
 
 
The people who took the vaccine are already suffering long-term complications such as premature tiredness, loss of memory, listlessness, diabetes, blindness, hearing difficulties, inability get about their daily chores, and also sexual disability in both partners
-Tirantha Walaliyadde President’s Counsel
 
 
Medical unions call for investigation
 
In response to the aforementioned circular, medical unions have called for investigations on extending expiry dates as well as importing excess vaccine stocks. “There’s a huge stock of unused vaccines and as means of using these vaccines the Health Ministry has taken steps to extend the expiry dates of these vaccines,” opined Association of Health Professionals President Ravi Kumudesh. “According to NMRA regulations, scribbling on an expiry date is illegal and is a punishable offence. But already the Health Services Director General has advised to scribble on the vaccine expiry dates and extend it by three months.
 
“Even though a vaccine could be used in this manner, after analysing its long term data, what is most suitable is to use a vaccine prior to its expiry date. We raised concerns about the NMRA’s attempts to import large stocks of the Pfizer vaccine. However it is easy to purchase Pfizer vaccines and competitive prices too have reduced now. We have learned that there’s a large number of unused Pfizer vaccine stocks and the authorities are planning to provide these vaccines to the public as that is the only option available,” Kumudesh added. 
 
He further said that the decision taken to extend the expiry date has been taken to ensure that the Pfizer vaccine stock- which has been imported at a cost of USD 4 million- doesn’t go to waste. “It is the duty of the procurement committee to ensure that any medicine or pharmaceutical has a shelf life of 24 months within which these items should be used,” he added. 
 
 
What is most suitable is to use a vaccine prior to its expiry date. We raised concerns about the NMRA’s attempts to import large stocks of the Pfizer vaccine. However it is easy to purchase Pfizer vaccines and competitive prices too have reduced now
- Ravi Kumudesh Association of Health Professionals President
 
 
 
Vaccines, a risky business?
 
However President’s Counsel Tirantha Walaliyadde - who has been quite outspoken on the adverse effects of vaccines on his social media channels- opined that the extension of the date of expiry has been initiated by the manufacturers. Following are excerpts of an interview done with Walaliyadde. 
 
Q  There’s concern regarding the expiry date of vaccines. The date has been extended by three months and according to a circular the vaccines should be stored under specific storage conditions. In the instance of a citizen suffering complications as a result of the vaccine could he or she file action against the Health Ministry?
 
The fact that the date of expiry has been extended by manufacturers itself raises a question regarding bona fides. Also, the Health Ministry is rather vague about any or what testing has been done to justify such an extension and, in any event, no proper and exhaustive testing has been done in Sri Lanka; even before the extension.
 
Q   Can the state be held accountable for vaccine injuries/ deaths? 
 
*The people who took the vaccine are already suffering long-term complications such as premature tiredness, loss of memory, listlessness, diabetes, blindness, hearing difficulties, inability get about their daily chores, and also sexual disability in both partners. Dr. Hemantha Herath, during the initial stages of the vaccination programme, specified that he could not rule out sexual disabilities after vaccination. Also Dr. Fernandopulle, then Minister of Health, went into tantrums when the specific question was forwarded by Mr. Chamuditha Samarawickrema at an interview, after which there was a severe drop in vaccinations among the youth. This was the main reason why the Health Minister tried to introduce legislation making vaccination cards mandatory to enter public places- it was observed mainly in the breach and was stifled. 
 
*Thereafter the Health Minister created a fear psychosis among the public by publishing increasing numbers of allegedly covid related deaths. Then he drove panic into parents by reporting about increasing infections among school children. There was also an attempt to coerce the children into taking the vaccine by attempting to make vaccination cards mandatory in order to get admissions and sit for examinations.
 
All this failed and the majority of youth refused to take the vaccination.
Thereafter the Minister started making arrangements for the vaccination of 12-16-18 year range and also 2-12 year range and pregnant mothers- without one iota of clearance in Sri Lanka as regards to the long-term disabilities of the vaccine.
The vaccination programme came to a standstill. 
 
"According to NMRA regulations, scribbling on an expiry date is illegal and is a punishable offence"
 
Then the demonstrations and protests were started by political parties and the public where thousands gathered on the streets without any mask or any vaccination cards. Begging and pleading with the striking Trade Unions schools reopened without vaccination cards, general staff entered school premises without any vaccination cards and in the meantime Dr. Asela Gunawardena, Director of health Services made an announcement that there was no need to produce any vaccination card to sit for the O/L and A/L examinations.  Recently, wearing of masks was scarcely seen with regard to the Galle Face protesters and spectators at the Australia-Sri Lanka Test matches. None of these massive gatherings resulted in an outbreak of COVID. 
 
  • This is a brief summary of the fears that were instilled in the public by the Health Department in their frantic attempts to get rid of the vaccines that were rotting away. These drugs were imported at an unbearable cost and they are one major contributory factor connected to the current financial crisis.
 
As precautionary measures a short period is given as its shelf life. Initially the shelf life was given for three months, the next batch for six months, the other batch for nine months and so on. So they have found that the existing batches are still potent
-Dr. Hemantha Herath Deputy Director General of Health Services 
 
 
 
Q  The COVID vaccines were produced for emergency use, but the government at one point forced people to get the vaccine by mandating vaccination cards. Even though several cases were filed against mandating vaccination cards etc., these cases were dismissed. What are your observations on these incidents?
 
The dismissal of the cases was the obvious result of irresponsible filing of cases and inviting the Supreme Court to hold against the World Health Organisation in a pandemic situation which terrified the whole world. So also, I refused to get involved because had the Supreme Court ruled that there was no violation of Fundamental Rights then it would have given the mandate the Health Authorities were after for mandatory vaccinations. So, it was fortunate that the Supreme Court dismissed the applications without granting leave to proceed.
 
"Statistics reveal that only eight million out of 14.4 million people over 20 years of age have received the booster vaccine"
 
 
The problem arises with the inability to prove the direct nexus between the vaccine and the causing of death or disabilities. I speak only having regard to the probabilities of consequences having regard to the statistics and not with direct proof that the vaccination caused the disabilities. The fact that no reasonable testing was done, that no follow up was done after vaccinations with regard to long-term side effects- and still not done-, the reluctance of those affected sexually to make such declarations in public, as well as the fact that many people had encountered severe complications after vaccination are unchallenged. 
 
A main obstacle that is faced in prosecution is that such proof has to be obtained via western medical sources and the Government Laboratories which have the capacity for such testing and also the apathy of people who have been affected in the face of the current crises facing them.  The proof has to be obtained by testing volunteers and would take a considerable period of time and at the rate the Government machinery shifts its gears here, well, the people would prefer to suffer in silence.
I can only warn the public that the taking of the vaccine is a risky business and irreversible damage can be caused to you and yours. I cannot tell them not to take the vaccine.
 
Health authorities recommended the public to wear facemasks when remaining indoors, using public transport and at public gatherings
 
 
Expiry dates extended by manufacturer; no complaints on vaccine injuries – DDGHS
 
However, when contacted, Deputy Director General of Health Services Dr. Hemantha Herath said that the extension of the expiry date was done by the vaccine manufacturer. “As precautionary measures a short period is given as its shelf life. Initially the shelf life was given for three months, the next batch for six months, the other batch for nine months and so on. So they have found that the existing batches are still potent and that they could be used for another three months. This was then communicated to the World Health Organisation and based on that information the WHO expert committee had rectified that these vaccines can be used. They have then informed the MOH and NMRA- who had also reviewed the information- and has confirmed that the specific batch has the potency to be extended for another three months. The expiry dates of three batches will be extended this way, but we will have to throw away any other remaining stocks,” said Dr. Herath.
 
When inquired if there were complaints regarding vaccine injuries and deaths following COVID vaccinations, Dr. Herath responded in the negative. He went on to explain that only as little as 15,000 people have taken the fourth dose as of now. “We therefore don’t have the exact calculations, but health workers are required to record any form of vaccine injuries or complications mentioned by patients. However there have been no major reactions among people following the fourth dose,” said Dr. Herath. 



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