Divine human comedy
Parodying (or paraphrasing?) the great Belchior, in the beautiful song “Divine Human Comedy”, timeless, we are left philosophize about questions of human existence: “I was more distressed than a goalkeeper when he scored. When the vaccine entered me like a sun in the backyard...”
Vaccines should be considered global public goods. There is a good chance that we will have at least half of the vaccines approved in phase 3 coming from China, being developed by SynopharmBy CanSino and A nephew. Today there are four vaccine candidates from China in phase 3 trials clinicians. If you are against Chinese vaccines, get ready, because the world is experiencing and will experience enormous dependence on China in the coming years.
And for those who say "Made in China, I'm out of this", and who want a future without interference from the “Chinese dictatorship”, try to see where the sneakers, clothes, synthetic or artificial textile fiber fabrics, bedding, duvets, pillows, cushions, bedspreads, ottomans, cell phones, computing and IT articles, computers, printers, computer keyboards, toys, electronic games, bicycles, jewelry, printed circuits, integrated circuits, semiconductors, generators, pumps, compressors, household appliances, coffee makers, fans, electrical wires and cables, motors, electrical transformers, pneumatics, insecticides, herbicides, parts for motor vehicles, exploration and drilling platforms oil and much more. Come fromChina, folks!
The "Made in China”The "Assembled in China”, o “Product of China” or “Made in China“ are everywhere. In fact, the gwinter federal released another 12 pesticides, 10 of which came from China through the Act no. 59, published in the Official Gazette of the Union dated 19/10/2020. Ah, but then someone says: vaccines and medicines don't come from China. There is? China, which suffers from this health xenophobia in Brazil, led by president of the USA, is the second largest exporter of pharmaceuticals to Brazil behind only the USA. Most of the pharmaceuticals that the USA exports to Brazil are prepared with Chinese inputs. And around 70% of the active pharmaceutical ingredients essential for the preparation of generic medicines in Brazil come from China.
We are totally dependent on China in the area of medicines, whether branded or generic. And what's more, the active pharmaceutical ingredient (IFA) necessary to manufacture the Oxford vaccine candidate comes from... China! Oops! Yes, according to Fiocruz, the Ministry of Health has already made R$1,5 billion available for the acquisition of 15 million doses of IFA directly from China to AstraZeneca and then to Brazil in December. And where do you think the adjuvants and other vaccine components such as preservatives come from? And where do you think the inputs to prepare our vaccines, like the one we take for the flu, come from? But it seems that this does not matter for the president.
"We should be rowing together to get out of the pandemic quickly.”
O president Bolsonaro, who, like the pUS resident, Donald Trump, with his conspiracy theories, accuses China of having created the virus and spreading Covid-19 around the world, defined the Corona Vac as "João Doria's Chinese vaccine". He was categorical in stating that o gwinter federal will not buy any Chinese vaccine, even if it is approved by Anvisa. Difficult times in which personal opinion and political and ideological issues are more important than science. We are all in this same storm called Covid-19 and when we should be, as a Nation, rowing together to get out of this pandemic more quickly, we see this petty political game about vaccines, giving strength and feeding the irresponsible and criminal anti-vaccine movement.
Efficacy in phase 3 must be based on technical and independent decisions by Anvisa and not on the origin of the vaccine or political decisions and pressures. The President of the Republic cannot decide whether the vaccine is good or not for the Brazilian population, he does not understand science and the effectiveness of vaccines. The Governor of the State of São Paulo cannot set a start date for vaccination. Science will provide the final answer, not the wish of a populist politician. We need to trust scientific criteria and science. This political fight could lead to the population's distrust in vaccination and a drop in adherence to immunization and we will not be able to achieve collective immunity for Covid-19. To return to our lives, normal or abnormal, safely, we will need vaccines.
How immunization agreements are being made
The ministers of the Federal Court of Auditors (TCU) demanded from the Ministry of Health “complete transparency” with disclosure of all stages, results and detailed information about the agreements involved in relation to all vaccine candidates under development against Covid-19. If the federal government maintain the intention not to include the Corona Vac in the PNI (National Immunization Plan), states will be able to make agreements directly with the government of the State of São Paulo. How the vaccines will be distributed to the population without PNI support, I have no idea. The decision of the President of the Republic is an unprecedented sabotage, as the Butantan Institute produces vaccines for the whole of Brazil and the most important thing is to protect the population from this virus that has already claimed almost 160 thousand Brazilian lives in almost 8 months of pandemic.
After the President of the Republic's speeches and with the aim of ensuring high adherence of Brazilian citizens to vaccines, when approved by Anvisa, some Bills were presented to the Chamber of Deputies. One of the projects establishes the mandatory vaccination against Covid-19, allowing inclusion in the PNI and distribution to the entire Brazilian population. O PL 4987 / 20 advocates that anyone who is not vaccinated against Covid-19 pays for their treatment if they become infected with the new coronavirus.
A vaccine for mass use in the Brazilian population needs to be approved by Anvisa, unless the National Congress approves a law that authorizes purchase without registration in the country, based on the 13.979 Law, approved in February 2020 to combat Covid-19. The Anvisa Servers Association (Univisa) released a note on 21/10/2020, reinforcing the commitment of Anvisa's career employees to maintaining exemption, integrity, ethics and speed in the analysis of all regulatory processes aimed at combating Covid-19, regardless of origin or nationality.
Mass vaccination when?
We are scientists, not populist politicians. We know the arduous and long road to developing medicines and vaccines. Apparently, unfortunately, it is unlikely that we will have mass vaccination in Brazil in 2021. Phase 3 clinical trials must be carried out calmly, ethically, transparently, without rushing and without political pressure. It is difficult to conduct a phase 3 clinical trial in 4-6 months. Anvisa should not enter into political issues and cannot be pressured to approve an immunizer with low efficacy. The lower the effectiveness of the approved vaccine, the greater the population's adherence to vaccination campaigns. We are around 212 million Brazilians.
A vaccine with 50% efficacy and adherence of only 50% of the Brazilian population, or 106 million people, would protect only 53 million Brazilians. If we vaccinate all 212 million Brazilians (hypothetically), with a vaccine with only 50% efficacy, only 106 million would be protected. This vaccine can help, but it is far from ideal. We need a vaccine with at least 70% efficacy, so that, by vaccinating 191 million Brazilians (with excellent adherence from 90% of the population), we can protect 134 million people, which is very good. Still, 78 million Brazilians will not be protected. And the first vaccines may not be the best.
A low-efficacy vaccine could give voice to anti-vaccine movement deniers, increase the spread of fake news and wreak havoc on vaccination coverage in the coming years for the main vaccines on our calendar. We are seeing a lot of movement in thes anti-vaccine movements on social media, including YouTube, as shown by published research on 26/10/2020, highlighting that vaccines contain dangerous ingredients, defending freedom of choice and promoting alternative health services based on natural cures. It is a false narrative, which does a huge disservice to public health.
The vaccine is a right
The Federal Constitution of 1998, the Child and Adolescent Statute of 1990 and the Elderly Statute of 2003 guarantee the right to health and life. To the lbehold, decretions and pThe following ordinances, among others, defend vaccination as a guarantee of health: Law 6.259 (1975), Decree no. 78.231 (1976), Ordinance no. 1986 (2001), Ordinance no. 597 (2004), Law 13.979 (2020). After Vaccine Rebellion in 1904, we never need to force anyone to get vaccinated in Brazil. The Brazilian population has always adhered to mass vaccination campaigns and Brazil is a model for the world.
The ideal scenario would be to think about awareness campaigns for the Brazilian population and make clear the idea that getting vaccinated for free is every citizen's right. The population needs to be informed about the importance and safety of vaccines, to protect themselves from Covid-19, once approved by Anvisa. If we convey the idea that vaccines are a right, that they save lives, that they have helped eradicate lethal or disabling diseases, that they are our best public health strategy along with clean water and treated sewage, which have increased our life expectancy, Let's increase population adherence to vaccination against Covid-19. But in this moment of political polarization, I think it is a very complicated task.
Covid-19 is an infectious disease with the potential to cause death and disability, there is no treatment. Therefore, if there is a safe and effective vaccine, the State must require vaccination to defend the entire population, respecting the collective right to health. A citizen must behave as such and get vaccinated. Public health is more important than an individual's desire, it is a matter of respect, empathy, citizenship. Some people argue that vaccination should not be mandatory, as they claim that we live in a democracy and are against it being mandatory. Voting is mandatory, but it is also a citizen's right, military enlistment is mandatory and if you do not vote or enlist, you will suffer sanctions. The yellow fever vaccine is mandatory and if you don't take it, you cannot travel to some countries.
To receive Bolsa Família, families must present their children's vaccination card. In the case of Covid-19, no one has the freedom to infect third parties and as the health risk is high, in addition to notrFor treatment, when we have a vaccine with proven high levels of safety, immunogenicity and efficacy, I think that in this particular case of pandemic, vaccination should be mandatory, as the individual option cannot harm the collective right to health, bringing consequences for society . I am afraid that this moment of political polarization does not allow for a public awareness campaign.
The president of the Chamber of Deputies, Rodrigo Maia, who had been somewhat absent, stated that the Executive and Legislative branches should find a conciliatory solution to prevent the STF from deciding on mandatory vaccination for Covid-19. The STF has the prerogative to decide on the interpretation of laws in Brazil and, at this time of political fights between the federal government and some state governments, it has taken a leading role in managing the health crisis. They are playing with the lives of 212 million Brazilians.
We don't even have approved vaccines for Covid-19 yet, so when we have vaccines approved in phase 3, we will need to carry out public awareness campaigns to have high adherence in vaccination campaigns. This should be enough without having to force anyone to get vaccinated. However, at this time of political polarization, associated with the anti-vaccine movement, I believe there will be no other option than to make vaccination mandatory. I have doubts whether we can expect awareness campaigns to work at this point.
Oxford vaccine candidate
The young volunteer, aged just 28, who was a doctor and unfortunately died in Brazil, due to complications from Covid-19 during AstraZeneca's phase 3 study, had not received the vaccine candidate, but was in the control group and received the placebo . Look at the harm that Covid-19 causes, a young intensive care doctor, without comorbidities, on the front line of combating the new coronavirus, was infected despite taking all precautions and died, like almost 160 thousand other Brazilians, a victim of Covid-19 . This is the second event with the Oxford vaccine candidate. Imagine if these events had occurred with the Chinese vaccine candidate, which would not have been faked news? The Federal Council of Medicine launched a Memorial in honor of the more than 300 doctors who were victims of Covid-19 in Brazil. We respectfully join in this tribute.
Effectiveness of social isolation and indiscriminate use of antibiotics
A study published on 22/10/2020 in magazine The Lancet, involving 131 countries, including Brazil, shows that the adoption of non-pharmacological measures such as social isolation, physical distancing, prohibition of public gatherings and events, transportation and travel restrictions and school closures were effective in stopping the spread of the Covid-19 pandemic. The study showed that the reopening of schools had the opposite effect, with an increase in virus transmission rates.
Microbial resistance, which kills around 700 people per year, is considered one of the biggest threats to global health, is gaining prominence during the Covid-19 pandemic and could kill millions of people per year. A The issue of resistance of bacteria and fungi to antibiotics has been discussed previously in that space e in that matter.
Antibiotics should only be used after proof of bacterial or fungal infection, but we have seen an irrational use, with antibiotics being distributed in the famous miracle kits that promiseem the cure for Covid-19, using the Brazilian population as a guinea pig. The rampant use of antibiotics with no proven efficacy in treating Covid-19, which has a low rate of reinfection by bacteria, as shown in this text e also this article, could lead to an increase in cases of microbial resistance.
Note: This text does not necessarily reflect the opinion of Unicamp.