“Guatemala, like many other countries around the world, faces the same situation of vaccines due to expire and several countries have already found it necessary to discard vaccines due to expiration,” says a statement that the Ministry of Health published over the weekend, at the point that more than a million first-component Sputnik V vaccines are days away from expiration.
There are three batches of doses that entered the country on October 27 and 29, and were received with full knowledge that they would expire in four months.
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The rest of the doses against covid-19 available in the country do not have a long lifespan either, if the rate of vaccination is not accelerated, the waste of the biological will grow like a snowball, since more than 6.9 million doses from different pharmaceutical companies will expire in the short term. While only three out of ten Guatemalans have the complete vaccination schedule, and 66 percent of the municipalities are on red alert.
According to the report of the Ministry of Health, as of Friday, February 18, there was availability of 2 million 995 thousand 160 doses whose lifetime ends in March. Among this amount there is only a small batch of Moderna -2 thousand 860 doses-, the rest are Sputnik V of both components.
To expire in April there are 3 million 971 thousand 470 doses of different brands. The only ones that have a longer expiration date are from Pfizer that were purchased through the Covax Mechanism, these expire on June 30 and add up to 930 thousand doses.
It is ruled out that vaccines can be used after the expiration date, such as Deputy Minister of Primary Health Care, Edwin Montufar, had announcedsince the Department of Regulation and Control of Pharmaceutical and Related Products said in a report requested by Deputy Evelyn Morataya that “does not authorize extending the shelf life of vaccines against covid-19”. At the moment the World Health Organization does not support such a measure.
must be destroyed
The vaccines contemplated in the regular scheme, which are applied against diseases such as measles, polio, pneumococcus, among others, have an accelerated movement in the vaccination posts, since the demand is high. In addition to this, the personnel who work in the health centers point out that biologicals with a short life span are not received, in addition, they have the guideline to manage it quickly to prevent it from falling into disuse.
The same does not happen in the inoculation against covid-19, since the flow has been slow and the expiration date of the dose that entered the country is short. So what will happen to this biologic when it expires? According to the protocol of the Ministry of Health, expired and disused medicines and related products must be written off and destroyed. This includes vaccines against coronavirus.
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The ministerial agreement 534-2011 establishes that the destruction of the same is under the responsibility of the executive directors of the dependencies and executing units of the Ministry of Health.
As part of the process, a record must be drawn up stating “the reasons why the drugs and related products were not used within the period of validity.” The document must record the facts and circumstances regarding whether or not there is a person responsible for its expiration.as well as product data -presentation, expiration date, unit price, total cost-.
The rule establishes that one or more persons may be responsible for the expiration of the drugs when it is verified that “there was intent, fault, action, omission or negligence in their use, within the period of their useful life”.
In this case, the agreement indicates that the culprit or culprits must replace or pay the value of the expired product. If there are no stocks in the local market, payment must be made in cash in a specific account in the Bank of Guatemala, in the name of the Government of the Republic, Common Fund.
Responsibilities
For the lawyer and director of Citizen Action, Edie Cux, in this case there is a chain of command established in the Ministry of Health that must respond for the loss of vaccines that may occur in the coming days.
In addition, it points out that public officials are accountants, which implies that they have responsibilities, which continue even 20 years after leaving office.
To clarify who or who are directly responsible for the possible deterioration of the biological, Cux sees it necessary for the Comptroller General of Accounts to take its active role and carry out the respective audit to establish it.
The most worrying thing, according to the lawyer, is that there is still no clarity about the contract that was signed with Human Vaccine, in which Guatemala would have the commitment to buy another 8 million doses of Sputnik V. “It is unfortunate that so much resource is lost due to the negligence of the authorities of the Health System”, he adds.
How are they disposed of?
The Regulation for the management of hospital solid waste classifies expired or unused vaccines as bioinfectious hospital waste, and for their destruction these must be incinerated or use another system authorized by the Ministry of Health.
While syringes must be destroyed by means of a shredding or heat-shredding machineor packed in cardboard boxes or appropriate plastic containers, closed and sealed, and deposited in red bags or containers with the bioinfectious symbol to place them among hospital waste.
loss of biological
Due to the interruption of Cold chain 3,940 doses against covid-19 of different brands have been lost in the health areas of Chimaltenango, Escuintla and Quetzaltenango. The instability of the electricity supply at the points where the biological is stored in the province means that the vials are not kept at the temperature suggested by the manufacturer.
In the report requested by Deputy Morataya from the Ministry of Health on the expiration of the vaccines, it also mentions that as of January 5, a total of 7,895 doses could not be used because they expired. The report is from Izabal, Quetzaltenango, Sololá, Totonicapán and Guatemala Nor-Oriente.
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Intensify vaccination
The Ministry of Health reported that in order to advance the National Vaccination Plan, an inoculation intensification day against covid-19 will be held in the country’s 340 municipalities from February 21 to 28, and priority will be given to those with low coverage. He mentions that with a similar action carried out weeks ago, 700,000 doses were applied in nine days. The strategy seeks to prevent the biological from being wasted.
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