Pre-orders of vaccines and procedural matters European Union vaccine negotiations Bulgaria eventually agreed to purchase all seven
vaccines included in the European portfolio -
Moderna,
Pfizer-BioNTech,
Oxford–AstraZeneca,
Sanofi,
CureVac,
Novavax, and
Janssen, even though it had some reservations regarding its participation in the contract with
Janssen Pharmaceutica. On 14 October 2020 Bulgaria explicitly refused to pre-order the latter's vaccine candidate as part of the EU-wide deal, but reversed course in November and ratified a separate agreement for 2 million doses in December, aided by
Sweden's cooperation, After major delays due to trial issues of Sanofi and GlaxoSmithKline's vaccine candidate, for 2021 the country was in the initial months mostly reliant on the Oxford–AstraZeneca COVID-19 vaccine, expecting to receive enough doses for vaccinating 2.5 million citizens. After at first ordering 1 million doses from Pfizer-BioNTech, on 13 January 2021 when the
European Commission announced that it had concluded an agreement for extra 300 million doses with this vaccine producer, Bulgaria requested additional 2.9 million Pfizer-BioNTech vaccines, with a later agreement resulting in the quantity of pre-ordered doses of this vaccine for 2021 rising to 5.4 million. In total, the amount of vaccine pre-ordered or set to be ordered by the country is expected to be equivalent to 18 million doses, able to cover 9 million citizens. In May 2021, Bulgaria made a pre-order for 14 million Pfizer vaccine doses for 2022 and 2023, with 8,354,768 expected for the latter year. In August 2021, it was revealed that Bulgaria had pre-ordered a new type of attenuated vaccine, developed by Valneva Austria. In September 2021, it was confirmed that Bulgaria will buy only 10,000 out of the pre-arranged doses from the one-shot Sanofi Pasteur SA/Glaxosmithkline Biologicals SA vaccine, which are to be delivered in 2022. In August 2023, it was confirmed that Bulgaria will receive 1,3 million doses from the adapted Pfizer-BioNTech vaccine, which targets the XBB.1.5 Omicron variant.
Vaccine availability issues, further deals and new approach to the ordering of vaccines On 25 February 2021, then Health Minister Kostadin Angelov publicly reproached
AstraZeneca after it became clear that the pharmaceutical company will be able to provide 40% of the promised vaccines by August. Bulgaria had also offered to assist with the delivery of the next batch of vaccines by sending its own airplane, but this suggestion had not been accepted. On the next day it was revealed that there is an alternative plan, which will entail receiving an extra 1 million Pfizer-BioNtech and 480 000 Moderna doses between March and June. On 28 February 2021, Boyko Borisov confirmed that Bulgaria had entered talks to borrow vaccines from EU countries where there is no queuing for them, so that Bulgaria does not have to halt its vaccination process. On 1 March 2021, it was disclosed that Bulgaria had arranged for over 450 000 additional doses of the Moderna vaccine, as a result of a direct agreement with Sweden. In early March 2021, Bulgaria and five other EU countries (Slovenia, Croatia, Austria, Czech Republic, and Latvia) insisted that a new debate is initiated regarding the allocation of the vaccines within the EU bloc, with Boyko Borisov echoing Austrian Chancellor
Sebastian Kurz's sentiment that some EU states had received more vaccines than warranted by their population numbers. On 13 March 2021, the European Commission sent out statement clarifying that some member states, with Bulgaria being implied to be among them, had on their own accord deviated from the principle of pro rata allocation during the initial placing of orders for vaccines, freeing up additional doses for other countries. Bulgaria is believed to have refrained from exercising its option of ordering 30 million doses in total. On 26 March 2021,
Croatian Prime Minister Andrej Plenković stated that Bulgaria should receive the most relative to the other countries out of the 10 million doses of Pfizer-BioNTech vaccines that will arrive in the second quarter of the year, earlier than scheduled, as a compensation for the production issues faced by AstraZeneca. Even though Austria (that led the redistribution campaign), Slovenia and the Czech Republic rejected the eventual proposal that was arrived at, in early April 2021, it was confirmed that Bulgaria (alongside Croatia, Slovakia, Latvia, and Estonia) will in addition to getting its pro rata allocation, also benefit from the sharing of 2.85 million "solidarity vaccines" (out of the 10 million doses) among these five countries. In May 2022, the Ministry of Health sent out a letter to the European Commission, emphasizing that while it remains committed to securing a wide range of vaccines for Bulgarian citizens, it believes that there should be a high degree of flexibility regarding the amount of vaccines bought, in accordance with the needs of the population in order not to have another scenario with an excess of vaccines. In early 2023, the health authorities confirmed that Bulgaria is in favor of cancelling the European Commission's contract with Pfizer/BioNTech or would support an approach to the ordering of vaccines where the deliveries reflect the specific requests of each country. Bulgaria's position regarding the potential issues surrounding an excess of vaccines has been seen as being in alignment with that of Poland as well as six other EU member states. After a new agreement was eventually reached between the European Commission and Pfizer-BioNTech in May 2023, it was revealed that Bulgaria would only receive the already paid for and postponed (in terms of delivery) quantities of vaccines for the year 2022, with no new vaccines to be delivered to the country until 2026 when the contract with the pharmaceutical company comes to an end, unless explicitly requested by Bulgarian authorities, in accordance with the Bulgarian citizens' needs. Bulgaria will still have guaranteed priority access to newly adapted Pfizer-BioNTech vaccines offering protection against novel COVID-19 strains over the course of the next three years.
Other vaccines According to Todor Kantardzhiev, one of the members of the National Operational Headquarters for the fight against the coronavirus, in 2021 Bulgaria did not rule out the purchase of vaccines from companies with which the European Commission had not negotiated contracts, such as
Sputnik and the
Sinopharm BIBP vaccine, as long as EU regulations were observed and especially if there was a delay regarding the delivery of the other vaccines. On 26 February 2021, the opposition
BSP party demanded that the government begin separate talks with
Russia for the importation of the Sputnik vaccine. The Health Commission of the
National Parliament initially rejected the proposal, but on 28 April 2021 accepted BSP's demands. However, even though
ITN,
Stand Up! Mafia, Get Out! and one deputy from
Democratic Bulgaria joined forces with BSP during the vote on 7 May 2021, the proposal still did not pass the required threshold in the National Parliament, which would have empowered the Council of Ministers to take all necessary measures to secure access to Sputnik. Ethnic Bulgarians have been administered the Sputnik vaccine in Russia. Microbiologist
Andrey Chorbanov has pointed out that the country already imports medications that are not regulated by the EU, so the thinking should not be different when it comes to the Russian vaccine. The importing of vaccines from third countries was also supported by the
RzB party, even if the EU is bypassed and only the Bulgarian Drug Agency approved them. Some journalists noted that Bulgaria recognized the vaccinations of foreign citizens with Sputnik as well as with the Sinopharm BIBP vaccine and
CoronaVac as one of the conditions for entry into the country. A COVID-19 vaccine based on
nanoparticles is presently under development by the
BAS, with completed preclinical research, but despite receiving financial support from the
Pasteur Institute, issues related to funding are expected to significantly slow down the progress when it comes to the
vaccine trials. It was unveiled to the wider public at the 15th World Congress of Vaccines held online in October 2021.
Approved vaccines Kostadin Angelov, the former Minister of Health, has on a number of occasions reiterated that Bulgarians should be able to have a choice regarding the type of vaccine they are to receive. Five vaccines are currently available for use in Bulgaria. The first to be administered in the country was
Pfizer–BioNTech, which was approved by the
European Commission on 21 December 2020, on the same day after receiving recommendation for granting conditional marketing authorization by the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA), with the initial doses delivered to Bulgaria 26 December, On 6 January 2021, following the same regulatory procedure,
the Moderna vaccine was also given the green light by the European Commission, arriving in Bulgaria a week later. On 29 January 2021,
Oxford–AstraZeneca vaccine received conditional authorization by the European Commission, paving the way for its use in EU countries. On the same date, Kostadin Angelov stated in an interview with
Boyko Vasilev during the TV show
Panorama that Bulgaria will wait for the results of further studies regarding its effectiveness when it comes to people over the age of 65 before administering it to members of this age group. The government eventually concluded that the vaccine is useful for elderly citizens as well and did not exclude them from receiving it. The first batch of this vaccine reached Bulgaria on 6 February 2021. On 11 March 2021, the one-shot
Janssen vaccine (Johnson & Johnson) became the fourth vaccine to be conditionally approved on the EU level, arriving in Bulgaria slightly over a month later. On 28 May 2021,
EMA approved the administering of the
Pfizer–BioNTech vaccine to children in the age range from 12 to 15. On 23 July 2021, the same agency gave the green light for the use of
the Moderna vaccine in children aged from 12 to 17. On 4 October 2021,
EMA recommended an
extra dose, using either
Pfizer–BioNTech or
Moderna, for people aged 12 or above whose immune system is severely weakened, to be administered at least 28 days after the second injection. It also stated that such a booster dose may be considered, with Pfizer–BioNTech, for all other people aged 18 or over at least six months after the second shot. On 25 October 2021, the same agency also approved the administering of a booster dose with Moderna for all adults. In November 2021, the Ministry of Health revealed that no deliveries of AstraZeneca had been made to Bulgaria since August 2021. However, in January 2022, 4800 new doses of AstraZeneca arrived in Bulgaria in response to specific demand for this vaccine. On 25 November 2021, the
Pfizer–BioNTech became the first COVID-19 vaccine in the EU to be approved for children below the age of 12, with the first pediatric doses arriving in Bulgaria on 20 December 2021. On 15 December 2021,
EMA approved the use of the Janssen vaccine as a booster. On 10 January 2022, Bulgaria followed suit in giving the nod to such an application of this vaccine. It can be administered two months after full vaccination (one dose) with the same vaccine and three months after a two-dose vaccination regimen with Pfizer–BioNTech or Moderna. On 20 December 2021,
Novavax joined the list of vaccines that can be used in the EU after receiving approval from EMA. Bulgarian health authorities confirmed that the country is yet to order doses from Novavax due to the country having an excess of vaccines. In January 2022, Health Minister Assena Serbezova stated that Bulgaria is looking at the option of obtaining Novavax vaccine doses from Sweden. On 24 February 2022,
Moderna was endorsed by
EMA regarding its use in children aged from 6 to 11 years old and on 2 March 2022 the European Commission followed suit in approving the vaccine for children in this age cohort. Bulgarian health authorities gave it the green light for use in children in this age group from 11 March 2022. On 23 June 2022,
the Valneva vaccine was authorized by EMA (as well as by the European Commission on the next day), to be used as a primary vaccination for people from 18 to 50 years old, arriving in Bulgaria in late October 2022. On 10 November 2022,
VidPrevtyn Beta received EMA's and the European Commission's authorization, with the caveat that it is to be used as a booster following a primary vaccination course with a mRNA or adenoviral vaccine, becoming available in Bulgaria in January 2023. On 30 August 2023, EMA approved the Pfizer–BioNTech Omicron XBB.1.5 vaccine. On 14 September 2023, the regulatory agency also provided an authorization to the Moderna vaccine, which targets the XBB.1.5 Omicron variant. 80 640 doses of this vaccine arrived in Bulgaria a week later, with the starting date for them being administered envisioned to be 27 September 2023.
Donated, sold and discarded vaccines Towards the end of May 2021, Bulgaria confirmed that 50,000 AstraZeneca Oxford-AstraZeneca doses will be given to
North Macedonia. With the supply of vaccines outstripping demand during the summer months, in July 2021 Bulgaria donated 172,500 doses of its AstraZeneca vaccines that were close to their expiration date to
Bhutan. In August 2021, 50,000 doses of the same vaccine were given to
Bosnia and Herzegovina as a donation while an agreement was reached with North Macedonia for the provision of 51,480 doses of the Pfizer–BioNTech vaccines as well as with Bhutan for another 172,500 AstraZeneca shots. During the same month, approximately 100,000 Moderna doses were resold to
Norway and the country was also in the process of reselling 546,000 Pfizer-BioNTech vaccines to
Portugal. The country subsequently donated 258,570 Pfizer-BioNTech doses to Bosnia and Herzegovina as well as 2,830,400 AstraZeneca vaccines to
Iran. In January 2023, it was revealed that Bulgaria had also been in touch with
Poland,
Sri Lanka and
Maldives regarding the possibility of vaccine donations, but had only received an affirmative response from the Maldivian side. As of October 2021, 184,089 AstraZeneca, 12,955 Moderna, 4500 Pfizer and 199 Janssen vaccine doses had been discarded due to reaching their expiration dates and no option for using them. As of August 2022, due to the low vaccine uptake, over 1,3 million vaccine doses had been declared unusable, with 1,6 million expected to have the same fate by the end of the year. By December 2022, the number of discarded or expected to be discarded vaccines exceeded 2 million. == Rollout schedule and vaccine priority groups ==