Bloomberg reported that Norway doctors have started investigating the deaths of 23 people who died shortly after receiving the Pfizer-BioNTech vaccine against coronavirus. Doctors said that people aged over 80 years, who have a weak body, are showing adverse reactions to the vaccine.

More than 25,000 people have been vaccinated in the Scandinavian country since the drive began on December 27, 2020.

A direct connection between the Pfizer vaccine and these deaths is yet to be established, but experts observed that 13 of the 23 people who have died have shown common symptoms of mRNA vaccines such as diarrhea, nausea and fever.

The Norwegian Institute of Public Health has cautioned against vaccinating elderly people above 80years of age saying those with a short life span may not benefit much from the jab.

Pfizer and BioNTech are working with the Norwegian authorities to investigate the deaths in Norway. According to Pfizer, the regulator discovered “the number of incidents so far is not alarming and in line with expectations”.

Experts cautioned that doctors need to be more careful in vaccinating people in the wake of the deaths of 23 elderly people.

Apart from Pfizer-BioNTech’s vaccine, the vaccine candidate by Moderna also uses mRNA platform. These are “coated molecules of mRNA, similar to DNA (Deoxyribonucleic acid), that carry the instructions for making a viral protein.

Meanwhile, many news reports said that Pfizer has now gone to temporarily reduce its vaccine supply in Europe following the concerns raised with the deaths in Norway.

The reduction in deliveries is due to Pfizer limiting output so that it can upgrade production capacity to 2 billion vaccine doses per year from 1.3 billion currently, the Norwegian Institute of Public Health (FHI) said.

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Prime Minister Narendra Modi will launch the pan-India inoculation of Covid-19 vaccine on Saturday at 10.30 am through video conferencing.

The coronavirus vaccination drive, one of the world’s largest vaccination programme, begins weeks after the DCGI approved Oxford coronvirus vaccine ‘Covishield’ manufactured by Pune-based Serum Institute, and indigenously developed ‘Covaxin’ of Bharat Biotech for restricted emergency use in the country.

In India, priority groups who are more exposed to the Covid-19 infection and are likely in the high-risk zone would be vaccinated first. Healthcare workers, both in the government and private sectors, including Integrated Child Development Services (ICDS) workers, will receive the vaccine during this phase. Adequate doses of both Covishield and Covaxin have already been delivered to all states/UTs with the active support of the Ministry of Civil Aviation.

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The UAE Ministry of Health and Prevention (MoHAP) has dismissed as false the rumours circulated across social media platforms about COVID-19 vaccines. Those spreading fake information will be held legally accountable, it warned.

MoHAP, in a statement, underlined the importance of obtaining information from official and reliable sources, and called upon all community members to verify the information before circulating them and avoid legal liability.

According to a tweet posted on the UAE Public Prosecution’s official handle last November, those spreading false information about products in the UAE will be slapped fines not less than Dh100,000 and not exceeding Dh500,000 or temporary imprisonment or either of the two.

The National Emergency Crisis and Disaster Management Authority (NCEMA) advised the public about the importance of getting vaccinated, given the new mutations of the coronavirus that is more dangerous.

On January 13, MoHAP announced that 118,928 doses of the COVID-19 vaccine were given in the past 24 hours. The total number of doses provided so far stands at 1,394,580.

Among the dignitaries receiving the first jab of the COVID-19 vaccine H.H. Sheikh Mohammed bin Hamad bin Mohammed Al Sharqi, Crown Prince of Fujairah.

The Ministry is currently working to increase the operational capacity in government and private health facilities and add more facilities to receive and accommodate the increasing numbers of community members willing to take the vaccine. Those wishing to take the vaccine do not have to book prior appointments; instead they can go directly to centres, hospitals and councils offering the vaccine.

The Sinopharm CNBG COVID-19 vaccine will also be administered within select SEHA facilities, including 35 Ambulatory Health Services (AHS) facilities in Abu Dhabi and Al Ain, 6 hospitals in the Al Dhafra region, Al Ain and Al Dhafra, SEHA’s National Screening Centre in Mina Rashid and Khawaneej in Dubai city, and existing screening centres in industrial areas, with an overall capacity of 150,000.

The COVID-19 vaccination centres, located in Abu Dhabi Cruise Terminal in Abu Dhabi City and Al Ain Convention Centre in Al Ain City, have a collective capacity to administer vaccine shots to 6,000 people daily and were established in a record four days. Vaccination aspirants will first register and then undergo a vital check-up, including blood pressure, height, weight, and temperature. Women will have to take a pregnancy test.

This will be followed by an assessment to confirm eligibility and signing a consent form. Thereafter, the first dose will be given. The appointment for the second dose, to be administered three to four weeks later, will come soon after.

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For private buyers, Covishield will be sold to at a higher price of Rs.1000 per dose.

Adar Poonawalla said that the first 100 million doses of the Covid-19 vaccine are being sold to the Indian government at a “special price” of Rs 200 per dose, after which prices would be higher.

The Indian government gave emergency authorisation to the Oxford University-AstraZeneca, but on the condition that SII doesn’t export the shots to ensure that vulnerable populations in India are protected.

He said that the company also has been barred from selling the vaccine on the private market. “We can only give (the vaccines) to the government of India at the moment,” Adar Poonawalla said.

Adar Poonawalla added that the Serum Institute was in the process of signing a larger contract with Covax for 300 million-400 million doses of the vaccine.

Covax is an initiative created to ensure equitable access to Covid-19 vaccines set up by the World Health Organization, vaccines alliance GAVI and CEPI, a global coalition to fight epidemics.

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The Pfizer-BioNTech Covid-19 vaccine has become the first vaccine to receive WHO validation for emergency use. This means the poorer countries may get access to the shots soon.

Every country that has a drug regulatory agency will have to issue its own approval for any coronavirus vaccine, but countries with weak health care systems usually rely on WHO to vet the shots.

The WHO said the decision to issue its first emergency use validation for a coronavirus vaccine “opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine.”

It also said its review found the Pfizer-BioNTech vaccine, which has already received clearance in the United States, Britain, the European Union and a dozen other countries, “met the must-have criteria for safety and efficacy set out by WHO”.

BioNTech-Pfizer’s coronavirus vaccine’s requirement to be stored at ultra-frozen temperatures is a big hurdle for developing countries where the required freezers and reliable electricity supply may not be available.

The coronavirus vaccine by Pfizer, which is based on a novel technology that uses synthetic mRNA to activate the immune system against the virus, needs to be kept at minus 70 degrees Celsius (-94 F) or below.

Rural areas in India and many poorer countries are likely to have a hard time in Pfizer’s coronavirus vaccine distribution. Plus, many hospitals in big cities also do not have the facilities to store vaccines at minus 70 degrees Celsius (-94 F) or below.

“This requirement makes the vaccine more challenging to deploy in settings where ultra-cold chain equipment may not be available or reliably accessible,” WHO said, adding that it was “working to support countries in assessing their delivery plans and preparing for use where possible”.

In India, PM Narendra Modi had held a meeting with chief ministers of all the states and Union Territories to review the coronavirus situation and asked them to start working on cold storage facilities for the coronavirus vaccine.

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“He said he will be vaccinated, he made this decision and was waiting until all formalities are completed,” the spokesman was quoted as saying to Rossiya 1 TV Channel on its website.

Russia launched a voluntary vaccination programme with the Russia-made Sputnik V vaccine earlier in December, starting with the most vulnerable groups in Moscow.

People over the age of 60 may begin to apply for shots on Monday, Moscow mayor Sergei Sobyanin said on his website on Sunday, the day after the Russian health ministry said the vaccine was approved for use by elderly people after a separate trial.

68-year-old Putin said earlier that the Russian vaccine was effective and safe and he saw no reason not to be vaccinated adding that he was waiting until it became available.

Since the start of the coronavirus outbreak in Russia, Putin has mainly worked remotely, held meetings via videolink and limited travel.

He said in August that one of his daughters had taken part in the clinical trial of the vaccine and felt well afterwards.

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He said he believes trials will show his firm has achieved a vaccine efficacy similar to Pfizer BioNTech and Moderna vaccines.

Earlier, several reports suggested that AstraZeneca vaccine may not be as good as the one made by Pfizer, already being distributed in the UK and other countries. Partial results suggest that the AstraZeneca shot is about 70 percent effective for preventing illness from coronavirus infection, compares to the 95% efficacy reported by Pfizer and its German partner BioNTech.

“We think we have figured out the winning formula and how to get efficacy that, after two doses, is up there with everybody else,” the chief executive said, while saying only that data would be published at “some point”.

The United Kingdom government announced on December 23 that the developers of the Oxford-AstraZeneca vaccine had submitted their data to the Medicines and Healthcare products Regulatory Agency (MHRA). Approval is expected to be granted to roll out the jab on January 4.

The Pfizer-BioNTech vaccine was the first coronavirus shot to be authorised for use by the UK’s independent medicines regulator and has been given to 600,000 of the country’s most vulnerable people since last month.

Earlier trials had shown different outcomes in the AstraZeneca shot’s efficacy. The vaccine initially showed an average 70 per cent effectiveness but that level jumped to 90 per cent depending on the dosage.

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Officials have indicated that India may not prefer Pfizer’s coronavirus vaccine over the other options available to the country for the prevention of Covid-19.

On December 13, coronavirus vaccine vials of Pfizer made their way to distribution site across the United States. The coronavirus vaccine shots are expected to be given to health care workers and nursing home residents in the US beginning Monday.

The same scenario won’t happen anytime soon in India, as the cost of Pfizer’s coronavirus vaccine is one of the primary reasons for it. At $37 i.e, Rs 2,728, the coronavirus vaccine candidate developed by Pfizer is much more expensive compared to the other vaccine candidates such as Oxford-AstraZeneca ‘Covishield’ and the $10 (Rs 737) vaccine candidate developed by Russia.

Bernstein analysts have said that assuming the cost per vial of Pfizer’s coronavirus vaccine to be at $3 (Rs 220.95), India may procure 680 million doses of the vaccine which would cost the country $1.9 billion. However, if the cost of Pfizer’s vaccine remains at $13, it would cost the country 12 times more. According to a report in Business Standard, Pfizer has said the company would only sell through government contracts.

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The move, announced on Wednesday, came after Russia said on October that its domestically produced Sputnik V vaccine was 92 percent effective at preventing coronavirus.

Teachers and medics will be the first to receive shots. President Putin said that the country will produce two million doses of the vaccine within the next few days.

“Let’s agree on this – you will not report to me next week, but you will start mass vaccination … let’s get to work already,” he told Deputy Prime Minister Tatyana Golikova.

The Kremlin earlier gave assurances that Russians were first in line to be vaccinated, with Moscow also discussing supply deals with other countries.

With 2,347,401 confirmed infections as of Wednesday, Russia has the fourth-largest number of COVID-19 cases in the world behind the United States, India and Brazil.

It has recorded 41,053 deaths related to COVID-19 since the start of the pandemic.

On December 2 authorities recorded 589 new daily deaths tied to the virus and 25,345 new infections.

The country’s overall rise in cases has slowed after witnessing a high on November 27. Instead of imposing mass lockdown during the second wave of infections, the officials opted for targeted regional curbs.

Museums, theatres and concert halls would be closed to the public in St Petersburg of over 5million people for the duration of Russia’s New Year holidays from December 30 to January 10.

Putin statement comes hours after the United Kingdom approved the Pfizer-BioNTech coronavirus vaccine for use that will be rolled out from early next week.

Sputnik V- named after the Soviet-era satellite is in third and final stage of clinical trials involving around 40,000 volunteers.

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The pharma company’s immediate focus is to conduct the Phase 3 trials successfully across sites in the country.

The company’s vaccine candidate, Covaxin, has been developed in collaboration with the Indian Council of Medical Research-National Institute of Virology using inactivated Sars-Cov-2. The virus was isolated in an ICMR lab.

The price of the vaccine is yet to be determined, as the company is still looking at the cost of product development.

Bharat Biotech received approval from the Drugs Controller General of India to conduct Phase 3 clinical trial to establish the efficacy of the vaccine candidate. The company has begun site preparatory exercises for Phase 3, recruitment and dosage will begin in November.

The trial is conducted in nealy 30 sites around 14 states. About 2,000 subjects are enrolled per hospital and will provide tow doses each of the vaccine and placebo recipients.

The pharma company is looking to supply for both government and private markets. It is also in its preliminary discussions with other countries for probable supply.

Nearly Rs 350-400 crore is invested for the development of vaccines and the new manufacturing facilities, which include investments for conducting the Phase 3 clinical trials, in the next three months.

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In India, an expert panel at the Central Drugs Standard Control Organisation (CDSCO) has asked Dr Reddy’s Laboratories to submit a revised protocol for conducting both phase 2 and phase 3 human clinical trials for the Russian vaccine against Covid-19, Sputnik V.
The Hyderabad-based pharmaceutical company had applied to the Drugs Controller General of India (DCGI) late last week, seeking permission to conduct phase-3 human clinical trials of the Russian vaccine.

According to reports, India’s drug regulator has refused the proposal from Dr Reddy’s Laboratories Ltd to conduct a large study in the country to evaluate Russia’s Sputnik-V Covid-19 vaccine and has asked it to first test the vaccine in a smaller trial.

The reason for the setback happened after the recommendations by the expert panel of the CDSCO. They noted that safety and immunogenicity data from early-stage studies being conducted overseas is small, with no inputs available on Indian participants.

India’s move comes as a setback for Russia’s plan to roll-out the vaccine even before full trials show how well it works, while pushing back its efforts to win approval for the vaccine in the country that leads the world on average number of new infections.

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