Prof. Luiz Carlos Dias | Photo: Antonio Scarpinetti

Luiz Carlos Dias He is a Full Professor at the Institute of Chemistry at Unicamp, a full member of the Brazilian Academy of Sciences (ABC), Commander of the National Order of Scientific Merit and member of the UNICAMP Task Force in the fight against Covid-19.

Anvisa approves Pfizer vaccine for children aged 5 to 11

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This is wonderful news for this year-end. As a Brazilian citizen, scientist and father, I am very happy with Anvisa's decision to approve on 16/12/2021, the application of the Pfizer/BioNTech vaccine for children in the age group 5 to 11 years. The technical area of ​​Anvisa, experts from the Brazilian Societies of Infectious Diseases (SBI), Immunology (SBI), Pediatrics (SBP) and Pneumonia and Phthisiology (SBPT) participated in this decision. The announcement of the technical assessment by Anvisa may be checked by YouTube

The dose was developed especially for children, it has the same active ingredient, but is 1/3 smaller, com 10 micrograms (mRNA concentration is 0,1 mg/mL). dose for people aged 12 and over is 30 micrograms (mRNA concentration is 0,5 mg/mL). The vaccine will be administered in a two-dose schedule every 21 days. With this dosage and based on scientific evidence, the vaccine showed an excellent safety and efficacy profile, high reactogenicity and high antibody production. This pediatric version comes in a vial with an orange cap to distinguish it from the purple caps used on patients aged 12 and over, avoiding confusion and errors when administering the vaccine. Vials for children contain a larger number of doses (10 doses for children aged 5 to 11 years and six doses for people aged 12 and over). The vaccine can be stored for longer at a temperature of 2 to 8 degrees Celsius (about 10 weeks after thawing). Children aged 5 to 11 years will be included in the Pfizer vaccine leaflet, which already has definitive registration in Brazil.

Data from 15/12/2021 shows that 160.374.514 million people (75,18% of the Brazilian population) took the first dose and 140.781.302 million people (66% of the population) took the second dose + single dose of the Janssen vaccine since 17/01/2021. The booster dose was applied to 21.694.778 million people (10,17% of the population), numbers that go increase until the end of December 2021.

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Vaccination of approximately 22 million children in this age group (according to IBGE estimates, but numbers differ between sources) will allow Brazil to achieve complete vaccination coverage close to 90% or exceed this by Carnival 2022.

We will defeat the virus and its denialist allies who cry out against vaccines. They They will complain fiercely on social media against the approval of vaccination for children, but fortunately, many of them are going to get vaccinated in secret.

In the worrying scenario, with the emergence of Ômicrom and the arrival of the end of year festivities, it would be wonderful to have our children in this age group vaccinated with the first dose immediately. But, unfortunately, we will have to wait until January, as we do not have doses of this pediatric vaccine in the country. It is urgent that o Ministry of Health acquires pediatric doses. Once again, we are victims of the lack of planning on the part of those who should be looking after the health of our population.

In November, the EMA (European Medicines Agency) approved the use of the Pfizer-BioNTech vaccine for children aged 5 a 11 years. Shortly afterwards, on 15/12/2021, several European countries started vaccination. This measure is absolutely necessary to help combat the spread of Ômicrom and keep schools open there.

Let's hope that the CoronaVac vaccine is also approved for children and adolescents aged 3 to 17 years here in Brazil. CoronaVac is a great vaccine for this age group. Anvisa received on 15/12/2021, the request from the Butantan Institute of CoronaVac indication for children and adolescents and you have until 15/01/2022 to express your opinion. CoronaVac has been used on an emergency basis in Brazil for people aged 18 or over since 17/01/2021.

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Ômicrom variant advances quickly

The Ômicrom variant spreads quickly, has already been found in 77 countries and should be circulating in practically all countries and territories, according to WHO. In Europe, the variant is doubling the number of cases every threeyou days, which suggests it will be the predominant new variant by mid-January. In Brazil, fortunately, with the good acceptance of vaccines by the population, we can hope and hope that the number of hospitalizations is not high. 

But we are not going to stop Ômicrom’s progress with vaccines alone. It is fundamental follow adopting non-pharmacological measures such as the use of masks, physical distancing and hand hygiene habits, avoiding crowds, especially in closed and poorly ventilated places, in addition to adopting testing and genetic sequencing procedures to monitor the emergence of new variants .

Still preliminary data shows that Ômicrom is more transmissible than the Delta variant, but causes less serious clinical conditions. Even so, The rapid advancement is worrying and, therefore, we cannot jump to conclusions, as we still do not know the effect of the new variant on older populations and those who are immunosuppressed. A Ômicrom infects convalescent people, recovered from infections with other variants and also infects vaccinated people, as we had not previously observed for the other variants of concern. AND in urgent need vaccinate everyone as quickly as possible, including the most vulnerable populations in low-income countries. The WHO has constantly warned about low vaccination rates in low-income countries. The expectation is that only in the second half of 2024, countries on the African continent will have around 70% of their populations vaccinated. Can't wait that long...

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TAnyone who is eligible to take booster doses should do so immediately. A dose of any of the Covid-19 vaccines, whether the first dose, the second or the booster dose, is our best Christmas gift in 2021. Each additional dose of any of the Covid-19 vaccines stimulates the our immune system and triggers a process of evolution of neutralizing antibodies (and non-neutralizing antibodies), producing antibodies that bind more strongly to the virus's S protein, through a process known as affinity maturation, in addition to the production of a cellular protective response through of cytotoxic cells.

OAnother good news is that researchers from the Institute of Biomedical Sciences of the University of São Paulo (ICB-USP) isolated the Ômicron variant strain of Sars-CoV-2, which will allow other laboratories in the country to detect the spread of Ômicron and evaluate the effectiveness of the vaccines in use against the new strain. Read more here (https://agencia.fapesp.br/pesquisadores-da-usp-isolam-variante-omicron-do-sars-cov-2/37552/).

In time, Fiocruz launched a primer for end of year festivities, with science-based guidance. Read more about the subject

Pfizer and BioNTech announced that two doses of their messenger RNA vaccine lose some of their effectiveness, as they produce fewer neutralizing antibodies against Ômicron, but that a third dose recovers the neutralizing capacity and considerably increases the production of antibodies, after tests carried out in the laboratory. But we know that the cytotoxic cell response is also very important. A study released in South Africa suggests that after two doses, the effectiveness of the Pfizer-BioNTech vaccine dropped to 33% to prevent infection against the Ômicron variant, but showed 70% effectiveness against hospitalizations and more serious cases. A similar drop was seen for the AstraZeneca vaccine. For both the Pfizer and AstraZeneca vaccines, the effectiveness for protecting against symptomatic infections was around 70%. High rates of efficacy and protection against Ômicron are achieved with a third dose or booster dose.

Due to vaccination against Covid-19, epidemiological indicators in Brazil are good. O Bulletin disclosed by Fiocruz's VigiVac project shows that all vaccines against covid-19 used in Brazil (CoronaVac, AstraZeneca, Janssen and Pfizer) are highly effective and provide a large reduction in the risk of infection, hospitalizations and deaths from Covid-19. More information. This is science saving lives.

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STF approves the vaccination passport

Although there are still some unknowns, there is another good news for those who defend life, science and vaccines: the Federal Superior Court (STF) responded to an injunction from Minister Luís Roberto Barroso and determined that a vaccine passport is mandatory for travelers coming from abroad to Brazil. Only they They will be able to enter the country with proof of vaccination with any of the vaccines approved by Anvisa. According to the STF, travelers arriving in Brazil may be exempt from presenting proof of vaccination only for medical reasons, humanitarian reasons or if the country of origin does not have vaccines against Covid-19. This dismissal for medical reasons worries me, considering the amount of denialist and anti-vaccine doctors that can issue false certificates. Follow what's happening in France.

The STF established that for Brazilians and foreigners who reside in Brazil and travel abroad after 14/12/2021 and who do not present proof of vaccination upon returning, they must ter negative covid-19 test and quarantine for five days. Anyone who traveled before 14/12/2021 must present a negative Covid-19 test upon returning to Brazil.

It's a decision a be celebrated. It's not because of reciprocity, just because other countries require vaccination and other health measures to cross their borders. Brazil cannot become a destination for the unvaccinated, so that denialists and anti-vaccines come here for tourism. AND that's why andsimply requiring a negative test or five-day quarantine is not enough. It is crucial get tested and be vaccinated. This decision respects Anvisa's recommendation and the more than 617 thousand people who lost their lives to Covid-19 in Brazil. Respecting freedom means respecting the collective, so that as a Nation, we can emerge from the pandemic. Nobody has the right to go around infecting other people, just because they defend a political flag and don't want to get vaccinated.

We cannot accept that Brazil allows the entry of unvaccinated people from other countries. We fight internally against an anti-vaccine movement criminal, against scientific denialism, against pseudoscientists, against doctors who do not follow science, against some pseudojournalists and former athletes, politicians and religious leaders, against defenders of the covid kit hoax for early treatment, against defenders of ozone therapy and others false therapies against covid-19. For the safety of our population, it is essential to require a vaccination passport and test anyone entering the country, to avoid the creation of internal transmission chains. The STF made the correct decision to protect our population, demanding mandatory vaccination. This is a measure that aims to defend health positions and policies based on science to protect Brazilian citizens.

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Paxlovid, Pfizer's pill against Covid-19

American pharmaceutical company Pfizer announced clinical studies with 2.246 adults, who confirmed that the clinical candidate for oral use, the antiviral called Paxlovid™ (PF-07321332; ritonavir), reduces the risk of hospitalization or death in high-risk adults infected with Covid-89 by 19%, in compared to the placebo group and is effective even against the new Ômicron variant. Paxlovid™ contains two substances: ritonavir and nirmatrelvir. Nirmatrelvir works by blocking the 3CL protease enzyme of Sars-CoV-2, inhibiting the replication of the virus in our cells, while ritonavir is used to reduce the speed of nirmatrelvir metabolism. Administration would involve a dose of 300 mg of nirmatrelvir and 100 mg of ritonavir, twice a day for a period of five days.

The data was shared with the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). This could prove to be an additional alternative in the fight against the virus, but in no way will the medicine replace vaccines, as it will only be used in people already infected by the virus.

To end 2021...

With the start of the application of vaccines against covid-19, the year 2021 brought hope to Brazil. But we will need to keep fighting. The charlatans will remain firm and united, creating fake news killers saying that vaccines are causing serious adverse effects and killing people.

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With the start of vaccination for our children aged 5 to 11, we need to prepare ourselves for another criminal wave of misinformation and murderous lies that supporters of the anti-vaccine movement will create, spreading fear among mothers and fathers, through fake news about deaths and adverse effects in children, without a causal relationship with vaccines. By defending an anti-vaccine political banner, criticizing non-pharmacological measures, they are the best allies the virus could find. However, they have no proposal to get us out of this serious health crisis. They are cruel, espousing fear and hatred. But Brazilian society has an army of good, to defend vaccines and life. Let's get vaccinated! CEvery vaccinated person brings us closer to the end of the pandemic.

Observation: The articles published do not reflect the opinion of Jornal da Unicamp. Its publication aims to stimulate the debate of ideas in the scientific, cultural and social spheres.

Watch the video: Why we need to vaccinate our children. Deaths in the age group 0 to 19 years due to covid19

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