As the European Union threatens to block exports of the AstraZeneca vaccine to France, the mayor of Paris Anne Hidalgo calls for the opening of the vaccination to all those who wish it. Efficacy, differences, side effects, principle, doses, age, storage ... Update on Covid-19 vaccines.
Four vaccines are authorized in Europe: that of Pfizer - BioNTech - the first to be validated on December 27, 2020, that of Moderna, AstraZeneca, and Johnson & Johnson, which should arrive in April in the EU according to the President of the European Commission Ursula Von der Leyen. Those of the Russians, Sputnik V, and the Germans, CureVac, are still being reviewed by the European Medicines Agency.
While a dozen European countries have suspended vaccination with AstraZeneca following cases of thrombosis(including deaths), the European Medicines Agency confirmed Thursday, March 18 that this vaccine is "safe and effective" and that "its benefits outweigh its side effects". While acknowledging that it may be associated with "very rare cases" of blood clots, the EMA recommends that patients vaccinated with AstraZeneca watch for symptoms such as shortness of breath, chest pain, or chest pain. stomach, swelling, or cold in an arm or a leg ... and seek immediate medical attention in this case.
Friday, the High Authority of Health has, in turn, given the green light to the resumption of vaccination in France "without delay" by restricting it to people aged 55 and over. What are the differences between these vaccines? In their administration? Their number of doses? Their effectiveness and side effects according to clinical trials? What are the future vaccines to be authorized in Europe? How is the vaccination going in France? Are vaccines effective against variants? Up-to-date info.
10 million French people vaccinated. On BFMTV, this Sunday, March 21, the government spokesperson, Gabriel Attal, maintains the target of 10 million French people vaccinated in mid-April, and 30 million for mid-June.
Acceleration of vaccination. On Europe 1, this Sunday, March 21, the mayor of Paris, Anne Hildago, felt that it was necessary " now to unleash vaccination for all those who want to be vaccinated ".
The EU threatens to block AstraZeneca's exports. " We have the option to ban any planned exports. This is our message to AstraZeneca: respect your contract with Europe before you start delivering to other countries, " said the President of the European Commission. , Ursula von der Leyen, in an interview with German media group Funke, Saturday, March 20.
Jean Castex vaccinated. Aged 55, Prime Minister Jean Castex received his first dose of the AstraZeneca vaccine on Friday afternoon at the Bégin hospital in Saint-Mandé, as he had announced during the press conference on March 18. “I didn't feel anything even though I was a little cozy,” he commented.
Finland suspends AstraZeneca. Finnish health authorities announced on Friday the suspension of vaccination via AstraZeneca. "Under the precautionary principle", the Finnish Public Health Authority (THL) has decided "to suspend injections in Finland until there is more information and a possible causality can be assessed ". A decision taken despite the favorable opinion of the EMA issued the day before.
HAS gives the green light to AstraZeneca in France. " Following the opinion of the EMA, HAS gives green light to the resumption of vaccination with AstraZeneca for those 55 and over. Thanks to all doctors, pharmacists today will all mobilize to continue the vaccine campaign " declared Olivier Véran on his Twitter account on Friday. The High Authority of Health (HAS) gave the green light to the resumption "without delay" of the vaccination with AstraZeneca, but recommends to reserve it to people of 55 years and more, in a notice published this Friday, March 19.
Vaccination of French people abroad. French people residing in a country where they cannot be vaccinated with a vaccine validated by the EMA will be able to "be vaccinated in France during their passage" indicated the Secretary of State in charge of French citizens living abroad Jean- Baptiste Lemoyne. "84% are eligible for local vaccination devices with vaccines approved by the European Union," he said on RFI on Friday.
Russian vaccine validated in the Philippines. Russia's Sputnik V coronavirus vaccine has been "procedurally approved for emergency use" in the Philippines, the Russian Sovereign Wealth Fund said on Friday.
Russian vaccine produced in India. The Russian Sovereign Fund announced on Friday that it had reached an agreement with an Indian pharmaceutical group to produce at least 200 million doses of its Sputnik-V vaccine there.
The EMA re-validates AstraZeneca. On Thursday, the European Medicines Agency ruled: "The benefits of the vaccine in tackling the still widespread threat of COVID-19 (which itself causes bleeding problems and can be fatal) continue to outweigh the risk of side effects ". The EMA recognized that it could be associated with "very rare cases of blood clots" and thus ask vaccinated patients to consult their doctors in the event of suggestive symptoms: shortness of breath, pain in the chest or stomach, swelling. or cold in an arm or leg, severe or worsening headache or blurred vision after vaccination, persistent bleeding, multiple small bruises, reddish or purplish spots, or blood blisters under the skin.
Over 70% of adults vaccinated in the EU at the end of summer and Johnson & Johnson in April? "It was a tough start. We are now making progress on vaccination. BionTech-Pfizer and Moderna are on contract. The first Johnson & Johnson vaccines will arrive in April. We can meet our goal of getting 70% of adults fully vaccinated by now. the end of summer." said Ursula Von der Leyen, President of the European Commission on Twitter.
What are the names of the Covid-19 vaccines?
Four vaccines are authorized in Europe:
- The Pfizer-BioNTech vaccine: COMIRNATY ®.
- Moderna's vaccine: Moderna COVID-19 mRNA or COVID-19 Vaccine Moderna.
- AstraZeneca vaccine: COVID-19 Vaccine AstraZeneca (for the manufacturer: AZD1222 or ChAdOx1 nCoV-19).
- Johnson & Johnson's Vaccine: COVID-19 Janssen Vaccine.
How do vaccines work?
The vaccines have different modalities of action, but they all target the Spike protein of the Sars-CoV-2 virus, which allows the virus to penetrate cells. Vaccination activates the immune system. "The germ that enters the body of a vaccinated person will collide with his immune system prepared to receive it", recalled Prof. Daniel Floret, a specialist in infectious diseases and vaccinology and vice-president of the Technical Committee for Vaccinations at HAS, May 7, 2020.
There are two types of vaccines:
Vaccine "sterilizing" makes it possible to interrupt the transmission of the virus (today, the vaccines authorized within the framework of the pandemic have not proved that they were able to prevent the transmission of the disease when a vaccinated person is infected).
The vaccine that protects against the disease but does not prevent the transmission of the infection: the vaccination could then be targeted on specific populations (this is the case of the Pfizer and Moderna vaccines which have proven their effectiveness against severe forms of Covid -19 hence the fact that they are first recommended to the oldest people).
"To develop a vaccine against a viral disease, it is necessary to know the virus which is at the origin since the vaccine will be made from certain parts of the virus which will make our immune system react" recalls the LEEM (a professional association which brings together drug companies in France) in a document dedicated to Covid-19 in July 2020. The vaccines developed against Covid-19 use different technologies:
Vaccine from attenuated or inactivated viruses (such as the Chinese vaccine): Vaccine containing infectious agents that are killed but capable of eliciting an immune system response. This type of vaccine requires large amounts of virus.
Vaccine from viral proteins: The coronavirus has spikes on its surface which allow it to come into contact with the cells to be infected. These spikes are viral proteins that could be isolated in the laboratory. They can be made and injected to make the immune system react to these foreign molecules.
Vaccine from DNA or viral mRNA (Pfizer / Moderna): A genetic sequence of the virus (DNA or mRNA) is injected and enters inside the human cell. This will use it to produce the associated viral protein which will make the immune system react.
Vaccine from viral vectors (AstraZeneca): A specialized attenuated virus (= vector) is used to convey the elements necessary for future protection (the protein (s) of interest and/or its sequence (s) genetic (s)) to our cells and thus expose them to our immune system.
How effective are they?
" The effectiveness of a vaccine can only be demonstrated over the long term, " explained to us at the start of the pandemic a spokesperson for the service of Pr Didier Raoult, Director of the IHU Méditerranée Infection . and not vaccinated against the virus have been exposed in a risk area so that it can be demonstrated that the vaccinated population has been less affected than the unvaccinated population. However, this necessarily takes a long time ". Today, after the start of vaccination, specialists agree that it takes at least 6 months to be able to analyze the antibody level of vaccinated people, a guarantee of their protection. In the leafletCorminaty® vaccine, the manufacturer Pfizer indicates that a delay of 7 days after the second dose of the vaccine may be necessary before vaccinated people are optimally protected.
Effective on what exactly? "The results of clinical studies of vaccine candidates seem to converge to demonstrate the main fact: vaccination can massively reduce mortality due to the virus and its severe forms " indicates the Ministry of Health in France on January 11, 2021. The efficacy of the vaccine sought today is, therefore, protection against the risk of serious forms, but it is not known whether it can protect against the transmission of the virus to other people. "For the vaccine strategy to be aimed at controlling the epidemic, it is necessary to wait for studies to establish proof that the vaccines have a possible efficacy on the transmission of the virus. and that the availability of vaccines is sufficient " indicated the HAS in its press release of November 30.
How long between doses?
The administration of vaccines against Covid-19 is done in two doses:
- 21 days apart for the Pfizer -BioNTech vaccine according to the manufacturers' recommendations.
- 28 days apart for the Moderna vaccine.
- spaced 9 to 12 weeks apart for AstraZeneca according to HAS recommendations (the manufacturer recommends between 4 and more than 12 weeks).
For people who have already been infected with Covid-19, the HAS indicated in a press release of February 12 that it was necessary to wait a minimum of 3 months before being vaccinated, or even to "get closer to 6 months and no more. 'use in this case that a single dose of vaccine (...) The single dose of vaccine will thus play a reminder role. " " People who have had an infection with SARS-CoV-2, confirmed by an RT test -PCR or antigen, whether or not they have developed asymptomatic form of Covid-19, must be considered as protected for at least 3 months by post-infectious immunity " explains the HAS. People who have already been infected keep immune memory.
What are the side effects?
Like any medicine, a vaccine can cause side effects. For the time being, according to reports from the National Medicines Agency in France, the side effects are mostly mild (fatigue, pain at the injection site, headaches) and temporary.
Are they allowed in pregnant or breastfeeding women?
Currently, there are insufficient data on pregnant women. Studies conducted in animals with mRNA vaccines (Comirnaty® or Moderna®) against COVID-19 have not shown any harmful consequences on the course of pregnancy or the development of the embryo or fetus. Animal studies are ongoing for the Astrazeneca® adenovirus vaccine. Preliminary results do not show any harmful effect on the development of the fetus. For the National Medicines Agency, "vaccination should be evaluated in pregnant women on a case-by-case basis, especially if they present comorbidity or are likely to.
in a pregnant woman, it is recommended to discuss this decision in close consultation with her doctor, her midwife, or her gynecologist in order to individually assess the benefit of the vaccination.
As a precautionary measure, while awaiting the final results of studies carried out in animals for the Astrazeneca vaccine, it is recommended to give preference to mRNA vaccines (Comirnaty® or Moderna®), for which animal studies have not been shown to affect the development of the fetus. In addition, flu-like syndromes, often severe in intensity, with high fever have been reported with the AstraZeneca vaccine.
If a pregnant woman has tolerated her first dose of vaccine poorly, regardless of the vaccine, it is advisable to postpone the second dose after the end of the pregnancy, in consultation with her doctor, midwife, or gynecologist.
If a first dose was administered while the pregnancy was still unrecognized, there is no worrying factor to date for the mother and the unborn child, regardless of the vaccine. If the first dose has been well-tolerated, the vaccination schedule can be continued normally.
For breastfeeding: there is no study on the passage into milk or in breastfeeding women but on the basis of biological mechanisms, "there is no expected effect in infants and children. breastfed by a vaccinated woman. Vaccination, in this context, especially if there are risk factors, must be discussed in close consultation with her doctor, midwife or gynecologist " indicates the ANSM.
Where are they produced?
Europe is the leader in vaccine production with 27 production sites in 11 countries of the European Union. Europe produces 1.7 billion doses of vaccines each year or 76% of global production. "The choice of production plants for the COVID-19 vaccine will depend on the type of vaccine to be produced and the technological process used" explains the LEEM. Several production sites can produce for several continents, just as the different production phases of a vaccine can be distributed over several sites (one site produces the antigen, one site conditions, etc.). The vaccines distributed in France can therefore be produced on several continents.
→ The Pfizer-BioNTech vaccine is produced at Pfizer's manufacturing sites in Belgium (in Puurs) and in the United States as well as by BioNTech in Marburg, Germany. The French company Delpharm based in Eure-et-Loir will also produce the Pfizer vaccine from April 2021.
→ The Moderna vaccine is manufactured in Visp in Switzerland than in Monts in Eure-et-Loir.
→ The AstraZeneca vaccine is notably produced by Novasep in Seneffe in Belgium and by the Dutch company Halix in Leiden, in the Netherlands. The vaccine is packaged in Italy in Agnini and in Spain.
→ Fareva is expected to produce the German vaccine CureVac (if it receives authorization from the European Medicines Agency) at its sites in Pau (Pyrénées-Atlantiques) and Val-de-Reuil (Eure) in May.
What vaccines have been ordered by France?
France, via the European Commission, has pre-purchased 200 million doses of anti-Covid vaccines from different laboratories (68 million should be available by July 1). Several contracts have been signed by the European Commission: with the pharmaceutical companies BioNTech-Pfizer, Moderna, the American Johnson & Johnson, AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, and the German CureVac. France should benefit from the same vaccines as the other countries of the European Union. "The number of doses being distributed according to the population of each member state" recalled the President of the Republic on November 24.
→ France has ordered 30 million doses of the Pfizer / BioNTech vaccine for deliveries until the fall of 2021. It should then receive 20 million doses until the end of the year, or 50 million in total.
→ France has pre-ordered 24 million doses of the Moderna vaccine expected in 2021.
→ France has pre-ordered 44 million doses of the AstraZeneca vaccine.
What are the Covid vaccines authorized in Europe?
Marketing Authorizations (AMM) are issued by the European Commission. In the context of the pandemic and the public health emergency, MAs are said to be conditional. As the ANSM explains, a conditional MA allows the authorization of drugs that meet an unmet medical need before long-term data on efficacy and safety are available. Conditional marketing authorization is granted for one year and can be renewed. When the European authorities have received and assessed all the additional data required, the conditional MA can be converted into a standard MA.
Vaccines authorized in Europe
The Comirnaty® Covid-19 mRNA vaccine is the first vaccine to be granted conditional marketing authorization (MA) in Europe on December 21, 2020.
The vaccine of the American Moderna (also with mRNA) is the second vaccine to have received the green light from the EMA on January 6, 2021. The High Authority of Health has not yet validated its marketing in France.
The vaccine from AstraZeneca and the University of Oxford (phase 3 clinical trials) based on viral vector technology was authorized on January 29, 2021.
Janssen J & J's vaccine (phase 3) also on viral vector technology authorized on March 11, 2021.
- The vaccine being analyzed by the EMA
- The Sputnik V vaccine
- The CureVac vaccine
- Vaccines not yet submitted to the EMA
- The Novavax vaccine
- The Sanofi-Pasteur vaccine
What are the different types of Covid vaccines?
Faced with a very contagious and deadly virus for the most vulnerable, several large drug companies and large biotechs or research centers have positioned themselves in the vaccine race. Many alliances have been formed. All of the phase 3 trials conducted relate to vaccines that are administered by the intramuscular route.