In a significant development for Covid-19 treatment in Mexico, the Federal Commission for the Protection against Sanitary Risks (Cofepris) has granted full sanitary registration to Paxlovid, a drug developed by Pfizer. This authorization is intended for adults who do not require supplemental oxygen but are at increased risk of progressing to severe disease.
The decision follows a comprehensive evaluation by the Committee for New Molecules and a specialized review team at Cofepris, which concluded that Paxlovid meets the stringent requirements for quality, safety, and efficacy. This milestone comes after the drug was initially authorized for emergency use in January 2022, a move aimed at adult patients with mild to moderate Covid-19 at risk of complications. The emergency authorization was closely monitored and required a medical prescription to prevent misuse.
Paxlovid has already received approval from several prominent international regulatory bodies, including the United States Food and Drug Administration (FDA), Health Canada, the European Medicines Agency (EMA), the National Health Surveillance Agency of Brazil (Anvisa), and the National Agency of Medicines of Chile (Anamed). This broad international approval highlights the drug’s global recognition as an effective treatment option for Covid-19.
The formulation of Paxlovid includes a combination of nirmatrelvir and ritonavir. Nirmatrelvir plays a crucial role in inhibiting a protein in the SARS-CoV-2 virus, thereby preventing its replication. Ritonavir, on the other hand, slows down the breakdown of the drug in the body, allowing it to remain effective for a longer duration. Together, these components have demonstrated an ability to reduce the rate of hospitalization and mortality from Covid-19 by up to 88%.
The administration of Paxlovid will continue to require a medical prescription. Health professionals are urged to carefully evaluate the use and risk factors detailed in the authorization letter to prevent misuse, self-medication, and irregular sales. This measure aims to ensure that the drug is used safely and effectively, maintaining the integrity of its intended therapeutic benefits.
As Mexico continues to navigate the challenges posed by the Covid-19 pandemic, the full registration of Paxlovid marks a pivotal step in expanding treatment options for vulnerable populations. The authorization by Cofepris not only underscores the country’s commitment to combatting the virus but also aligns with international standards of medical care.
The full registration of Paxlovid is expected to enhance the country’s response to the ongoing COVID crisis, providing healthcare professionals with an additional tool to manage and mitigate the impact of Covid-19. As the situation evolves, authorities continue to emphasize the importance of vaccination, public health measures, and adherence to medical guidance to protect individuals and communities across Mexico.
