Clinical Vaccine Trials in Peru

COVID-19 Reports on Latin America and the Caribbean: No. 18

After seeing the deadly effects of the pandemic, the Government started to find out about the vaccines prepared by different laboratories in order to protect the population against COVID-19. Thus, in August, the Peruvian Government signed an agreement with state owned Chinese lab, Sinopharm, to conduct clinical trials in Peru for two (2) vaccines in Phase III, in aspects of safety (to evaluate if they do not cause adverse events) and efficacy (to evaluate if they protect from infection). These trials have the technical support of two (2) prestigious universities in the medicine field, Universidad Nacional Mayor de San Marcos and Universidad Peruana Cayetano Heredia. Additionally, Johnson & Johnson has started calling for volunteers in Peru for its Phase III trials, as well as in other Latin American countries. Finally, the Government has recently announced that AstraZeneca will also start soon its trials. However, Peru “said it had withdrawn from signing a coronavirus vaccine purchase agreement with AstraZeneca because it did not provide data on its vaccine studies.” Best to our knowledge, the Chinese, Sinopharm, is the only one (1) of the three (3) that will start soon trials on children, which is going to be interesting to follow. 

On the other hand, Peru and other Latin American countries are all confident in Covax, the World Health Organization initiative to “speed up the search for an effective vaccine for all countries. At the same time, it is supporting the building of manufacturing capabilities, and buying supply, ahead of time so that 2 billion doses can be fairly distributed by the end of 2021.”

 Legal Regimen for Trials

The legal framework for these trials is conformed by the Clinical Trials Regulations (Supreme Decree N° 021-2017-SA) and the Guidelines for Conducting Clinical Trials during the COVID-19 Pandemic (Resolution N° 139-2020-J-OPE/INS of the Peruvian National Institute of Health). 

Purchase of Vaccines 

To obtain the vaccines, the Government has adopted three (3) different strategies. It allows clinical trials within its territory, which will allow Peru to have a preferential treatment to buy a high number of vaccines at good price. As stated above, Peru also participates in the Covax initiative. Finally, the Government is conducting direct negotiation with  laboratories. In this respect, to date, the Peruvian Government has assured the signing of confidential agreements with thirteen (13) laboratories. With ten (10) of them, it has signed non-binding agreements. With Pfizer, it has signed a binding agreement for the purchase of 9.9 million doses of its vaccine.

Likewise, to allow the import, distribution, commercialization, and purchase by consumers, the Government has recently sent bill Nº 6273 to Congress to amend article 8 of the Law No. 29459, Law on Pharmaceutical Products, Medical Devices and Healthcare Products. The bill proposes to grant conditional health registration for one (1) year for medicines and biological products, which have successful results at Phase III of their clinical studies in the prevention and treatment of serious life-threatening illnesses. This registration would be renewable, as long as it complies with the respective regulations.  

Meanwhile, a pandemic of questions rages on

The clinical trials come at a time when the amount of positive cases has continuously dropped. In fact, the period of October 19-November 19 calculated about less than 2,000 deaths and less than 75,000 positive cases. Besides, international commercial flights have resumed since October 5. In the meantime, while state of national emergency is active yet (state of national emergency was declared from March 16, 2020 to March 31, and extended first until April 13; next April 26, and so on), and a nightly curfew is still in place; Peru is fearfully expecting a second COVID-19 wave of cases in a two (2) to six (6) month period time, asserted the Health Minister on November 23

This chart shows the number of deaths in Peru, based on their age and sex. Source: La República

Although the pandemic is not over in Peru, it is relevant to ask ourselves why COVID-19 hit so hard the economy and health of Peruvians: is prosecutorial investigation, incarceration and/or ongoing trials for the last six (6) Peruvian Presidents a clear sign that the country is deeply sunk in corruption, so the effects of pandemic were “expected”? Was the declaration of COVID-19 as a global pandemic by the WHO on March 11, 2020, too late to allow a proper response by the Peruvian Government? Weren’t the stimulus packages for the population enough to alleviate the economic crisis? Has the frequent change of Health Ministers during the pandemic affected the definition of a consistent policy in the sector to fight the disease? Hopefully, Peru has learned of its mistakes and will avoid the death of more innocents in the near future.

By Juan Andres Fuentes

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