Here are the reliable vaccines against coronavirus approved in Hungary

When the coronavirus epidemic broke out in the spring, medicine began almost immediately, and research to develop a vaccine against the virus began to stimulate. In general, it is believed that it will take 10 years to develop an effective and safe vaccine. The fact that a licensed vaccine could have been produced 10 months after the genetic code of the coronavirus was known in January, the success of new technologies, the unprecedented efforts of pharmaceutical and biotech companies, significant financial resources, partly in the form of state aid, and the acceleration of authorization processes; it was due.

Authorized vaccines against coronavirus

There are currently 78 coronavirus vaccines in the human clinical trial phase and there are 11 vaccines in the world that have already been approved in at least one country under accelerated procedures.

• Pfizer / BioNTech vaccine in 55 countries
• Moderna vaccine is available in 37 countries
• Russian Sputnik V vaccine is available in 14 countries
• AstraZeneca / Oxford vaccine is available in 11 countries
• Chinese Sinopharm BBIBP-CorV vaccine in 8 countries
• The Chinese Sinovan Coronavac vaccine in 5 countries
• Indian Covidshield vaccine is available in 4 countries
• The Chinese Sinopharm and the Wuhan Biological Institute have a joint vaccine in 2 countries
• EpicVac Russian crown in 1 country
• Chinese CanSino vaccine in 1 country
• So far, the Indian Bharat Biotech Covaxin vaccine has been approved in 1 country.

The pharmaceutical authorities of each country issue authorizations for vaccines that have been shown in clinical trials to be safe and effective against the disease in question.

The process is generally carried out in such a way that the vaccine / drug development company, in light of the results of the clinical trials, submits the application to the pharmacovigilance authority of each country, where a decision is made on the authorization after detailed examination. Clinical trials have several phases, preclinical trials are conducted in animals, phase 1/2 clinical trials in humans are conducted in small groups, and phase 3 trials are large sample trials involving tens of thousands of persons.

Approving a vaccine in one country does not mean a global authorization, in each country where the vaccine is to be used, a separate permit is required from local authorities. Except, for example, in the EU, where the license of the European Medicines Agency automatically applies to all EU countries. However, individual member states can also use vaccines that are not approved by the EU at the local level, if the local authority, in Hungary, the National Institute of Pharmacy and Food Health (OGYÉI), approves them.

Vaccines authorized in Hungary

There are currently 5 licensed vaccines in Hungary, three, Pfizer, Moderna and AstraZeneca, have been approved by the EU, and two more have been approved by OGYÉI at the moment.

In late 2020, the European Medicines Agency approved the first vaccine, the Pfizer vaccine. On December 26, 2020, the first shipment of vaccines arrived in Hungary and vaccination of healthcare workers was able to begin. On January 6, the Moderna vaccine also received a European marketing authorization. The next vaccine, approved by the EU on January 29, is a vaccine jointly developed by AstraZeneca and the University of Oxford that has been vaccinated in the UK for weeks.

So far, OGYÉI has approved two vaccines in Hungary, which have not yet been approved by the EU (the Russian Sputnik V vaccine and the Chinese Sinopharm). Therefore, depending on deliveries, five types of vaccines will soon be available in Hungary. We present them to you now.

Vaccina Pfizer / BioNTech

The vaccine developed jointly by Pfizer and BionTech, called Comirnaty, was the first to be licensed in a Western country, the first in the United States.

The vaccine from the American pharmaceutical company and the German biotechnology company is a third-generation vaccine based on a new technology, called MRNA vaccine. The technology works by administering the mRNA vaccine with lipid nanoparticles into the body, which, after ingestion, causes the viral protein to increase with our cells, thus creating immunity. While conventional vaccines contain inactivated or killed virus or virus particles to elicit an immune response, the mRNA vaccine sends a message to the cells of the body instructing them to form the spike protein. The production of spike protein by cells triggers an immune response in the body, whereby the production of the antibody in the body begins.

Phase 3 clinical trials of 44,000 people on the vaccine measured 95 percent efficacy, while in Israel, where the population is mass vaccinated with the Pfizer vaccine (52 percent have already received at least one vaccine). An efficiency of 92 percent was measured.

Comirnaty was licensed in the United States in early December and the EU also authorized its emergency use in late December. Vaccination with the Pfizer vaccine started in Hungary at the end of December and a total of 7 shipments have been received so far. The Pfizer / BioNTech vaccine must be administered in two doses, one of the disadvantages of which is the special storage requirement as it must be stored at -70 degrees.

Modern vaccine

The second Western vaccine to be licensed in the United States and later in Europe was the Modern American vaccine.

Like the Pfizer vaccine, the Moderna vaccine is a MRNA vaccine. The vaccine formulation, called mRNA-1273, has been tested in more than 30,000 people. The vaccine is administered in two doses, 28 days apart, based on the results of phase 3 clinical trials. provided 94 percent protection against covid disease for the entire study population. It provided 100 percent protection against serious illness.

Moderna’s vaccine received a license from the European Medicines Agency in January, a shipment has so far arrived in Hungary, but it has a smaller production capacity than Pfizer and promised to deliver fewer doses this year. In the case of the Moderna vaccine, the lipid nanotechnology used as a “package” is slightly more favorable for storage than Pfizer, so it can be stored at higher temperatures, -20 degrees Celsius, for 6 months, which significantly simplifies logistics.

AstraZeneca / Oxford vaccine

The British vaccine, jointly developed by AstraZeneca and the University of Oxford, is also a representative of modern vaccine technologies, but it is not an mRNA vaccine, but one of the so-called vector vaccine. The essence of the technology is to introduce the gene that encodes the coronavirus spike protein by inserting it into a modified virus that does not replicate (in this case, a chimpanzee adenovirus). Our immune system also acts and protects against the virus (vector) that delivers the gene that encodes the coronavirus spike protein.

Based on the results of more than 30,000 volunteers from phase 3 clinical trials the vaccine is 70 percent effective on average (The effectiveness was 62 and 90 percent with different application methods.)

At the end of December, the vaccine was licensed in the UK, so vaccination has already started there and was approved by the EU on January 29. In Hungary, the AstraZeneca vaccine received a license from OGYÉI along with the Russian Sputnik V vaccine made with similar technology prior to the EU license in late January. The vaccine can be stored, transported and handled under normal refrigeration conditions (2-8 C) for at least 6 months after manufacture. This is important due to the availability of vaccines in countries that are more difficult to access or do not have a good infrastructure.

Sputnik V vaccine

The Sputnik V vaccine is the first Russian coronavirus vaccine to be used to vaccinate front-line workers in Russia since August – about 800,000 people so far, according to Bloomberg.

Sputnik V vaccine is also based on modern technology vector vaccine. Developed by the Russian Institute Gamaleya (National Center for Epidemiology and Microbiology of Gamaleya), two different human adenovirus vectors (Ad5 and Ad26) are used in two doses of the vaccine. Because it is important for the effectiveness of vector vaccines to have a virus that the vaccinated person probably has not encountered before, otherwise the vaccine will not be effective, so they will surely use both types of viruses.

The results of the phase 1/2 studies were published in the renowned medical journal The Lancet, and show that the vaccine elicited a safe and strong immune response. The improvements have been harshly criticized by many, as phase 3 clinical trials were still underway when the vaccination program in the country had already started. The largest Russian randomized, double-blind, placebo-controlled trials involving 40,000 people began in September 2020 and are expected to have final results by May 1, according to the official registry. Kirill Dmitriev, executive director of Russia’s direct investment fund, which manages the international marketing of the vaccine, previously said that the results of the third clinical phase of the Russian vaccine could be published in a major international medical journal this week. For large sample testing, one in advance 91.4 percent efficiency The development institute released the number after vaccinating more than 22,000 people.

In Hungary, it received the OGYÉI license last week along with the AstraZeneca vaccine made with similar technology. Sputnik V vaccine storage conditions are simpler than Pfizer’s, -18 degrees Celsius is enough to store and thaw in a normal refrigerator at 2-8 degrees.

Vaccina sinopharm

Two of China’s vaccine developments are at the forefront and have already been tested and used outside of China, one of them is Sinopharm.

Chinese state-owned Sinopharm is also developing two vaccines, both “Traditional” technology that uses an inactivated virus. The company announced in late December that Phase 3 tests would be conducted 79 percent efficient measured, while in the United Arab Emirates, where it was tested in 31,000 people, an efficacy of 86 percent was reported and no serious side effects were reported. Vaccination with the vaccine began months ago in China, and so far almost 1 million people receive it. In addition to China, Sinopharm has been licensed by the United Arab Emirates, Bahrain, Egypt, Iraq, Jordan, Seychelles, and Pakistan.

OGYÉI gave the green light to the Sinopharm vaccine in Hungary among Chinese vaccines, and the government has contracted enough vaccines to vaccinate 5 million, or 2.5 million people.

Cover Image: Oliver Bunic / Bloomberg via Getty Images