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CoviShield COVID-19 Vaccine

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October 25, 2021
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CoviShield COVID-19 Vaccine Description

The CoviShield COVID-19 (AZD1222) (C19VAZ) vaccine, formerly known as ChAdOx1 nCoV-19, is made from a virus (ChAdOx1), a weakened version of a common cold virus (adenovirus). In addition, genetic material has been added to the ChAdOx1 construct, which is used to make proteins from the SARS-CoV-2 coronavirus called Spike glycoprotein (S).

Drug regulators in India granted emergency approval for the coronavirus vaccine co-developed by AstraZeneca Plc and the University of Oxford on January 1, 2021. This vaccine is the same formulation as the Vaxzevria (AZD1222) vaccine.

On February 15, 2021, the World Health Organization (WHO) recommended the Serum Institute of India Pvt Ltd COVID-19 Vaccine (ChAdOx1-S [recombinant]) known as COVISHIELD. On March 19, 2021, the WHO confirmed that the AstraZeneca COVID-19 vaccine (Covishield) has a favorable benefit-risk profile, with tremendous potential to prevent infections and reduce deaths worldwide.

On April 23, 2021, the Centre for Cellular and Molecular Biology announced that CoviShield might protect people from various SARS-CoV-2 mutations.

SII's updated fact sheet for CoviShield. CoviShield is the Serum Institute of India version of the AstraZeneca COVID-19 vaccine. On June 4, 2021, a non-peer-reviewed study found 'CoviShield vaccinated healthcare workers could produce a high immune response in up to 95% of recipients and prevent serious disease in those infected after immunization.

AstraZeneca announced on June 15, 2021; Public Health England demonstrated COVID-19 Vaccine AstraZeneca offers high levels of protection against the Delta variant (B.1.617.2; formerly the 'Indian' variant). The Real-world data from PHE demonstrated two doses of COVID-19 Vaccine AstraZeneca are 92% effective against hospitalization due to the Delta variant and showed no deaths among those vaccinated. In addition, the vaccine also showed high effectiveness against the Alpha variant (B.1.1.7; formerly the 'Kent' variant) with an 86% reduction in hospitalizations and no deaths reported.

The NEJM published a Correspondence based on data from Scotland on October 20, 2021, that found that the ChAdOx1 nCoV-19 vaccine (CoviShield, AstraZeneca) offered substantial protection against death from Covid-19 caused by the delta variant. In addition, the Oxford-AstraZeneca vaccine was 91% effective in preventing deaths in people who have been double vaccinated but who have tested positive for coronavirus in the community, research shows.

Serum Institute of India Pvt. Ltd. is now the world's largest vaccine manufacturer by the number of doses produced and sold globally (more than 1.5 billion doses). The Poonawalla Bio-Tech Park at Manjari in Pune is a State-of-the-Art facility designed to meet the highest standards set by many regulatory agencies, including the MHRA, U.S. FDA, and Europe Japan, Australia, etc.

CoviShield COVID-19 Vaccine History

The WHO granted Emergency Use Listing to the AstraZeneca - Oxford COVID-19 vaccine 'COVISHIELD' ChAdOx1-S [recombinant] manufactured by Serum Institute of India on February 15, 2021. Click here to review the history of SII's CoviShield vaccine.

On April 20, 2021, the Canadian government published a FAQ for CoviShield. Canada affirmed that Canadians would continue to access AstraZeneca Vaxzevria (CoviShield) after September 16, 2021, while the submission is under review for transition to the Food and Drug Regulations.

On April 24, 2021, India's Union Health Secretary Shri Rajesh Bhushan and Dr. R S Sharma, Chairman, Empowered Group on Technology and Data Management to combat COVID-19, chaired a high-level meeting to guide the States/U.T.s on effective implementation of the New Vaccination Strategy (Phase-3) on May 1, 2021, and to review their augmentation plans to strengthen the existing hospital and clinical treatment infrastructure for COVID patients. 

Phase 2/3 clinical trial CTRI/2020/08/027170 was last updated on June 12, 2021. 

CoviShield is Listed by the Caribbean Regulatory System, the WHO, and the Africa Regulatory Taskforce

Covishield COVID-19 Vaccination While Pregnant or Breastfeeding

Pregnant women "can and should" be vaccinated against COVID-19, the India Union Health Ministry announced. "The Health Ministry has given guidelines that the vaccine can be given to pregnant women. Vaccination is useful for them and should be given," said Dr. Balram Bhargava, Director-General of the Indian Council for Medical Research, on June 25, 2021.

Covishield COVID-19 Vaccine For Children

On September 28, 2021, Indian media reported that Serum Institute was enrolling children aged 7-11 years for its COVID-19 vaccine trial.

CoviShield COVID-19 Vaccine Side Effects

A rare new type of adverse event called Thrombosis with Thrombocytopenia Syndrome, involving unusual and severe blood clotting events associated with low platelet counts, has been reported after vaccination with COVID-19 Vaccine Covishield, reported the WHO on April 16, 2021. On May 17, 2021, media reports indicated India's National Adverse Event Following Immunisation committee completed an in-depth case review of 498 serious and severe events, of which 26 cases have been reported to be potential thromboembolic following administration of Covishield vaccine, "with a reporting rate of 0.61 cases/ million doses".

On June 29, 2021, Health Canada updated the product monograph for COVISHIELD COVID-19 vaccines to add capillary leak syndrome as a potential side effect, with a warning for patients with a history of capillary leak syndrome to not get the AstraZeneca or COVISHIELD COVID-19 vaccine.

On September 8, 2021, the EMA published safety updates for the AstraZeneca vaccine. In addition, Canada posted an update for Rare vaccine side effects. Covishield's side effect information can be found here.

CoviShield COVID-19 Vaccine Ingredients

CoviShield ingredients can be found on this University of Oxford website.

CoviShield COVID-19 Vaccine News

October 22, 2021 - Local media reported Poland recognized Covishield now shares equal status with the other European Union approved vaccines.

October 18, 2021 -  Local media reported a study conducted by researchers from the Indian Council of Medical Research Regional Medical Centre and Institute of Virology, highlighted that mixing doses of the Covishield vaccine could provide a stronger, efficient response against the SARS-COV-2 virus.

October 13, 2021 - The Indian government is not changing the intervals between Covishield vaccine dosing, reported The Economic Times.

October 9, 2021 - Sagar Dahal, chief of the National Immunisation Programme in Nepal, confirmed to local media one million doses of Covishield arrived, part of the 2 million doses of the vaccine for which the government had paid Serum $4 per dose. 

October 7, 2021 - Local media reported the Union government of India permitted the export of 10 lakh doses each of Covishield to Nepal, Myanmar, and Bangladesh.

October 5, 2021 - International travelers who have been vaccinated with the Covishield vaccine will no longer be subject to the COVID-19 entry rules, the Norwegian Ministry of Health and Care Services announced, SchengenVisaInfo.com reports. '‘There is no longer a need for global travel advice. We will now go back to assessing countries on an individual basis to determine the need for travel advice.'

October 2, 2021 - The President of the U.N. General Assembly, Abdulla Shahid, confirmed he was vaccinated with the Covishield vaccine.

October 1, 2021 - Australian Prime Minister Scott Morrison stated in an online briefing the Therapeutic Goods Administration (TGA) has advised that the Covishield vaccine would be considered a "recognized vaccine" when determining whether an incoming international traveler has been appropriately vaccinated. On February 16, 2021, the TGA granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine.

September 27, 2021 - Italy's Ministry of Health confirmed the administration of "booster" doses of COVID-19 vaccine to subjects aged ≥ 80, elderly residential care centers, practitioners of the health professions, and health care, workers.

September 24, 2021 - The Indian Embassy in Rome announced the Italian Ministry of Health has decided to recognize the Covishield as valid proof of immunity.

September 22, 2021 - The BBC reported that the U.K. government clarified that the Covishield vaccine was approved.

September 17, 2021 - Local media reported Serum Institute of India (SII) Adar Poonawalla, CEO, said that his company had ramped up capacity to 160 million doses this month, which would go up to 200 million doses per month from October 2021.

September 15, 2021 - The EMA published Vaxzevria (previously COVID-19 Vaccine AstraZeneca, CoviShield) EPAR - Product information.

September 10, 2021 - India's Union government has placed a purchase order with the Serum Institute of India for 66 crore doses of Covishield to be supplied by December 2021.

August 31, 2021 - The WHO reported falsified COVISHIELD vaccine identified in the WHO regions of Africa and Southeast Asia.

August 31, 2021 - The Time of India reported a single dose of Covishield following a Covid-19 infection gives "hybrid immunity" that is more potent than two vaccinations or infection alone, shows a new study from Kerala, India.

August 26, 2021 - LocalCircles conducted a nationwide survey to understand better what (40,000) citizens in India experienced after 1st and 2nd dose of CoviShield. On an aggregate basis, 75% of Indians who took COVISHIELD 2nd dose experienced no or mild side effects; 4% reported COVID infection thereafter.

August 26, 2021 - Local media reported Serum Institute of India informed the Centre that it would supply around 20 crore doses of Covishield in September 2021. The company has already supplied 12 crore doses.

August 16, 2021 - The WHO issued a Medical Product Alert regarding falsified COVISHIELD (ChAdOx1 nCoV-19 Corona Virus Vaccines (Recombinant)) identified in the WHO African Region and the WHO South-East Asia Region. These falsified products have been reported at the patient level in Uganda and India.

August 14, 2021 - The Romanian Ministry of Health now accepts the CoviShield vaccine as valid proof of immunity for entry into its territory. 

August 7, 2021 - A non-peer-reviewed study in India suggests that immunization with a combination of an adenovirus vector platform-based vaccine followed by an inactivated whole virus vaccine was not only safe but also elicited better immunogenicity.

July 29, 2021 - Covishield has not been approved for use by EMA, but 15 E.U. countries have already recognized the vaccine after being added to the Emergency Use Listing by WHO.

July 28, 2021 - Covishield vaccine gives 93% protection against COVID-19 and reduces the mortality rate by 98%, according to a study done by the Armed Forces Medical College based in India.

July 26, 2021 - Local media reported foreign returnees, who have taken the first dose of Covid vaccine - Covishield or AstraZeneca outside the country and returned to Odisha, can take the second dose of Covishield as per schedule in the Indian State.

July 19, 2021 - Media reported French authorities have revealed that the country will now accept proof of vaccination with the AstraZeneca vaccine manufactured by the Serum Institute of India. France has now become the 14th E.U. Member State to allow entry for all travelers who have been immunized with the Covishield vaccine. Previously, France had only recognized Comirnaty, SpikeVax, Vaxzevria, and Janssen.

July 1, 2021 - Aljazeera reported nine countries in Europe to have told India they would accept travelers inoculated with Covishield, Indian foreign ministry sources.

July 1, 2021 - Media reports indicate Estonia, Austria, Germany, Slovenia, Greece, Iceland, Ireland, Switzerland, and Spain have confirmed accepting Covishield vaccinated travelers in the Green Passport.

June 28, 2021 - Local media reported Serum Institute of India has applied to the European Medicines Agency for the Covishield vaccine in the list of approved vaccines for the E.U.' Green Passport.'

June 28, 2021 - Serum Institute of India confirmed it produced over ten crore doses of Covishield in June 2021, reports Economic Times.

June 24, 2021 - Local media reported a single dose of the Covishield vaccine had been found sufficient to protect previously Covid-19 infected people who have attained immunity after recovering from the infection, revealed a study by researchers at the ICMR and the Assam Medical College, Dibrugarh.

May 31, 2021 - Reuters reported the Serum Institute of India would increase the CoviShield vaccine to about 90 million doses in June 2021 from about 65 million a month.

May 17, 2021 - The WHO Regional Office for Africa clarified the expiry dates of COVID-19 vaccines in general, specifically on AstraZeneca vaccine doses produced by the Serum Institute of India (Covishield) that were delivered to several African countries and have since expired.

May 13, 2021 - India's Centre accepted the Covid-19 Working Group's recommendation for extending the gap between the two doses of the Covishield. Based on a study published by The Lancet on February 19, 2021, the decision was taken that claimed a 26.2% increase - from 55.1% to 81.3% - if CoviShield vaccine doses were spaced 12 or more weeks apart.

May 12, 2021 - India's Brihanmumbai Municipal Corporation confirmed it would continue vaccinating the younger age group with the Covishield vaccine.

May 3, 2021 - "Had an excellent meeting with all our partners and stakeholders in the U.K. Meanwhile, pleased to state that Covishield's production is in full swing in Pune. I look forward to reviewing operations upon my return in a few days," CEO Adar Poonawalla wrote on Twitter. The company expects to increase its monthly production from about 65 million to about 100 million by June 2021.

May 3, 2021 - India's Ministry of Health and Family Welfare confirmed' 100% advance of Rs. 1732.50 cr (after TDS Rs. 1699.50 cr) was released to Serum Institute of India (SII) on 28.04.2021 for 11 crore doses of Covishield vaccine during May, June, and July and was received by them on 28.04.2021. As of date, against the last order of 10 crore doses for supplies of Covishield vaccine, 8.744 crore doses have been delivered till 03.05.2021. Under the Liberalised Pricing & Accelerated National COVID-19 Vaccination Strategy, Govt of India would continue to procure its share of 50% of the monthly Central Drugs Laboratory cleared vaccines & would continue to make it available to the State Govts totally free of cost as was being done earlier.'

April 24, 2021 - The Serum Institute of India issued a statement defending the previously announced pricing of the CovidShield COVID-19 vaccine at Rs 600 for private hospitals and Rs 400 for the government.

April 21, 2021 - The Serum Institute of India (SII) confirmed it 'welcomes the recent announcement made by the Government of India's Ministry of Health and Finance Ministry to accelerate India's vaccination drive. The promising directives will help scale up vaccine production and allow state governments, private hospitals, and vaccination centers to procure vaccines directly. In the future, 50% of our vaccine production capacities will be served to the Government of India's vaccination program, and the remaining 50% of the capacity will be for the State governments and private hospitals. Following the Government of India directives, SII announced the prices of the vaccine.

April 19, 2021 - Local media reported of a total of about 144 million doses that India has supplied to states and Union territories till April 18, 2021, nearly 127 million were Covishield doses, and 17 million doses were of the Covaxin vaccine, according to government data accessed by H.T. till late on Sunday.

April 16, 2021 - The WHO published a statement: 'Global Advisory Committee on Vaccine Safety review of the latest evidence of rare adverse blood coagulation events with AstraZeneca COVID-19 Vaccine (Vaxzevria and Covishield).' Based on the latest available data, the risk of TTS with Vaxzevria and Covishield vaccines appears to be very low. However, there may be a geographic variation in the risk of these rare adverse events. It is therefore important to evaluate potential cases of TTS in all countries. Countries are encouraged to review, report and investigate all cases of TTS following COVID-19 vaccinations.

April 14, 2021 - Health Canada announced 'AstraZeneca COVID‐19 Vaccine (manufactured by AstraZeneca) and COVISHIELD (manufactured by Serum Institute of India) are ChAdOx1-S recombinant vaccines developed by AstraZeneca and Oxford University. Health Canada has reviewed the manufacturing information for these vaccines and found them to be comparable.'

April 14, 2021 - The BBC published an article: Sputnik V, Covishield, Covaxin: What we know about India's Covid-19 vaccines.

April 13, 2021 - A non-peer-reviewed study assessed the humoral immune response after the first dose of two vaccines, Covishield and the BBV-152 (Covaxin), in healthcare workers. These researchers concluded, 'While both vaccines elicited immune response, seropositivity rates to anti-spike antibody were significantly higher in Covishield recipient than Covaxin after the first dose. The ongoing COVAT study will further enlighten the immune response between two vaccines after the second dose.'

April 1, 2021 - The Serum Institute of India is reported to increase its output of CoviShield vaccines by 67% to 100 million doses a month beginning May 2021, up from 60 million doses a month currently.

The Drug Controller General of India has allowed the CoviShield - AstraZeneca vaccine's expiration time period from the earlier prescribed to nine months on March 31, 2021.

On March 13, 2021, AFP reported, '"We are looking at all the adverse events, severe adverse events like deaths and hospitalization. We will come back if we find anything of concern," said N.K. Arora, a member of India's national task force on COVID-19.' Serum Institute of India joined with AstraZeneca to produce 1 billion doses of its COVID-19 vaccine.

The India Ministry of Health and Family Welfare announced on March 22, 2021, 'Given the emerging scientific evidence, the interval between two doses of COVISHIELD, has been revisited by National Technical Advisory Group on Immunization and subsequently by National Expert Group on Vaccine Administration for COVID-19 in its 20th meeting. During this meeting, the recommendation has been revised to provide a 2nd dose of COVISHIELD at 4-8 weeks' interval after the 1st dose, instead of an earlier practiced interval of 4-6 weeks.'

March 1, 2021 - The governments of Côte d'Ivoire and Ghana began COVID-19 vaccination campaigns to protect healthcare workers.

On February 1, 2021, Pakistan's Dr. Faisal Sultan said to local media: "Though AstraZeneca's CoviShield is being prepared in India, it will come through Covax, an international alliance that has announced free vaccines for 20% of Pakistan's population. The Drug Regulatory Authority of Pakistan has already registered AstraZeneca."

To enable and support the country's response in fighting the COVID-19 pandemic, South Africa's SAHPRA had, on January 22, 2021, granted a Section 21 authorization to the Department of Health for COVISHIELD (a covid-19 vaccine manufactured by Serum Institute of India) for the prevention of COVID-19.

On January 19, 2021, India announced it granted Bhutan, Maldives, Bangladesh, Nepal, Myanmar, and Seychelles by distributing CoviShield vaccines beginning January 20, 2021. In Sri Lanka, Afghanistan, and Mauritius, India is awaiting regulatory clearances.

CoviShield COVID-19 Vaccine Storage Requirements

The vaccine can be stored, transported, and handled at normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least 6-months and administered within existing healthcare settings.

Clinical Trials

No clinical trials found