RIO DE JANEIRO, BRAZIL – The vaccines against the novel coronavirus are still in their trial phase. The most advanced, in phase 3, the last stage required by regulatory agencies before approval, are in their final stages of administration to volunteers and awaiting preliminary results until the end of the year.
However, despite the absence of their efficacy confirmed – that is, the guarantee that the vaccine is able to prevent Covid-19 – and safety, Russia, China, and the Arab Emirates have already begun administering the immunizer to their populations.
Russia was the first country to approve the registration of a vaccine against Covid-19. In early August, President Vladimir Putin said that the Sputnik V, developed by the Gamaleya Institute in Moscow, was granted regulatory approval in the country. Shortly thereafter, Putin announced that the immunizer would start to be administered to people at high risk of infection and, in September, the first batch of the Sputnik V was released for use in the general population.
In early October, Russia granted regulatory approval to a second vaccine developed in the country, the EpiVacCorona, from the Vector Institute, a Russian center for biological research. As with the Sputnik V, the new vaccine was approved before the start of phase 3 trials.
Recently, Russia announced that it has submitted to the World Health Organization (W.H.O.) an application for expedited registration of the Sputnik V vaccine to be included in the organization’s emergency use list. The WHO’s Pre-qualification Drug Program was developed to ensure that drugs meet acceptable quality, safety, and efficacy standards.
If approved, the Sputnik V will be granted the organization’s endorsement, which may ease its purchase by international and multi-country organizations. “If the vaccine is pre-selected, it can be included in the list of drugs used by countries in their wholesale purchases,” said the Russian state fund, which coordinates the production of the vaccine. According to the W.H.O., there is no deadline for a reaction to the request. To date, no vaccine against Covid-19 has been pre-qualified and there is no list for emergency use.
In China, vaccines from Sinopharm, CanSino Biologics, and Sinovac have been approved for limited use. In an unprecedented move, the Chinese military approved the CanSino immunizer as a “particularly required drug” in June. The decision is effective for one year. It is not known whether immunization is mandatory or optional for soldiers.
In July, the Chinese government granted emergency use approval for the CoronaVac vaccine as part of a program to vaccinate high-risk groups, such as medical teams, according to Reuters. Earlier, it had been reported that only the vaccine developed by Sinopharm’s National Biotechnology Group of China (CNBG) would be used. In September, China reported that the World Health Organization had approved the emergency use of vaccines in the country.
The United Arab Emirates granted emergency approval for the use of the coronavirus vaccine developed by the Chinese state-owned pharmaceutical company Sinopharm in September, six weeks after the start of human trials in the region. “The United Arab Emirates authorizes the emergency use of the vaccine against Covid-19 for frontline members who are at increased risk of contracting Covid-19,” said the United Arab Emirates National Crisis and Disaster Management Authority on Twitter.
The decision was prompted by the increased number of cases in the region and made Sinopharm the first vaccine manufacturer to receive approval from a foreign country.
Venezuela is the most recent country to announce the start of vaccination against Covid-19 late this year. During a live stream on state television, President Nicolás Maduro said he plans to vaccinate citizens with the Russian and Chinese vaccines as of December or January. The date will be contingent on the arrival of the products in the country. Senior citizens and people with pre-existing conditions will be prioritized, but Maduro said that all Venezuelans will be vaccinated, according to Reuters.
Safety is priority
The recent surge of Covid-19 cases in Europe has raised the possibility for countries in the region to follow the above examples and expedite approval for emergency use of a vaccine against the disease. However, the European Medicines Agency (EMA) has said that while providing a rapid response to Covid-19 is the agency’s top priority, approval of a vaccine will only be possible with “strong evidence of its safety, efficacy, and quality”.
“Authorization will be granted when there is evidence that the vaccine’s benefits outweigh any risks. In general terms, large-scale efficacy trials involving thousands of subjects would be required to support authorization to market a vaccine against Covid-19. These trials should be designed to assess the vaccine’s efficacy in protecting against Covid-19 and its safety,” said the organization.
Along the same lines, in early October the FDA, the U.S. agency that regulates drugs and health products, toughened its guidelines for approving the emergency use of vaccines against Covid-19 in the country. The new rules require at least half of the study volunteers to be monitored for at least two months after the administration of the vaccine’s second dose (in vaccines operating under this scheme). The FDA also expects vaccine manufacturers to document five cases of severe infection in people who were administered a placebo instead of the vaccine.
Source: Veja