On Sunday, 17/01/2021, Anvisa approved the first vaccines for emergency use against Covid-19 in Brazil. Without a doubt, a historic day for this country, which begins a new stage in the real fight against the Covid-19 pandemic.
Emergency use is a temporary concession so that the country can use a batch of 6 million doses of Coronavac, produced by the Chinese company Sinovac in partnership with our Butantan Institute, and a batch of 2 million doses of the Oxford/AstraZeneca vaccine , from the Serum Institute of India, the largest vaccine manufacturer on the planet by number of doses.
The emergency use of vaccines in Brazil is urgent due to the severity of the pandemic and the increase in the number of cases in Brazil. As we are observing, the virus is spreading rapidly across the country, is mutating and may be becoming more transmissible, which could lead to a considerable increase in the number of infected people, hospitalizations and, unfortunately, deaths. As human behavior doesn't help much either, we are still far from seeing a way out, but it's a start. The definitive record takes more time, requires more data, analysis, and a more complete study.
What is happening in Manaus reflects the mistaken decision not to respect non-pharmacological measures such as the importance of wearing masks, physical distancing and social isolation. There they did not lock down, they continued living their lives normally, hoping to reach a high number of infected people and the much-vaunted collective, herd immunity, which unfortunately does not protect us from Covid-19. There was no shortage of warnings about the risk and today there is a lack of oxygen even for premature babies. Scientific denialism exacts a heavy price, but we are all rooting for our Brazilian brothers in Manaus.
How vaccines for emergency use are evaluated
To request emergency use, some characteristics must be met:
- There must be phase 3 clinical studies underway in Brazil;
- Approved doses can only be used in pre-defined target audiences and during a pre-determined period, justified by the pandemic;
- In this case, the target groups were defined as healthcare professionals on the front line in the fight against Covid-19, volunteers who participated in phase 3 in the CoronaVac placebo group, vulnerable populations, elderly people over 75 years old, indigenous people and quilombolas;
- The approved doses can only be administered by the National Immunization Program (PNI), distributed by our weakened, but very valuable Unified Health System (SUS), being the responsibility of the Brazilian State;
- The concession for emergency use will only be for the duration of the pandemic and can be revoked;
- The application of doses is considered experimental in nature, people accept to be vaccinated voluntarily, without being obliged and without any sanction if they do not want to be vaccinated, as in this case, the vaccine approved for emergency use is a product considered still under development , so you need a free and informed consent form;
- Emergency use is not definitive health registration, so the doses cannot be sold in the private network, they must only be used in the PNI/SUS.
And after emergency authorization
Both the Butantan Institute and Fiocruz must continuously send to Anvisa all new information on safety, efficacy, quality, as the vaccines are subject too continuous risk/benefit assessment process.
People who take the vaccines will undergo continuous monitoring to assess any adverse events. Security surveillance is required.
Emergency use was granted for the 6 million doses of the Coronavac vaccine, which are already on Brazilian soil and which will be used to immunize 3 million Brazilians, as each will be necessarytwo doses. Emergency use was also granted for oTwo million doses of the Oxford vaccine, coming from the Serum Institute of India, will be used to vaccinate 1 million people. However, these doses of Indian Serum still do not have a defined date of arrival in the country.
All new doses of vaccines produced here in Brazil by Butantan or Fiocruz or from another source must undergo new requests for emergency use until definitive registration.
This is the logic of having faster licensing, but without compromising on safety, quality and effectiveness.
CoronaVac has already been applied in emergency use in China, Indonesia and Turkey, while the Oxford vaccine, produced by the Serum Institute of India, has been used in an emergency manner in India and Bangladesh.
Vaccine developers will be able to request definitive registration after submitting all complete documentation proving the quality, efficacy and safety of the vaccines, including all data from studies in all phases, 1, 2 and 3. After definitive registration , then yes, the vaccines can be used for mass vaccination, being distributed in the public and private network. It's a longer process.
State of São Paulo brought Coronavac
The government of the state of São Paulo and the Butantan Institute brought the Coronavac vaccine to Brazil. Now, we all hope that the federal government will immediately start the national immunization plan, as the Coronavac vaccine is from Brazil and is the only vaccine on Brazilian soil today.
A black nurse from São Paulo, Monica Calazans, 54 years old, was the first Brazilian to be vaccinated, on 17/01/2021, at the Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo (USP). She works in the ICU of the Emílio Ribas Institute of Infectious Diseases. The second Brazilian to be vaccinated was nurse Wilson Paes de Pádua, aged 57, at the Vila Penteado hospital, in the North Zone of São Paulo.
The third person to be vaccinated was geriatrician Fabiana Fonseca, from the emergency room at Padre Bento hospital, in Guarulhos. On the same day we also had the first indigenous person vaccinated in Brazil, Vanusa Kaimbé, 50 years old, nursing technician and social worker, who lives in the "Kaimbé children of the earth village", in Guarulhos. And who wasn't moved and didn't cry when they saw these scenes?
17/01/2021 really brought us unique moments, with hope, light, a real possibility of starting to emerge from this pandemic and saving lives. Every life is equally precious and all lives matter.
Congratulations to Butantan and the government of São Paulo. Long live science, long live vaccines against Covid-19.
Vaccines save lives
Our enemy is the virus, not vaccines, vaccines are friends of life, they save lives. And the time to celebrate and congratulate Butantan, Fiocruz, Anvisa, everyone involved in the arrival of this vaccine and all professionals from all areas who are fighting to defend the country in the war against the virus. Now we need vaccines in sufficient doses for everyone, distributed free of charge, in an equitable and egalitarian manner.
Vaccination is just beginning and we are sure that the images of people being vaccinated will infect those who are hesitant and even those who are against vaccines. Let's spread empathy, smiles and hope. And we will soon be able to observe the side effects of mass vaccination, as we we will hug our parents, grandparents, children, friends again, children will go back to schools, universities will open, we will have a recovery in the economy, everyone will go back to work without fear, we will have audiences in football stadiums, gymnasiums, sports courts , we will be able to move around, travel, gather, have meetings, go to bars and restaurants, parties and beaches, without guilt.
At this moment, we need to ask ourselves as a society, what world we want to live in, because what we choose as a collective, as a nation, in the coming months, will dictate what the future of this country will be like.
Embrace the cause of mass vaccination and may millions of doses of vaccines come. This little arm here is just waiting for its turn in line to get a vaccine and science in its veins.
Vaccine effectiveness
The narrative surrounding the effectiveness of vaccines is now becoming less relevant. With the start of vaccination, when we have vaccines for everyone, regardless of the effectiveness of the vaccines, as long as we have mass adherence among the Brazilian population, we will begin to stop the spread of the virus and the spread of the disease. But we need millions of doses of all vaccines approved by Anvisa, concrete actions to raise awareness and enlighten the population and high vaccination coverage. We need a strong sense of social responsibility on the part of the population, empathy, respect for life, no more denial of science.
A good vaccine is the one that is approved by Anvisa and arrives in your arm first. It is no longer possible to ideologize vaccines against Covid-19. And even with the start of the vaccination campaign, it is essential to highlight the importance of non-pharmacological measures to combat Covid-19, such as the use of masks, physical distancing, social isolation and hygiene habits.
Anvisa monitoring plan
Anvisa has set up a monitoring plan to manage risks and adverse effects of both medicines that have been used for early treatment and vaccines approved for emergency use to combat Covid-19. The information will be entered into the VigiMed system, which will be connected with the e-SUS system notifies. Post-vaccination, in what we know as the pharmacovigilance phase, vaccine development companies and collaborating research institutes must use the VigiMed system to report possible adverse events and any occurrences.
Anvisa and early kit
Anvisa acted as we all expected, in an impartial, democratic, republican way, as a State agency and not a government agency, respecting its commitment to the public health of the Brazilian population. I think you carried out an excellent technical-scientific analysis, although I question the lack of technical visits to the Serum Institute factory in India to verify the conditions of good manufacturing practices specifically at the production plant for this vaccine, despite the agency state that you visited it at the beginning of 2020.
Anvisa also made it very clear during the speeches of the Agency's technicians and directors, that as there are no alternative therapies to combat the spread of the virus, there is no efficient early treatment with medicines to combat Covid-19, emergency use to alleviate the The impact of the pandemic is justified, as we are in a scenario that has already claimed the lives of more than 210 thousand Brazilians. Unfortunately, we know that these early treatment drug kits have only been used in Brazil, as a political narrative. The number of people cured is high, fortunately, but this is the case all over the world. We have been talking since March 2020 about chloroquine, ivermectin and azithromycin, but science has failed to demonstrate any type of benefit, unfortunately.
Anyone who talks about the number of cured people should keep in mind that the number of cured people is high across the planet and is due to people's own immune systems fighting the virus and to our valued health professionals who courageously fight against the virus, in addition to of all the knowledge acquired by science and adopted by intensivists, healthcare professionals and doctors on the front line.
The number of cured people in Brazil today is around 7 million and 410 thousand people, with around 210 thousand deaths, but the number of cured people should include around 70-80% of these Brazilians who died, who were abandoned, so the number of cured people should be greater than the current 7 million and 410 thousand. But denialism and lack of empathy killed more people than expected.
In its position, Anvisa made the message clear, highlighting that as we do not have medication alternatives to control the disease in the early phase, with the aim of alleviating the damage of the pandemic, we need vaccines and the benefits of vaccines approved in phase 3 are very greater than the possible risks.
The virus causes a series of adverse effects on the lungs, heart, neurons, and we still don't even know if it can cause problems in pregnancies. Remember what the Zika virus causes, but science still does not know possible more serious adverse effects of Sars-Cov-2 on pregnancies.
Pharmacovigilance
Do we have uncertainties regarding vaccines? Of course, we have a lot of honest questions! Covid-19 has been with us for just over a year and vaccines were developed to minimize the impact of the disease, but they may not yet prevent infection, they are not sterilizing, but just the fact that infected people may have milder conditions. , with a strong tendency to reduce hospital admissions and deaths, is already a great victory. But we have some certainties too. The Sars-Cov-1 virus killed more than 2 million people on the planet and around 2 thousand people in Brazil and leaves terrible consequences in the most serious cases.
Combating the anti-vaccine movement
This is not the time to relax, to let your guard down epwe need to be even more attentive and vigilant in order to combat the scientific denialism and the anti-vaccine movement created by dark forces. This criminal and irresponsible movement will create narratives, the fake news of the future, linking deaths from natural causes or accidents, with those who took vaccines against Covid-19, saying that people died because they took a certain vaccine. But to turn this game around, we need to ensure that scientific facts and health guidance, based on scientific evidence, circulate widely in order to combat the spread of lies and fake news about vaccines. We need to show, with great transparency and honesty to the Brazilian population, the danger of fueling campaigns of disinformation, conspiracy, denialism.
Observation : This text does not necessarily reflect the opinion of Unicamp.
