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Covid-19: Covaxin & Sputnik V – What do we know so far?

AstraZeneca,-Covaxin,-Sputnik

Mauritius received 200,000 doses of Covaxin from India, Friday 19th March, while 250,000 doses of Sputnik V are currently being negotiated. Sputnik V however is yet to be approved by the WHO. Both of these vaccines were approved by the National Vaccination Committee alongside AstraZeneca’s vaccine.

200,000 of India’s homegrown vaccine, the Covaxin, arrived in Mauritius, Friday 19th  March. The Covaxin, was developed by Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). The preliminary data from its phase 3 trials shows that the indian vaccine has an efficacy of 81%. 

On the 3rd of March 2021, Bharat Biotech announced the first interim analysis of the Covaxin and said that the latest finding is “an important milestone in vaccine discovery, for science and our fight against coronavirus”. 

“With today’s results from our Phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants. COVAXIN demonstrates a high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants,” said Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech

The trial involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research.

The Covaxin contains a whole virion inactivated SARS-CoV-2 vaccine, which is produced in Vero cells. It is stable at 2 to 8°C (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels. BBV152 also known as Covaxin has a 28-day open vial policy as a unique product characteristic, thus reducing vaccine wastage by approximately 10-30%.

How does the Covaxin work?

Covaxin is an inactivated vaccine, which ensures it contains killed coronaviruses and is thus safe to administer into the bloodstream. Bharat Biotech used a coronavirus sample isolated by India’s National Institute of Virology.

Immune cells will still recognize the dead virus when it is delivered, causing the immune system to produce antibodies against the covid-19 virus.

The Covaxin comes with two dosages and it is given with an interval of 28 days. It can be stored at 2 to 8 degree celsius. 

As for side effects, the factsheet of the vaccine indicates it may cause pain at the injection site, swelling of the injection site as well as redness and itching. Other side effects consist of stiffness in the upper arm, weakness in the injection arm, body ache, headache, fever, malaise, weakness, rashes, nausea and vomiting. 

There is also a remote chance that the vaccine could cause a severe allergic reaction.  The signs of a severe allergic reaction can include, difficulty in breathing, swelling of the face and throat, a fast heart beat, rash all over the body, as well as dizziness and weakness. 

The controversy around the Covaxin

Approved on the 4th January, while its phase 3 was still ongoing, the Covaxin was highly doubted and questioned by experts. Back then, Bharat Biotech maintained that the clinical trial was following the guidelines even though data was not published. As for the regulator, it explained that the vaccine was safe and had given its approval with belief that it could be more effective in containing the UK variant of the coronavirus. 

The All India Drug Action Network said that it was “baffled to understand the scientific logic” to approve “an incompletely studied vaccine”. It said that there were “intense concerns arising from the absence of the efficacy data”. 

Both the regulator and the manufacturer defended the vaccine back then and Bharat Biotech explained that the Indian clinical trial laws allowed “accelerated” authorisation for use of drugs after the second phase of the trials for “unmet medical needs of serious and life-threatening diseases in the country”. Bharat Biotech had also promised to provide the efficacy data of the vaccine by February, which the manufacturer did. 

Sputnik V (Gamaleya) 

The russian vaccine, Sputnik V was approved by the National Vaccination Committee on the 19th of February, said Kailesh Jagutpal. He added that an order for 250,000 doses were placed. 

However, the Leader of the Opposition and the PMSD (Parti mauricien social-démocrate), Xavier Luc Duval argued that the Minister of Health is changing its course of action and that he was due to give an explanation. “From the start, Minister Jagutpal has said he will not pre-order Covid-19 vaccines without the endorsement of the World Health Organization (WHO). Now it’s a ‘complete U-Turn’. He has publicly announced that he is ordering these Russian vaccines, which have not yet been approved by WHO. It’s serious. ‘Nou pa kapav ena de pwa de mezir’. We must demand explanations from Dr Jagutpal on this subject (…) ” said Xavier Luc Duval 

The Sputnik V, indeed has not yet been approved by the WHO, but the Emergency Medicines Agency (EMA) started its rolling review on the 4th of March. Around 40 countries already approved the vaccine for emergency use, namely Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia, Armenia, Mexico, Nicaragua, Republika Srpska (entity of Bosnia and Herzegovina), Lebanon, Myanmar, Pakistan, Mongolia, Bahrain, Montenegro, Saint Vincent and the Grenadines, Kazakhstan, Uzbekistan, Gabon, San-Marino, Ghana, Syria, Kyrgyzstan, Guyana, Egypt, Honduras, Guatemala and Moldova. 

The Sputnik V, developed by the Gamaleya Research Institute of Epidemiology and Microbiology, is the world’s first registered vaccine based on a well-studied human adenoviral vector-based platform. Registered in various countries, the vaccine has an ongoing post-registration clinical trial in Russia involving more than 31,000 volunteers.  Phase 3 clinical trials of Sputnik V have been conducted in the UAE, India, Venezuela and Belarus.

The russian vaccine, is one of the three vaccines in the world with efficacy of over 90%. The Sputnik V vaccine confirmed its efficacy at 91.6% based on the analysis of data on 19,866 volunteers who received both the first and second doses of the Sputnik V vaccine or placebo at the final control point of 78 confirmed covid-19 cases. 

Similar to the Covaxin by Bharat Biotech, Sputnik V initially met with some controversies after being rolled out before the final trial data had been released. However, scientists are now more convinced as the benefits have now been demonstrated. 

The Lancet, one of the oldest and best-respected medical journals, deemed the vaccine as “safe and effective” which earned the russian vaccine some trust from different countries despite the geopolitics that involves Russia and other countries. 

Professors Ian Jones and Polly Roy, authors of the paper titled “Sputnik V COVID-19 vaccine candidate appears safe and effective” published by the Lancet said: “The development of the Sputnik V vaccine has been criticised for unseemly haste, corner cutting, and an absence of transparency.”

“But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of Covid-19”.

They further pointed out that the vaccine had a good effect in all age groups and reduced the seriousness of the disease after one dose. The authors also added that the analysis only included symptomatic cases of covid-19 and more work would be needed to understand whether it stops even asymptomatic cases and prevents the virus from being passed on by people who’ve been vaccinated.

How does the Sputnik V work?

Two different doses, that is the unlikeliness of the russian vaccine. The Sputnik V vaccine uses two slightly different versions of the vaccine for the first and second dose which is given 21 days apart.

Both doses target the coronavirus’ distinctive “spike”, but use different vectors which is the neutralised virus that carries the spike to the body. The two different formulas boosts the immune system even more than when using the same version twice and this may also give longer lasting protection. 

As well as proving effective, it was also safe with no serious reactions linked to the vaccine during the trial. Some side effects to a vaccine are expected but these are usually mild, including a sore arm, tiredness and a bit of a temperature. And there were no deaths or serious illness in the vaccinated group linked to the jab.

Latest update about AstraZeneca’s vaccine

Following reports of blood coagulation in patients having received AstraZeneca’s vaccine, after which several countries suspended the vaccine.The Emergency Medicines Agency (EMA) was expected to give a response as to whether these cases of blood coagulation were linked to the vaccine on Thursday 18th of March. 

AstraZeneca Covid-19 Vaccine

The European Medicines Agency (EMA) confirmed on Thursday March 18 that AstraZeneca’s vaccine against Covid-19 was safe and effective after its suspension in several countries, including France, following suspected cases of adverse effects or even death.

“The committee came to a clear scientific conclusion: this is a safe and effective vaccine,” EMA Executive Director Emer Cooke said in a video conference.

“Its benefits in protecting people from Covid-19, with the associated risks of death and hospitalization, outweigh the possible risks,” added Emer Cooke.

The European regulator, based in Amsterdam, “also concluded that the vaccine was not associated with an increase in the overall risk of thromboembolic events or blood clots,” said the director.

Emer Cooke, however, explained that the EMA “cannot definitively exclude” a link between the vaccine developed by the Swedish-British laboratory AstraZeneca and rare bleeding disorders.

The EMA’s safety committee therefore recommended “to raise awareness of these potential risks and to ensure that they are included in the product information”.

She also advised “to draw attention to these possible rare diseases and to provide information to healthcare professionals and those vaccinated to help stop and lessen any possible side effects,” said Emer Cooke.

The EMA will also launch “additional investigations to find out more about these rare cases”, she added, saying however: “If it was me, I would get vaccinated tomorrow”.

Following this decision of the EMA, France confirmed that it will restart its vaccination campaign without any delay while Norway and Sweden announced that they will wait before a possible resumption of vaccination with the AstraZeneca product. 

The Nowegian Institute of Public Health explained that it had taken note of the EMA’s opinion but that it was “premature to conclude” and indicated that it would deliver its own opinion “at the end of next week”.

“Vaccination with AstraZeneca will remain on hold until we have a full picture of the situation,” said the Director of the Nowegian Institute of Public Health, Camilla Stoltenberg, at a press conference.

As for the other countries, they are yet to take a stand about the matter.