Nov 16, 2021

Moderna Spikevax COVID-19 Vaccine

November 16, 2021 0 Comments

 All COVID-19 vaccines authorized in Canada are safe, effective, and of high quality.


Name: Spikevax® Vaccine from Moderna against COVID-19

Manufacturer ModernaTX, Inc.

Type: mRNA

Status: Approved by Health Canada

Approved for: people 12 years of age and older

Method of administration: Injection into a muscle (usually the upper arm)

Number of doses: 2 doses

Moderna Spikevax COVID-19 Vaccine



People for whom the vaccine is approved

The vaccine is approved for people 12 years of age and older. Its safety and efficacy in young people under 12 years of age have not yet been demonstrated.


Efficiency

Clinical trials showed that from two weeks after the second dose, Moderna's Spikevax® COVID-19 vaccine was 94.1% effective in protecting clinical trial participants from COVID-19.


Dosage

Two doses are required for maximum protection.


The dosage schedule approved by Health Canada calls for 2 doses at one-month intervals, based on evidence from clinical trials.


A booster dose of the Moderna COVID-19 Spikevax® vaccine may be given to people 18 years of age and older at least six months after completing their primary vaccine series.


Your province or territory decides when doses are administered.


These decisions are based on public health recommendations and the most recent data.


Mixed dose schedules

A different vaccine may be offered for your second dose. For example, you may have received the Comirnaty® vaccine from Pfizer-BioNTech as the first dose and you may have been offered the Spikevax® vaccine from Moderna as the second dose. This is called a series of mixed vaccines.


The National Advisory Committee on Immunization (NACI) recommends getting an mRNA vaccine (Comirnaty® from Pfizer-BioNTech or Spikevax® from Moderna) for your second dose. Find out more about mRNA vaccines


For more information:


  1. mRNA vaccines
  2. Viral vector vaccines

Vaccine ingredients

Medicinal ingredient

MRNA

Other ingredients

  1. 1,2-distearoyl-Sn-glycerol-3-phosphocholine
  2. Acetic acid
  3. Cholesterol
  4. Lipid SM-102
  5. Polyethylene glycol (PEG) 2000 DMG
  6. Sodium acetate
  7. Sucrose
  8. Tromethomin
  9. Tromethomin hydrochloride
  10. Water for injection
This vaccine does not contain common food allergens, such as eggs, shellfish, gluten, or nuts.



Possible side effects

After administration of a vaccine, it is common to have temporary side effects. They usually last a few hours or days after vaccination.

This is the body's natural response to build immunity against disease.

Common side effects of vaccines

    Symptoms at the injection site

  1. Redness
  2. Pain
  3. Swelling

Flu-like symptoms

  1. Chills
  2. Fatigue
  3. Joint pain
  4. Headache
  5. Mild fever
  6. Muscle pain

Rare side effects related to vaccination

Here are some rare reactions that have been reported and confirmed after administration of mRNA vaccine:

  1. Myocarditis and pericarditis
  2. Bell's palsy (facial paralysis)
A severe allergic reaction (anaphylaxis) is also possible, but rare. Signs and symptoms of an anaphylactic reaction to a vaccine include:

  1. hives (bumps on the skin that often cause a lot of itching)
  2. swelling of the lips, face, tongue, or respiratory tract
  3. difficulty breathing
  4. an increase in heart rate
  5. loss of consciousness
  6. a sudden drop in blood pressure
  7. abdominal pain, vomiting, and diarrhea
Call emergency services if you have or are witnessing severe symptoms that could be an allergic reaction after vaccination.


Reporting a possible serious reaction

Consult your health care provider if you experience:

  1. a side effect after receiving a COVID-19 vaccine
  2. any persistent, new, or worsening symptoms
Health care providers should report possible post-vaccination reactions to local public health authorities. They will then report them to the Public Health Agency of Canada.



Summary of this week's report updated November 15, 2021

As of November 5, 2021, 58,739,700 doses of vaccine have been administered in Canada. Adverse events (side effects) were reported by 23,676 people or approximately 4 adverse events reported for every 10,000 people vaccinated.
Of the 23,676 individual reports, 17,777 are considered non-serious (0.030% of all doses administered) and 5,899 are considered serious (0.010% of all doses administered).
Most adverse events are mild and include pain at the injection site or a slight fever.
Serious adverse events are rare but possible. Of these events, anaphylaxis (a severe allergic reaction) was reported 588 times for all COVID-19 vaccines in Canada. This is the reason why you need to wait some time after receiving the vaccine in order to receive treatment in the case of an allergic reaction.
  1. All serious side effects are subject to a medical review to determine if there are any safety concerns that require additional measures. As part of these processes, provincial and territorial partners, the regulator, research networks and medical advisors meet regularly to review the data and verify that there are no safety issues requiring action. Unforeseen security issues are detected early and action is taken immediately.
  2. The Public Health Agency of Canada (PHAC) and Health Canada continue to closely monitor Canadian and international reports from:
  • Thrombosis with thrombocytopenia following immunization with COVID-19 with an AstraZeneca/COVISHIELD Vaxzevria vaccine. Health Canada has updated the product monograph to include information on these very rare events of blood clots associated with low platelet counts following vaccination.
  • Guillain-Barré syndrome (GBS) following administration of AstraZeneca/COVISHIELD's Vaxzevria COVID-19 vaccine. Data in Canada have observed a higher rate than expected in the general population. Health Canada has updated the AstraZeneca/COVISHIELD Vaxzevria Vaccine Product Monograph to include information on GBS.
  • Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the envelope of the heart) following vaccination with messenger RNA vaccines. Data in Canada now indicates a higher number of reports among youth (under 40 years of age) than would normally be expected in this age group in the general population. Health Canada recently updated the product monographs for Moderna's Spikevax and Pfizer-BioNTech's Comirnaty vaccines to include information on these vaccines. 
  • Capillary leak syndrome following vaccination with AstraZeneca/COVISHIELD Vaxzevria vaccine. Health Canada works closely with manufacturers and international regulators to review information as it becomes available and will ensure that manufacturers include the necessary information on product labels as needed. Health Canada has updated the product monograph to include information on capillary leak syndrome, including a contraindication for patients who have previously suffered from this syndrome.
  • Facial paralysis (Bell's palsy) following VACCINATION against COVID-19. Health Canada has updated the product monograph for Pfizer-BioNTech's Comirnaty vaccine and Moderna's Spikevax vaccine to include information on Facial palsy/Bell's palsy.
The benefits of vaccines authorized for use in Canada continue to outweigh the risks.


Nov 15, 2021

Christmas recipe :Scallops gratinated

November 15, 2021 0 Comments

Here is an entry that puts everyone in agreement: the scallops gratinées. Who doesn't literally melt in front of these seared scallops and return in butter, this sauce with fresh cream, white wine, shallots, lemon ...? Who has never tracked down the slightest remnant of sauce in his shell, armed with a piece of bread...? No, definitely, this starter is anything but a walnut starter! 

Christmas recipe Scallops gratinated


INGREDIENTS: 4 PERS.

16 scallops

20 cl of white wine

1 carrot

1 lemon

1 shallot

a few sprigs of chives (according to your tastes)

4 tbsp thick cream

100 g grated Gruyère

15 g butter

4 tbsp flour

Salt, pepper

4 empty shells (ceramic or other) for service




PREPARATION:

Preparation  25 min       Cooking   20 min


  1. Before starting the recipe for scallops gratinées, preheat your oven to 180°C.
  2. Sprinkle the scallops with flour. Heat the butter in a pan, add the nuts and color them for 1 to 2 minutes on each side. When cooking is finished and they are well browned, take them out of the heat and reserve them on a paper towel.
  3. Then proceed to the realization of the sauce. Peel and thinly slice the shallot and sweat it in a pan, without adding fat. Once your shallot is slightly colored, add the white wine, the crème Fraiche and the chives that you will have finely chiseled. Then add the lemon juice and let the sauce sit.
  4. Meanwhile, peel and then slice the carrot into very small dice. Cook them in slightly salted boiling water.
  5. Now move on to the training of scallops. In a ceramic shell (or other), lay 4 nuts and small diced carrots. Season with salt and pepper at your convenience and cover with sauce. Finally, add a small pinch of grated Gruyère.
  6. Bake the shells in the oven at 200 ° C for about 8 minutes and serve them hot, well gratinated, with a salad in which you can add some citrus fruits.

TRICKS

We give you a small variant, just like that, it's a gift: replace the carrot with a minced leek white... The marriage of scallops and leek works wonderfully! A good listener... ;)

Nov 13, 2021

Christmas recipe :Foie gras terrine with hazelnuts, pan-fried fruit

November 13, 2021 0 Comments

 A simple recipe that requires only a few minutes of pan cooking and a lot of rest. A nice association with chopped hazelnuts.

A simple recipe that requires only a few minutes of pan cooking and a lot of rest. A nice association with chopped hazelnuts.



INGREDIENTS: 4 PERS.

1 Raw foie gras devetin of 600 g

7 g Smoked salt Viking Exotic Earth

1 g ground pepper

200 g Chopped hazelnut

For pan-fried fruit:

1 Physalis box

300 g Black grape

2 Pear

1/2 Lemon

1 tbsp Honey

1 tbsp Sherry vinegar

50 g Salted butter

Pepper

A simple recipe that requires only a few minutes of pan cooking and a lot of rest. A nice association with chopped hazelnuts.


Realization


  1. Mix the smoked salt and pepper. Detach the lobes, place them on film, season them on all their faces and pack them well before leaving them in the refrigerator for 2 hours. Take the lobes out of the refrigerator, cut them into slices about 2 cm thick, then pass them through the chopped hazelnuts, set them aside.
  2. Line a mold with parchment paper or food film to easily unmold the terrine. Heat a non-stick pan and grasp the slices of foie gras for 1 min on each side over low heat and then pack them flat into the mold as you go. Squeeze the terrine with a wood or cardboard wafer packed with food film to the dimensions of the mold and place a weight over the cooling time. Remove the press, cover, and store in the refrigerator 3 days before eating.
  3. Wash the grapes and pears. Cut slices of pears, drizzle them with lemon juice so that they do not oxidize. In a non-stick pan, melt the butter over high heat, add the fruit, mix and add the vinegar. after 3 min, add the honey, pepper and continue cooking over medium heat for 5 to 8 min. Adjust the seasoning to fleur de sel if necessary.

Christmas recipe: Pâté en croûte, stuffing duck and foie gras, pistachios and dried apricots

November 13, 2021 0 Comments

 Discover our superb recipe for pâté en croûte, duck stuffing and foie gras, pistachios and dried apricots. A festive starter that will amaze all your guests! To facilitate the demoulding of the pâté en croûte, preferably use a hinged mold.



INGREDIENTS: For 15 people


Utensils

The rectangular mold of 8 x 30 cm

Ingredients

For the dough:

400 g Flour

225 g Butter

1 Whole egg 1 yolk for gilding

80 g Water

Salt

For the stuffing:

500 g Duck needles

300 g Pork stuffing

300 g Raw duck foie gras

1 Egg

40 g Unsalted pistachios

5 Dried apricots

2 tsp Blend of 5 spices

10 cl Cognac

7 g Salt

2 g Pepper

For pickles:

1 Yellow onion

5 Small beets in 4 (or 8 depending on their size)

40 cl Water

25 cl Apple cider vinegar

125 g Sugar

1 tsp Anise seed

Pepper


Realization


  1. The day before, start this recipe for pâté en croûte by preparing the dough and marinating the meats. In the bowl of a robot, mix all the ingredients of the dough, except the egg yolk for gilding.
  2. Spread the dough coarsely, film it and reserve it in the cool.
  3. Chop the duck with a knife and then mix with the pork stuffing. Add the salt, cognac, spices, and pepper. Mix, cover, and reserve in the refrigerator for 24 hours.
  4. The day before spread the dough on a thickness of about 5 mm, reserve a quarter for the lid. Line with baking paper and butter the mold. Cut a rectangle of dough so as to line the entire width of the mold by going up to the edges. Place this rectangle in the mold and line the walls with dough over the entire height, letting the surplus protrude on each side. Then detail two pieces to line both ends of the mold. Make them a little larger than the part to be filled so that they can be soldered to the dough already in the mold. You can slightly moisten the dough so that it adheres better. Keep the falls for decoration.
  5. Preheat the oven to 220°C.  Take the meat out of the refrigerator, add the egg, pistachios, and apricots cut into pieces, knead. Cut the foie gras into 1.5 cm slices, salt, and pepper.
  6. Squeeze half of the stuffing into the mold, cover slices of foie gras all over the surface, and then the rest of the stuffing, tamp well. Fold the edges over the stuffing, brush with egg yolk. Spread the dough reserved for the lid, cut a rectangle the size of the mold. Cover the pate and carefully weld the edges. Make three holes on the lid and make fireplaces with parchment paper. Make shapes with a knife or the rest of the dough to decorate and then brush with egg yolk.
  7. Bake for 15 min, then lower the temperature to 180 ° C and continue cooking for 45 min. Let the pâté cool before unmolding it and then refrigerate it for 24 hours.
  8. On the same day, take out the pâté 30 minutes before tasting it or put it in the oven for a few minutes to serve it warm. Accompany it with pickles of small beets and onions.

covid 19:Sanofi vaccine release date and specifics of this new vaccine

November 13, 2021 0 Comments

 The international Phase III study of the Sanofi vaccine aims to evaluate the safety, efficacy, and immunogenicity of a vaccine candidate: it began on May 27, 2021, for the Sanofi recombinant protein vaccine. It could therefore be approved in the fourth quarter of 2021, subject to convincing results from this phase III as well as regulatory evaluations.


This vaccine may be useful, in particular as a possible booster after two doses of mRNA vaccine, but also to participate in the vaccination campaign of the world population, a little less than a quarter of whom are, to date, vaccinated.

covid 19Sanofi vaccine release date and specifics of this new vaccine


Context of Covid-19 vaccination

The Covid-19 pandemic is an unprecedented global health crisis.


A French transnational company whose activities include pharmaceuticals and vaccines, Sanofi ranks third in the world in the healthcare sector by turnover. Its global Vaccines entity is based in Lyon and is called Sanofi Pasteur. She is currently working on two Covid-19 vaccine candidates that use two different technologies. It is, on the one hand, an adjuvanted vaccine based on recombinant proteins, and, on the other hand, a messenger RNA vaccine (the same technology as the Pfizer and Moderna vaccines).


What is the principle of the Sanofi vaccine?

According to Our World in Data, only 24.6% of the world's population is currently fully vaccinated. In addition, large disparities remain in terms of immunization between, on the one hand, the richest countries and, on the other, the countries with lower incomes.


In this context, the arrival of a new vaccine, in this case, the very first French vaccine with Sanofi, is scheduled for the end of the fourth quarter of 2021, subject to the results of the phase III clinical trial.


This vaccine called Vidprevtyn could help boost the vaccination campaign around the world. Especially since recombinant proteins, the technology used by this vaccine candidate, is easier to preserve than other vaccines such as those based on mRNA technology.


Operation and principle of action

Sanofi and GlaxoSmithKline (or GSK, a British pharmaceutical company), have launched since May 27, 2021, the third phase of clinical trials of their recombinant protein vaccine candidate against Covid-19.


It is a protein-based vaccine: it contains a version of the Spike protein grown in the laboratory. This vaccine under development is based on the same technology used for one of Sanofi's seasonal influenza vaccines, with the flu protein being replaced by the Spike protein. This protein is present on the surface of SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2, which is the coronavirus at the origin of Covid-19), it allows the coronavirus to enter human cells, including those of the lungs. Once entered a cell thanks to Spike, the virus reproduces, before spreading to other cells in the body.


In fact, this recombinant protein vaccine candidate from Sanofi is based on innovative technology. Its purpose is to induce an immune response that will allow the human body to fight against the Covid-19 virus. GSK produces adjuvants for pandemic use.


When a person receives the vaccine, their body identifies the Spike protein as foreign and makes antibodies against it. If later, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognize the viral protein and be ready to defend the body against the virus.


The principle of this proven technology is as follows:


  1. To make the vaccine, scientists copy the DNA sequence of the Spike protein in the lab.
  2. Then, they introduce this DNA sequence into a circular fragment of DNA called a plasmid: it is, therefore, a recombinant DNA since it recombinants several DNA fragments.
  3. This plasmid carries the DNA sequence of the Spike protein into a baculovirus, which is a kind of delivery system used for the manufacture of the vaccine.
  4. In parallel, scientists are developing cells in culture: these will serve as a production platform. Baculovirus can then enter these cells and reproduce there.
  5. This results in the production of multiple identical copies of the Spike protein.
  6. The scientists will then extract the Spike proteins, purify them before gathering them in batches, formulating them, and packaging them into vials. This vaccine candidate must be combined with an adjuvant that will boost the immune system so that it defends itself, via the production of antibodies against the Spike protein.
  7. If the vaccine is injected into the body, the immune system will detect the Spike protein and produce antibodies that can identify and bind to it.
  8. The immune system reacts to the vaccine. It memorizes the Spike protein. And so, when the body encounters the complete SARS-CoV-2 virus, it will remember that it must generate new antibodies in order to fight the virus. It is this process of memorization that allows a vaccine to provide more long-lasting protection against the disease.

The safety and efficacy of this vaccine is currently still being evaluated by a regulatory authority.


Composition

The vaccine candidate developed by Sanofi-Pasteur and GSK, Vidprevtyn, consists of recombinant Spike proteins produced by Sanofi as well as an adjuvant produced by GSK. One dose of vaccine candidate contains, specifically, an amount of 10μg of recombinant protein, combined with GSK's AS03 adjuvant.


Who can receive the Sanofi vaccine?

Phase III clinical trials of this vaccine are currently underway and involve 35,000 people aged 18 years and older. This is a randomized, double-blind study. Some participants in this study receive the vaccine candidate, others the placebo.


These clinical trials are conducted in different locations around the world: the United States, Asia, Africa and Latin America. This phase III study will therefore make it possible to evaluate, in adult individuals of different ages, to evaluate both the safety and the efficacy and immunogenicity of this vaccine based on recombinant proteins. Depending on the results, the Sanofi vaccine could hit the market for a variety of audiences, potentially starting in the fourth quarter of 2021.


What is the dosage of the Sanofi vaccine?

What is the recommended duration between the 2 injections?

It will also take two doses of the Sanofi vaccine for primary vaccination. For a booster vaccination, one dose will be sufficient. In phase II dose-finding trials, both injections were administered twenty-one days apart. The method of administration is intramuscular.


Should you get vaccinated when you have had Covid?

Phase II clinical trials of the recombinant Sanofi vaccine candidate have demonstrated elevated antibody concentrations observed in participants who have already been infected following the administration of a single dose of this vaccine candidate. They thus suggest that such a vaccine could be useful for vaccination after having already been infected with Covid-19, but also for a booster vaccination.


How is the Sanofi vaccine stored?

Proteins turn out to be relatively stable molecules. This is why a candidate vaccine designed from purified Spike proteins can be stored at a temperature of 2 to 8°C.


Is the Sanofi vaccine effective?

Protection against covid-19

The percentage efficacy of the Sanofi vaccine will be determined during the ongoing Phase 3 clinical trial. This vaccine candidate has been manufactured to generate a consistently high immune response. In addition, it could potentially stop viral transmission, as reported by the Clinical Trials Arena website.


In fact, the interim phase II results are already known: they indicate that the recombinant adjuvanted vaccine candidate triggered a strong immune response in adults of all age groups. For this, seroconversion rates were between 95% and 100%. In addition, high concentrations of neutralizing antibodies were produced, at levels comparable to those generated by a natural infection.


Protection against variants

The Phase III clinical trial is designed in two stages:


The first step

It aims to determine the efficacy of a vaccine formulation targeting the original Wuhan variant (D.614).


The second step

This one will investigate a different formulation using the South African variant (i.e. The Beta variant, B.1.351).


However, in fact, as evidenced by recent scientific data, the antibodies generated against the South African variant could offer broader cross-protection and therefore protection against other variants that are more transmissible. The design of this clinical trial, therefore, has the objective of also testing the effectiveness of the vaccine against different variants in circulation.


1 dose: limited efficacy?

To be effective, the vast majority of vaccines require boosters, because otherwise, their effectiveness is not optimal. And so, for Sanofi's vaccine, it is the injection of two doses that are currently being tested for primary vaccination.


A single dose could be useful either as a booster after vaccination with another vaccine, for example, an mRNA vaccine, or in people who have previously been infected with Covid-19.


What are the side effects of the Sanofi vaccine?

In a statement, Sanofi announced that with respect to adverse reactions to this recombinant protein vaccine candidate, "the safety profile is acceptable and does not raise safety concerns."


The results of phase III clinical trials will make it possible to better determine, in particular, the safety of this vaccine and the nature of its side effects.


What are the differences with other vaccines on the market?

Sanofi vs Pfizer or Moderna

The technology of these vaccines is different, since Sanofi uses that of recombinant proteins, while the Pfizer vaccine, like Moderna's, uses messenger RNA technology.


Thus, the difference between these two types of vaccines is that, in the case of Sanofi, the vaccinated person is injected directly with a Spike protein produced by biotechnology, combined with an adjuvant that stimulates the immune response, while in the case of Pfizer (or Moderna), it is the messenger RNA encoding the Spike protein that is injected,  thus causing the body's cell itself to produce the Spike protein that will trigger the immune response. An important difference is also that the Sanofi vaccine requires the addition of an adjuvant, whereas messenger RNA technology does not.


Sanofi vs Astrazeneca and Janssen

Again, the two technologies diverge between Sanofi's vaccine candidate and the Astrazeneca or Janssen vaccines. For this, the technology of the AstraZeneca vaccine and that of the Janssen vaccine uses an adenoviral vector.


The Spike protein is not injected directly in combination with an adjuvant, as with Sanofi's Vidprevtyn vaccine, but this Spike protein, in the case of AstraZeneca or Janssen vaccines, is expressed by means of an adenovirus, which is a recombinant chimpanzee virus. It should also be noted that the Sanofi and AstraZeneca vaccines require, for primary vaccination, two doses of vaccines while that of Janssen requires only one.


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Nov 11, 2021

covid 19 Pfizer: efficacy, side effects, 3rd dose

November 11, 2021 0 Comments

 Based on the innovative messenger RNA technology, the Pfizer vaccine received its marketing authorization from the European Union on 21 December 2020.

covid 19 Pfizer  efficacité, effets secondaires, 3ème dose


In France, the first doses injected, in elderly patients, the most at risk of developing a severe form, began on December 27, 2020. In total, 600 million doses of the Pfizer BioNTech vaccine have been ordered by the European Union for the year 2021.


This reveals a 95% effectiveness in preventing severe forms of Covid-19, but this effect may decrease in mutated viruses, called variants.


Context of Covid-19 vaccination

It was at the end of 2019 that the first cases of a new respiratory disease quickly baptized Covid-19, appeared in China, in the city of Wuhan.


Caused by a coronavirus, SARS-CoV-2, this emerging pathology has spread around the world, causing a pandemic that has caused many deaths, and has caused several periods of confinement in many parts of the world.


In France, at the end of August 2021, the High Authority for Health counted a total of more than 114,000 deaths. In addition, long forms of the disease also appeared, causing symptoms that can persist for several months, even in relatively young subjects and without comorbidities.


It is in this context that the first vaccines appeared in the course of 2020. And so, Pfizer, an American laboratory founded in 1849 and which currently has nearly 92,000 employees worldwide, has partnered with the German biotechnology company BioNTech, created in 2008, to launch the very first vaccine against Covid-19.


What is the principle of the Pfizer vaccine?

Operation and principle of action

The Pfizer-BioNTech vaccine is called Cominarty. It is a vaccine based on messenger MRA technology, an innovative technology that is based on a long scientific history: indeed, researchers have been working on the subject for several decades.


Usually, the principle of a vaccination is to inject an attenuated or inactivated form of an infectious agent or some of its components into the body. The goal is, thus, to prepare it for further contact with a pathogen. Indeed, this vaccination causes the development of immune cells called 'memories', which will immediately recognize the pathogen if the individual were to be exposed to it naturally. 


What is a messenger RNA vaccine?

The principle of these new so-called messenger RNA (Ribonucleic Acid) vaccines is a little different since they consist in making the fragments of infectious agents produce directly by the cells of the vaccinated individual. It is therefore not, in this case, the virus in its attenuated form that injects, but only the RNA molecules encoding proteins of the pathogen. The cells that are located near the injection site, essentially muscle cells and cells of the immune system, will then make the proteins of this pathogen themselves, in this case, fragments of the Spike protein. These were chosen upstream because they trigger a significant and protective immune response.


In fact, the Spike protein is indeed a key molecule of SARS-CoV-2: present on its surface, it allows the virus to cling to cells before penetrating and then infecting them.


The Pfizer BioNTech vaccine induces both neutralizing antibody production and cellular immunity in response to the Spike antigen produced by the body's cells from injected mRNAs.


Composition of the vaccine 

The vaccine is therefore made up of messenger RNA fragments, which are transported by lipid particles to the right place, inside the cells of interest. These nanolipid particles that carry vaccine messenger RNA have a composition similar to that of lipids located in the membranes of all cells of our body and therefore pose no risk.


In addition, RNA is, like DNA, a molecule naturally present in all cells of living beings. Indeed, DNA, which is located in the nucleus, carries the genetic heritage of any individual. As for RNA, it is synthesized from DNA fragments and is used as a pattern by complex cellular machinery (including ribosomes), to make all the proteins necessary for the functioning of the body.


Choosing an RNA vaccine over a DNA vaccine

This choice is important: indeed, it allows the Spike protein to be produced directly in the cytoplasm of the cells of the vaccinated person, that is to say by the part of the cell that surrounds the nucleus, and thus prevents this molecule from entering the nucleus. These vaccines are potentially better tolerated since they do not rely on whole viruses. In addition, they do not use any adjuvant, but only nucleic acid molecules (the famous RNAs). The RNA contained in the vaccine will thus play a dual role: to express the viral protein and to stimulate the immune system without adjuvant.


This messenger RNA is produced using cells in vitro transcription from the corresponding DNA matrices and encoding the viral Spike protein of SARS-CoV-2. The drug is provided in a multidose vial. It should be diluted before use: for this reason, one 0.45 ml vial contains six doses of 0.3 ml after dilution. One dose, or 0.3 ml, contains 30 micrograms of mRNA vaccine encapsulated in lipid nanoparticles. The vaccine also contains excipients.


Who can receive the Pfizer vaccine?

Children over 12 years of age and adults

Adolescents between the age of 12 and 18 as well as adults can receive the Pfizer vaccine.


Marketing authorization in Europe was granted on 21 December 2020 for all adults and adolescents over 16 years of age. This MA has been extended to adolescents aged 12 to 15 years from 10 June 2021. In France, the HAS issued a favourable opinion on 3 June 2021 for the use of this vaccine among adolescents between 12 and 15 years of age. The overall safety profile in adolescents assessed in two clinical studies involving a total of 22,975 participants was similar to that observed in participants aged 16 years and older.


Seniors and over 55 years of age

Advanced age is the main risk factor for severe Covid-19 and therefore hospitalization. However, the Phase 3 clinical trials that led to the commercialization of these vaccines were under-represented of older people. The first French data published on May 21, 2021 by EPI-PHARE (public expert group in the epidemiology of health products) on the effectiveness of the Pfizer-BioNTech vaccine show an effectiveness that seems excellent in elderly subjects, with a protection rate of at least 90% for 75-85 year olds and at least 80% for those over 85 years old. 


Pregnant women

According to data from the World Health Organization (WHO) updated at the end of June 2021, pregnancy puts women at a higher risk of severe Covid-19, but currently, very little data exists to assess the safety of the vaccine during pregnancy.


Pregnant women at high risk of exposure to SARS-CoV-2 (e.g. Health workers) or with comorbidities that increase the risk of developing a severe form of the disease can be vaccinated in consultation with their caregiver. Thus, in pregnant women, the vaccine should only be considered if the potential benefits outweigh the potential risks to the mother and fetus. The website of the Ministry of Health indicates a possible vaccination for pregnant women from the second half of pregnancy.


People with comorbidities

For the WHO, "the Pfizer BioNTech vaccine has proven its safety and efficacy in people with different conditions associated with an increased risk" of the severe form of the disease.


Among these co-morbidity factors are mentioned:


  1. high blood pressure;
  2. diabetes;
  3. asthma;
  4. lung diseases;
  5. hepatic or renal;
  6. as well as chronic infections under control.

 Are there any precautions for use and contraindications?

Prevention

The vaccinated person should be monitored for fifteen minutes after vaccination. In addition, a second dose should be avoided in the event of an anaphylactic (i.e. Allergic) reaction that occurred following the first dose.


Contraindications

The Pfizer BioNTech vaccine is contraindicated in case of hypersensitivity to the active substance or to any of its excipients.


For information, here is the list of excipients contained in this vaccine:


  1. ALC-0315, ALC-0159, DSPC;
  2. cholesterol;
  3. potassium chloride;
  4. monopotassium phosphate;
  5. sodium chloride;
  6. disodium phosphate dihydrate; 
  7. sucrose;
  8. Water for injection.

What is the dosage of the Pfizer vaccine?

What is the recommended duration between the 2 injections?

If a protective effect begins to appear twelve days after the first injection, two injections are necessary to ensure complete protection. The recommended duration between the two injections, according to WHO recommendations, is 21 to 28 days.

In fact, in France, the usual time between the two injections of the Pfizer vaccine varies from four to six weeks, but during the summer of 2021, this interval was able to extend from three to seven weeks.

Should you get vaccinated when you have had Covid-19?
The High Health Authority indicated, in an opinion issued on 11 February 2021, that people who have already had Covid-19 can be given a single dose of vaccine. Indeed, people who have already been infected retain an immune memory. Thus, this single dose of vaccine, therefore, plays the role of 'booster' following infection.

In addition, people who have received the first dose of vaccine and who have coronavirus infection (PCR, antigenic or serological test positive) should not receive the second dose within the usual time frame. They must wait at least two months after the end of the symptoms before proceeding with the vaccination.

Third booster dose: why is it recommended?

After analyzing the available data, the HAS published on August 24, 2021, an opinion: it recommends a booster dose, the injection of a third dose with an mRNA vaccine, for people aged 65 and over as well as for people with comorbidities because these increase the risk of presenting a severe form of Covid-19. In fact, this booster dose will be administered after a period of at least six months following the primary complete vaccination.

The HAS justifies this decision given that "recent studies suggest a reduction in the effectiveness of all vaccines, especially against the delta variant". In addition, "the decline does not only affect the elderly and populations at risk of severe illness, but the latter remains the most affected". This opinion of the HAS was issued at the request of the government to allow the organization and anticipation of the recall campaign. However, it remains conditional on the validation of this recall by the European Medicines Agency. Finally, the third dose is also indicated for highly immunocompromised people.


How is the Pfizer vaccine stored?

The Pfizer BioNTech vaccine can be stored for six months at very low temperatures, between -60 and -90 degrees.

Pfizer has created a thermal container: it guarantees the safety of its vaccine during transport and storage, at a temperature between -25 and -15°C for a single period of up to two weeks and can then be returned to a temperature of -60 to -90°C.  When thawed, the uninsured vaccine keeps between 2 and 8 degrees for a month. Before use, the unopened vial can be stored for a maximum of two hours at temperatures up to 30°C.


Is the Pfizer vaccine effective?

Protection against covid-19

The protective efficacy of the Pfizer vaccine in preventing Covid-19 is estimated at 95%. As with any vaccine, not all people vaccinated with Cominarty may be protected. It takes seven days after the injection of the second dose of vaccine before the vaccinated persons are optimally protected. Estimated efficacy values have similar values based on gender, ethnic group, as well as in vaccinated individuals with comorbidities associated with a high risk of severe Covid-19.

The duration of protection conferred by the vaccine is not established. It is still being evaluated.

A study conducted in Israel

A study on the data of nearly 600,000 people who received the Pfizer-BioNTech vaccine versus a control group of as many people was conducted in Israel, a country that began its vaccination campaign quickly and has significant coverage of its population.

This study confirmed the high efficacy of this vaccine. Thus, a week after receiving their second dose of vaccine, a person is ten times less likely to be unknowingly infected and potentially transmit the virus. But the major result of the study is the demonstration of a drastic reduction in mortality: indeed, it is reduced by 72% two to three weeks after the first dose and one week after the second dose, no deaths have been recorded.

Protection against variants

The SARS-CoV-2 genome, like that of other coronaviruses, is made up entirely of RNA. This sequence of four nucleotides (adenine, guanine, cytosine and uracil) can undergo mutations: thus, one or more of its nucleotides can be added, replaced or removed, and this randomly. In total, a few dozen lineages would exist at different scales in the world.

Interviewed by the Journal du CNRS, Bruno Lina, a researcher at the International Center for Research in Infectiology, mentions "in the jargon of virologists, we speak of variant only when mutations affect the antigenic response of the virus. Antibodies that react with the original virus no longer do so as well, if at all, with the variant.'

The Delta variant

Very contagious, the Delta variant spreads quickly, despite the acceleration of the vaccination campaign, especially since the announcements on the health pass. The efficacy of the Pfizer vaccine against the Delta variant, after one dose, is estimated at 35.6%, and after two doses, is estimated at 88%, according to data from the NEJM (New England Journal od Medicine) which estimated the risk of contracting a symptomatic form of Covid-19 in vaccinated patients, compared to unvaccinated.


The Alpha variant

Commonly known as the British variant, the Alpha variant has also been studied in the NEJM and thus, the effectiveness of the Pfizer vaccine against this variant is 47.5% after one dose and rises to 93.7% after two doses.

The South African variant

The Vidal website specifies that the protection, fourteen days after the second dose of vaccine, against any form of infection by the South African variant, amounts to 75%. The authors of a study published in the NJEM and carried out in Qatar point out that "while the effectiveness of the Pfizer vaccine on the South African variant is well below the effectiveness of the vaccine against the virus of the origin or the English variant, it nevertheless confers a very high level of protection against severe forms of infection".

The Brazilian variant

Concerning the Brazilian variant also (also called Gamma variant) mRNA vaccines have a retained but decreased efficacy. And in fact, according to an American study published by researchers in Massachusetts, mRNA vaccines are "significantly less effective" against variants, and in particular against the Brazilian strain.

Pharmaceutical companies manufacturing vaccines, such as BioNTech or Moderna, are now developing new versions of their vaccine, which will be adapted to the different variants.

1 dose: limited efficacy?

A study published in The Lancet showed that after a single dose of Pfizer vaccine against Covid-19, the body is less likely to produce protective antibodies, called neutralizing, especially against the Indian, English, and South African variants. In fact, the first dose introduces the targeted antigen into the body, while the second injection strengthens its action and prolongs the duration of the immune response. This is especially true for messenger RNA vaccines. Professor William Petri of the University of Virginia told futurasciences that "these vaccines need a booster to reactivate T cells, which in turn will stimulate antibody-producing B memory cells."


What are the side effects of the Pfizer vaccine?

When do the first side effects of the vaccine appear?

The first side effects of the vaccine may appear within a quarter of an hour after the injection and in the days that follow.

The National Agency for the Safety of Medicines (ANSM) has, on this point, indicated that "most of the adverse reactions reported during the clinical trials conducted on the BioNTech vaccine were adverse reactions of mild to moderate intensity disappearing spontaneously within a few days".

Very common symptoms

There are very common symptoms, which can be greater than one in ten cases:

  1. headache; 
  2. diarrhea; 
  3. arthralgia and myalgia;
  4. pain at the injection site;
  5. fatigue;
  6. chills;
  7. fever;
  8. swelling at the injection site.

Common symptoms

These symptoms occur in less than one in ten cases, but more than one in a hundred:

  1. nausea, vomiting;
  2. redness at the injection site;

Uncommon symptoms

  1. lymphadenopathy;
  2. hypersensitivity reaction;
  3. In addition, cases of anaphylaxis (severe allergic manifestation) have been reported.
The anaphylactic reaction should be immediately treated by intramuscular injection of epinephrine. The median interval of occurrence of this symptom is 13 minutes (between 2 and 150 minutes).

Symptoms with undetermined frequency

Other symptoms may also appear in very rare cases:

  1. Myocarditis;
  2. Pericarditis;
  3. Extensive swelling of a vaccinated limb;
  4. Swelling of the face.

Our tips to reduce and avoid possible side effects

Side effects of the Pfizer vaccine remain mild in the vast majority of cases. It is not recommended to take paracetamol as a preventive measure. The small ailments sometimes caused by vaccination are just a sign that the body's immune response is starting.

It is especially advisable to avoid drinking alcohol for three days after each injection. A study published in Nature in 2012 showed that excess alcohol can act as an immunosuppressant and affect the effectiveness of a vaccine.

What to do in case of emergency?

In case of emergency, call the UAS or go to the emergency department of the nearest hospital.

No transmission to the genome or offspring

The RNA injected via the vaccine poses no risk of transforming our genome or being transmitted to our offspring, since it does not penetrate the nucleus of cells. However, it is in this cell nucleus that our genetic material is located. In addition, under no circumstances does RNA travel to the cells of the reproductive organs.


What are the differences with other vaccines on the market?

Pfizer vs Moderna, which one to choose?

The Pfizer and Moderna vaccines have a similar mode of action: both are based on the so-called mRNA technology. In addition, their performance is very close since that of the Pfizer vaccine amounts to 95% while that of Moderna puts forward a figure of 94.1%. Their quality thus seems almost equivalent.

Pfizer or AstraZeneca?

The principles of the Pfizer and AstraZeneca vaccines, on the other hand, differ, given that the Astrazeneca vaccine uses an adenoviral vector. Indeed, the Spike protein is not expressed by means of a messenger RNA, but from an adenoviral vector, which therefore uses a recombinant chimpanzee virus. It is this adenovirus that will express the Spike protein of Sars-CoV-2. Studies estimate the performance of the Astrazeneca vaccine at 70.4% on average.

Pfizer: the differences with Janssen

The Janssen vaccine technology, unlike Pfizer, is also based on a specific adenovirus, which has been genetically modified so as not to replicate in humans and cause disease. This adenovirus is used as a vector, i.e. Transporter, of the genetic code of an antigen. Harmless parts of the virus are used as antigens and cause an immune response similar to that of the virus, but without causing a serious reaction.

According to the WHO, Janssen's vaccine has an efficacy of 85.4% against severe forms of Covid-19 as well as hospitalization related to this pathology. In addition, the results of clinical trials have indicated that one dose of the Janssen vaccine has an efficacy of 66.9% against symptomatic infection with moderate or severe SARS-CoV-2.

Differences with Sanofi

Sanofi's vaccine, called Vidprevtyn, is based on the same recombinant protein-based technology as Sanofi's flu vaccines. This recombinant protein is combined with an adjuvant (produced by GlaxoSmithKline, GSK) to stimulate the immune system.

The vaccine is currently under continuous review by the European Medicines Agency, the EMA. For the EMA, "the results suggest that the vaccine triggers the production of antibodies targeting Sars-CoV-2 and could help protect against the disease."

This vaccine is expected to be approved in the fourth quarter of 2021, subject to positive Phase III results and regulatory evaluations. Recombinant protein technology can produce very large amounts of antigens, with the proteins then injected to stimulate the immune system's response against the virus.

12 Reasons Why You're Always Tired

November 11, 2021 0 Comments

 For some time now, you have noticed that you are always tired, no matter how many hours you spend in bed? It may be time to get rid of one of those 12 bad habits that are often overlooked and responsible for chronic fatigue.

12 Reasons Why You're Always Tired


You don't drink enough water

Although water is essential to all vital processes of the body, many neglect it.

They don't know how wrong they are: several studies have shown that chronic dehydration affects mood, significantly increases fatigue, and decreases alertness1. That is why (among other things) it is advisable to drink 2-3 liters of water per day, or even more in case of intense physical training.


You have dietary deficiencies

Several nutrients – including iron, zinc, calcium, magnesium, and B-complex vitamins – play an important role in the chemical balance of the brain.

A deficiency in either of these nutrients can lead to a decrease in sleep quality and therefore a feeling of fatigue. In case of persistent fatigue, it may therefore be relevant to do a complete blood test to detect nutrient deficiencies.


You don't do enough exercises

Several studies have found a correlation between lack of exercise, chronic fatigue, and low cortisol levels.

Quickly, we fall into a vicious circle: fatigue discourages the individual from practising physical activity, which reinforces the feeling of fatigue. It is recommended to practice the equivalent of at least 1 hour of brisk walking per day.


You don't eat enough in the morning

While recent studies have shown that breakfast is not essential in itself (and that it does not allow you to lose weight), it is recognized that eating in the morning is beneficial for physical and cognitive performance.

Glucose deprivation caused by fasting for several hours leads to a drop in blood glucose, quickly followed by disturbances in brain function1: attention is slowed down.

Starting early in the day without having a snack can therefore explain a feeling of fatigue throughout the morning.


Your workspace is not tidy

This may seem strange: an unsigned desk could restrict your ability to concentrate and increase the feeling of fatigue1...

To avoid this, nothing could be simpler: at the end of each day, be sure that nothing is lying around on your desk so that you can ideally start the next day. Above all, do not wait to be overwhelmed by a disorder before taking matters into your own hands!


You are to perfectionist

Perfectionism is a personality trait that can quickly lead to burnout.

Unrealistic goals, fear of failure, and excessive self-criticism are all factors directly related to poor restful sleep and fatigue at all times.

If you are in this case, several tips are available to you: make an appointment with yourself (through a journal for example), set priorities (and stick to them), limit your time...


You snore and have sleep apnea

It should be known, snoring, sleep apnea, can harm sleep insidiously and cause chronic fatigue.

If multiple factors are at play, the frequency of sleep apnea is 12 to 30 times higher in people with obesity. A loss of 7 kg may be enough to reduce snoring and improve sleep. Snorer as well as a partner!


You don't know how to say no

Still, feeling overwhelmed? Do you feel like you never give your opinion, that you are suffering, that you are being crushed?

Perhaps you suffer from an inability to say no, in your private life as well as in your professional environment. If this is the case, look no further: this "disability" is probably one of the culprits of your chronic fatigue, as several studies have shown.


You abuse your sleep on weekends

Every Monday, it's the same song: you feel tired and have trouble getting up. And for good reason! You have the feeling that you have only managed to sleep a few hours. This is not an impression: it seems that the night from Sunday to Monday is the least conducive to falling asleep and restful sleep.

This is simply explained by the upheaval in the sleep rhythm caused by the two days of rest: for many, Friday and Saturday nights are an opportunity to go to bed later and therefore to sleep in. The body is out of control and makes you pay for it, it's the same mechanism that operates when you experience jet lag.


You use your mobile phone in bed

Looking at your phone, tablet, or e-reader in bed is not recommended if you want to get a good night's sleep.

The light released by these devices slows down the production of melatonin (sleep hormone). The direct action of the light delivered by a screen stimulates the visual pathways and acts on the internal biological clock when viewed1.

According to a study2, looking at the screen of an electronic device before bed reduces the quality of sleep. In the long term, this use is harmful and can cause significant sleep disorders, which severely affect daily life. A possible solution: use filters that block the blue light emitted.


You ingest too much caffeine during the day

 The Caffeine found in coffee, tea, chocolate, and energy or soft drinks should be avoided before going to bed. It persists in the body between 3 and 5 hours and disrupts sleep cycles.

One study1 showed that consuming a drink that contains caffeine between 0 and 6 hours before bedtime significantly reduced sleep duration. Indeed, even when consumed 6 hours before bedtime, it would lose nearly an hour of sleep!


You consume alcohol in the evening

Do you think alcohol makes it easier to fall asleep? Undoubtedly, but in reality, it significantly reduces the quality of sleep.

This is because drinking alcohol after dinner can blow up the first sleep cycle, which is called calm wakefulness. During it, the brain is still active, but the body relaxes. Alcohol also causes regular awakenings due to adrenaline secretions and disrupts sleep cycles because it blocks the entry of tryptophan into the brain.

In addition, since it dehydrates, it frequently happens that the person wakes up in the middle of the night to drink a glass of water. Sleep is, therefore, less regenerative and less restful.