Vaccines donated by the Covax Foundation with expiration date arrive soon

Equal access to Covid-19 Vaccines Countries are one of the main challenges in facing the epidemic. The World Health Organization (WHO) warns that while rich countries focus on developing and procuring up front immunization agents, middle and low-income countries, especially in Africa, are lagging behind in their vaccination campaigns.

Epidemiologists point out that as long as there are sites with Gaps in immunization, the entire world will remain at risk due to the possibility of new variants emerging that could be more resistant to the available vaccines.

“When you start vaccinating the world unevenly, for example, advance vaccination coverage in Europe, the United States, and Brazil, but you don’t vaccinate anything at all in sub-Saharan Africa and in very low-income countries, we may have epidemics in these places. and appearance Virus genetic variants in these locations,” says Alvaro Furtado, an infectious disease specialist at Hospital das Clinicas at the University of São Paulo (USP).

According to infection doctor Julio Croda, from Oswaldo Cruz Foundation (Viocruz), Big Pharma’s lack of interest in negotiating with poor countries exacerbates the scenario.

In addition, the high cost of vaccines against the new coronavirus makes many countries rely on initiatives such as the Covax Facility Consortium to obtain immunity.

Shelf life of donated vaccines

This week, WHO Director of Vaccines, Kate O’Brien, warned that vaccines being donated to the WHO Kovacs facility by rich countries with a relatively short expiration date, which was a problem for the consortium.

For epidemiologist Carla Dominguez, former coordinator of the National Immunization Program (PNI), donating vaccines must take into account the different profiles and logistical capabilities of countries receiving immunizing agents.

What we are seeing is the donation of vaccine leftovers, which is not possible. The donation should be designed so that countries have time to prepare the logistics of distribution. Otherwise, it’s just changing where the potions are disposed of. It is estimated that the donation is to provide the conditions for the vaccine to reach the citizen’s arm wherever he is.

The validity of vaccines against Covid-19 varies from one immunity to another, according to the package insert:

• AstraZeneca: 6 months
• Pfizer: up to 9 months (bottle closed at a temperature between -90°C and -60°C)
• Coronavac: 12 months
• Jansen: 24 tables

“Vaccines are biological products, not synthetic chemicals. Therefore, they need temperature and storage time. If the vaccine has expired, it may not cause any harm, but it will not be immunogenic enough. [capaz de induzir a resposta imunológica]Explains researcher Jorge Clael Filho, a professor at the University of São Paulo School of Medicine (USP).

According to Kalil, the viability of vaccines is tested from article With animals showing duration, since industrialization, the immune system can stimulate the immune response.

“You leave the vaccine stored in the refrigerator, freezer or at room temperature, depending on the type of vaccine, and you will test the physical and chemical properties and potency of the vaccine, if it continues to elicit a good response,” he explains.

According to the researcher, the short expiration times of vaccines against Covid-19 may be associated with the reduced period of loss of validity analysis. Considering that the immunization agents were developed in record time with the aim of containing adverse effects epidemic.

What could happen is that countries try to use the vaccines they bought. When they see that they are not going to use it, they donate it to the World Health Organization, with a short period of use,” Khalil says.

From production to use

Covid-19 vaccines can be produced using different technologies. The end goal is the same: agitation immune response And protect the body from the development of serious cases, hospitalization and death.

The production process is similar, considering the steps involved in formulating the active pharmaceutical ingredient (IFA), the raw material for the fortifying agent; add installation components; Quality control, packaging and labeling (See step by step the table below).

Import of vaccines in Brazil

In August, Anvisa set new rules with a view to Make importing vaccines more flexible Against Covid-19 and inputs used in the manufacture of immunizing agents. The process simplified import approval guidelines.

With the change, Anvisa’s technical and management team began to comment on the import request within 48 hours after submitting the process. Now, import order analysis can be done before the process is included in the agency system, by sending an email that is done before the shipment arrives in Brazil.

You are vaccine producers They can sign a commitment term that they will provide the required information before using the vaccines.

“A release mode called ‘period of guard and liability’ occurs in cases where the goods are cleared, leaving the airport and going to the importer’s storage center, upon signature by the importer, on the condition of the obligation to submit the outstanding documents before the products are used,” he says. note from Anvis.

Even after the decision, the need to release Vaccine Infusions From the National Institute for Quality Control in Health (INCQS/Fiocruz), in the post-launch phase of Anvisa.

Brazil has already received batches of ready-made vaccines from AstraZeneca / Oxfordand Coronavac/Sinovac, Pfizer/BioNTech, and Janssen.

Epidemiologist Carla Dominguez explains that imported vaccines take longer to reach the population.

“Vaccines that come from abroad must go through customs clearance, through a prescription. Next, the import of the goods must be authorized by Anvisa, which will check if the shipment has arrived as per the standards. After release, it is possible to withdraw the doses from the airport ‘ says Carla.

After the fortifications are released, they are transferred to the logistics distribution center in Ministry of Health, located at Guarulhos Airport, in São Paulo. The place has a dose storage structure in acclimatized areas with different levels of cooling. At this stage, teams from the ministry sort and monitor the quality of the vaccines.

The distribution strategy is determined by the Ministry of Health National Board of Health Trustees (Conass) and the National Council of Municipal Health Trusts (Conasems), which represent states and municipalities, respectively.

The three cases prepare the technical report that collects data such as the amount of doses allocated to the states, The target audience of the campaigns Target first, second, or support doses.

Immunization Leave the distribution centers and reach the states within 48 hoursAccording to the Department of Health, from this point onwards, states and the Federal District are responsible for distribution, which can take place within seven days.

“Brazil has these logistics ready and organized, which means we are able to take vaccines to large centers within 48 hours. We Remote locations, it takes 1 week to 15 days, using boats or helicopters, for example,” says Carla.

According to the expert, the time between release of vaccines by laboratory production and application in the population of countries can vary, reaching up to three months, since not all countries have the capillary structure of the Unified Health System (SUS).

“In some countries, vaccination is mainly carried out in the form of a campaign. There is no Health services As we have it in Brazil. They need to have people in that location to receive, store and apply the vaccines, and the time they spend will depend on each country,” he explains.