Saturday, September 30, 2023

FDA approves updated version of vaccines against covid-19

The Covid-19 vaccines have updated versions to protect against most of the currently circulating variants. This September 11, the United States Food and Drug Administration (FDA) approved the products of the pharmaceutical companies Pfizer and Moderna for use in adolescents and adults and gave permission for emergency use for children between in six months and 12 years.

These vaccines are monovalent, that is, they have only one variant: the XBB.1.5 subvariant of the omicron variant, one of the most widely distributed to date (in the United States and other countries, including Costa Rica).

“Vaccination remains critical for public health and protection against the consequences of Covid-19, including hospitalization and death,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a press release.

According to the scientist, the population can be sure that these updated vaccines meet the FDA’s strict safety, effectiveness and manufacturing standards.

“We encourage people to get vaccinated,” he added.

These drugs still need to go through the approval of the United States Center for Disease Control (CDC), which will provide its recommendations for use and approval of the application at the public health level. The CDC is expected to meet on Tuesday, September 12 to give the endorsement.

Unlike previous vaccination campaigns, it will not be offered for free by the federal health system, it is the insurers that cover the Americans who will make them available as part of the insurance coverage. Those without insurance can benefit from charitable campaigns.

Updated vaccines

The vaccines Comirnaty, from Pfizer, and Spikevax, from Moderna, use the same technology used in Costa Rica: messenger RNA or mRNA. Through this technology, a part of the spike protein (spike or S, in English) of this subvariant is injected into the person and the instructions are given to the immune system to produce the antibodies needed to recognize the virus and deal with it. it is if needed. he was wounded.

The only difference with the previous ones is that, instead of having the version of the virus used before, it has been updated with a more dominant subvariant to date.

Like previous vaccines, their purpose is not to prevent the disease, but its complications, hospitalization and death.

As observed in the FDA review, protection remains against new omicron subvariants that have entered circulation, such as EG.5 (already in Costa Rica) and BA.2.86.

To make this decision, the FDA reviewed the documentation sent by the two pharmaceutical companies based on small clinical trials that updated their products.

Adverse events are very similar to those reported with previous versions of these vaccines.

Regulators are also studying the possibility of approving the vaccine from the company Novavax, which uses another type of technology, where the virus protein is directly injected. This technology is used in other vaccines, such as the one against the human papillomavirus or the new ones against the respiratory syncytial virus.

Who are these doses for?

With these new vaccines, the FDA’s recommendation is to change the panorama for inoculation against covid-19.

Individuals five years or older. They will receive a dose of this new version two months after their last dose. If they have not received doses before, these new versions will be used from the beginning. Those over 12 who have not been inoculated before receive one initial dose, while minors receive two.

Immunocompromised people may need more than one dose, this should be discussed with the doctor.

Individuals six months to four years of age who have been vaccinated. They will receive a dose or two of updating. The number of doses and their interval will depend on the date of the last injection.

Individuals six months to four years of age who have not been vaccinated. They will receive three doses of the Pfizer vaccine or two of the Moderna vaccine.

In Costa Rica

This regulation applies only to the United States. The European Medicines Agency (EMA) approved Pfizer’s drug on September 1.

Registering a vaccine in Costa Rica takes time. The first step consists of presenting the pharmaceutical company to the Ministry of Health in its dossier (file) with product information and clinical trials.

Once the dossier is submitted, the health authorities will analyze it, ask for clarifications and call meetings if necessary.

So far this has not been done, neither of the two companies have requested it.

When everything is clear, the National Commission for Vaccination and Epidemiology (CNVE) determines whether it provides the endorsement and specifications for use. This guarantees its entry into the country, but does not mean that the drug is used in social security; To do this, the Costa Rican Social Security Fund (CCSS) must conduct a cost-effectiveness analysis.

Nation World News Desk
Nation World News Desk
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