The Russian coronovirus vaccine showed around 92% protection against Covid-19, late stage trial results published in The Lancet reveal.
Sputnik V vaccine has also been deemed to be safe – and offer complete protection against hospitalization and death.
The vaccine was initially met with some controversy after being rolled out before the final trial data had been released.
However, scientists said the Russian vaccine’s benefit has now been demonstrated.
Sputnik V joins the ranks of proven vaccines alongside Pfizer, Oxford/AstraZeneca, Moderna and Janssen.
It works in a similar way to the Oxford/AstraZeneca vaccine developed in the UK, and the Janssen vaccine developed in Belgium.
Sputnik V uses a cold-type virus, engineered to be harmless, as a carrier to deliver a small fragment of the coronavirus to the body.
Safely exposing the body to part of the virus’s genetic code in this way allows it to recognize the threat and learn to fight it off, without risking becoming ill.
After being vaccinated, the body starts to produce antibodies specially tailored to the coronavirus.
This means the immune system is primed to fight coronavirus when if it encounters it for real.
The Russian vaccine can be stored at temperatures of between 2 and 8C degrees (a standard fridge is roughly 3-5C degrees) making it easier to transport and store.
But unlike other similar vaccines, Sputnik V uses two slightly different versions of the vaccine for the first and second dose – given 21 days apart.
They both target the coronavirus’s distinctive “spike”, but use different vectors – the neutralized virus that carries the spike to the body.
The idea is that using two different formulas boosts the immune system even more than using the same version twice – and may 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.
There were no deaths or serious illness in the vaccinated group linked to the Russian vaccine.
As well as Russia, Sputnik V is being used in a number of other places, including: Argentina, Venezuela, Hungary, UAE, Iran, Palestinian territories.
The authors of the Lancet paper pointed out the analysis only included symptomatic cases of Covid, and more work would need to be done to understand whether it stops even asymptomatic cases, and prevents the virus from being passed on by vaccinated people.
Five people have died in a fire at Serum Institute of India, the world’s largest vaccine manufacturer.
The fire started at a building which was still under construction at the Serum Institute facilities in Pune on January 21.
Footage showed thick plumes of smoke billowing from a building on the company’s sprawling site.
However, the company said vaccine production would not be affected. The cause of the fire has not been identified.
The blaze was later brought under control, but the city’s mayor confirmed that five people had died.
Serum Institute’s CEO Adar Poonawalla tweeted: “We have just received some distressing updates; upon further investigation we have learnt that there has unfortunately been some loss of life at the incident.
“We are deeply saddened and offer our deepest condolences to the family members of the departed.”
Adar Poonawalla said there would be no impact on the production of the Oxford-AstraZeneca vaccine, known locally as Covishield, “due to multiple production buildings that I had kept in reserve to deal with such contingencies”.
Covishield is one of two vaccines approved by the Indian government for use in its inoculation program, which began last week and is the largest in the world.
India aims to vaccinate 300 million people by early August.
Many other low and middle-income countries are also depending on the Serum Institute for production of the Oxford-AstraZeneca vaccine.
India has recorded the second-highest number of Covid-19 infections in the world after the United States. Since the pandemic began India has confirmed more than 10.6 million cases and almost 153,000 deaths, according to figures from Johns Hopkins University.
According a study by the University of Texas, the Pfizer/BioNTech vaccine can still target a key mutation that has emerged in two new variants of coronavirus.
However, this is only one of many mutations that are found in the new forms of the virus.
So while the study has been welcomed, it is not being seen as definitive scientific evidence about how the vaccine will perform.
New variants have been detected in the UK and South Africa.
Both variants are spreading more quickly and this has raised questions over what level of protection vaccines can offer against them.
The widely held view is that vaccines will still work, but researchers are on the hunt for proof.
The study focuses on a mutation called N501Y, which is emerged in both new variants.
This is thought to be important because it is in the part of the virus that makes first contact with our body’s cells and changes could make it easier to get in and cause an infection.
The researchers created two forms of the virus – one with and one without the mutation – and then bathed those viruses in blood samples taken from 20 patients that had been vaccinated in clinical trials.
The study results showed the immune systems of vaccinated patients were able to take out the new mutation.
However, the variant that emerged contain multiple mutations whose combined effects may help the virus evade the immune system.
The US mass vaccination will begin on December 14 after it was authorized for emergency use, officials say.
The first three million doses of the Pfizer/BioNTech coronavirus vaccine would be shipped “across all states” this weekend, said General Gustave Perna, who is overseeing distribution.
The vaccine offers up to 95% protection against Covid-19 and was deemed safe by the FDA.
On December 12, the US recorded a daily toll of 3,309 Covid-related deaths.
The figure, reported on the Johns Hopkins University website, is the highest total in a single day anywhere in the world.Coronavirus deaths have been rising sharply since November in the US.
Authorizing the emergency use of the Pfizer/BioNTech vaccine on December 11, the FDA – which had come under intense pressure from the Trump administration to do so – said the move was a “significant milestone” in the pandemic.
During a news conference on December 12, Gen. Perna – speaking for the government’s vaccination campaign Operation Warp Speed – said doses of the vaccine would be packed into shipping containers for transportation “within the next 24 hours”.
He said: “Expect 145 sites across the states to receive the vaccine on Monday, another 425 sites on Tuesday, and the final 66 sites on Wednesday.”
He also said that next week’s distribution would complete the initial delivery of the Pfizer/BioNTech vaccine and cover about three million people.
Gen. Perna told reporters he was “100% confident” that the doses “needed to defeat the enemy Covid” would be transported safely.
However, he warned that while it had been a week of progress, “we are not done until every American has access to a vaccine”.
The Pfizer vaccine has already received regulatory approval in the UK, Canada, Bahrain and Saudi Arabia. Like those countries, US health authorities are expected to prioritize health workers and care home residents for the first doses.
More Americans outside the highest-priority groups are likely to be able to get the vaccine in January, with general availability expected by April.
On December 10, medical experts advising the FDA recommended the emergency-use authorization. A 23-member panel concluded the vaccine’s benefits outweighed its risks.
Emergency use, the FDA said, was not the same as full approval, which would require Pfizer to file a separate application to secure.
The Pfizer/BioNTech product was the first coronavirus vaccine to show promising results in the latter stages of its testing process.
It is a new type called an mRNA vaccine that uses a tiny fragment of genetic code from the pandemic virus to teach the body how to fight Covid-19 and build immunity.
The FDA said: “The vaccine contains a small piece of the [Covid-19] virus’s mRNA that instructs cells in the body to make the virus’s distinctive ‘spike’ protein.”
Elderly people in care homes and care home staff are top of the priority list, followed by over-80s and health and care staff.
However, because of the limited stocks and need to store at -70C, the very first vaccinations are likely to take place at hospitals so care home residents may not be immunized until later.
The Pfizer/BioNTech product is the fastest vaccine to go from concept to reality, taking only 10 months to follow the same steps that normally span 10 years.
The UK has already ordered 40 million doses of the free jab – enough to vaccinate 20 million people.
The doses will be rolled out as quickly as they can be made by Pfizer in Belgium, Matt Hancock said, with the first load next week and then “several millions” throughout December.
UK’s PM Boris Johnson said: “It’s the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again.”
Pfizer/BioNTech vaccine will be non-compulsory and there will be three ways of vaccinating people across the UK:
Hospitals
Vaccination centers
In the community, with GPs and pharmacists.
Around 50 hospitals are on stand-by and vaccination centers – in venues such as conference centers or sports stadiums – are being set up now.
Because the initial doses are being delivered to hospitals, which already have the facilities to store the vaccine at -70C, the very first vaccinations are likely to take place at hospital hubs – for care home staff, NHS staff and patients – so none of the vaccine is wasted.
It is thought the vaccination network could start delivering more than one million doses a week once enough doses are available.
Pfizer and BioNTech are filing for emergency authorization in the US of their Covid-19 vaccine on Friday, November 20.
The FDA will decide if the vaccine is safe to roll out.
It is not clear how long the FDA will take to study the data. However, the US government expects to approve the vaccine in the first half of December.
Data from an advanced trial showed the vaccine protects 94% of adults over 65.
Pfizer’s and BioNTech’s trial involved 41,000 people worldwide. Half were given the vaccine, and half a placebo.
If FDA authorization does come in the first half of next month, Pfizer and BioNTech will “be ready to distribute the vaccine candidate within hours”, the two companies said.
This would be remarkably quick for vaccine development – within 10 months of detailing the genetic code. The average wait for approval in the US is nearer eight years.
On November 19, Pfizer CEO Albert Bourla said that the filing for emergency use was a “milestone in our journey to deliver a Covid-19 vaccine to the world”.
Initial doses would be scarce, though, and the Centers for Disease Control and Prevention (CDCP) will decide who is first in line.
European Commission president Ursula von der Leyen said the EU could move quickly too – by the end of the year.
Pfizer’s and BioNTech’s coronavirus vaccine appears to protect 94% of adults over 65 years old.
More data released from their ongoing phase three trial suggests the vaccine works equally well in people of all ages, races and ethnicities.
The companies say they will now apply for authorization for emergency use of the jab in the US.
The findings are based on two doses given to more than 41,000 people around the world.
Last week, Pfizer and BioNTech published preliminary data showing the vaccine offered 90% protection against Covid-19 and there were no safety concerns.
This was followed by impressive data on another vaccine, made by US company Moderna, suggesting nearly 95% protection.
November 18 data from Pfizer and BioNTech, which builds on last week’s data, suggests the vaccine is 95% effective based on 170 cases Covid-19 developing in volunteers.
Just eight were in the group given the vaccine, suggesting it offers good protection. The rest of the cases were in the placebo group given a dummy jab.
Scientists said the data was further encouraging news.
Although the full trial data has yet to be published, the companies say there have been no serious safety concerns.
However, they did notice headaches and fatigue in about 2% of volunteers given the vaccine, although older people seemed to experience minimal side effects.
There is also evidence that the vaccine protects against severe Covid – but this is based on only 10 cases.
It’s still unclear how long protection from the vaccine lasts and if it stops people transmitting the virus.
In the trial, 42% of all participants are from diverse ethnic backgrounds and 41% are aged between 56 and 85 years old.
The trial, which is testing people at 150 sites in the US, Germany, Turkey, South Africa, Brazil and Argentina, will collect data on the safety and efficacy of the vaccine for another two years.
Pfizer and BioNTech expect to produce up to 50 million doses of the vaccine this year and up to 1.3 billion doses by the end of 2021.
There are hundreds of vaccines in development around the world, and about a dozen in the final stages of testing, known as phase three.
The first two to show any results – made by Pfizer-BioNTech and Moderna – both use an experimental approach, called mRNA, which involves injecting part of the virus’s genetic code into the body to train the immune system.
Antibodies and T-cells are then made by the body to fight the coronavirus.
Russia’s Sputnik vaccine has also released early data from phase three based on a smaller number of volunteers and Covid cases.
There are some logistical challenges with mRNA vaccines, namely the need to store them at cold temperatures.
The Pfizer vaccine must be stored at around minus 80C, although it can be kept in a fridge for five days.
Moderna’s vaccine needs to be stored at minus 20C for up to six months and kept in a standard fridge for up to a month.
A new coronavirus vaccine made by Moderna showed nearly 95% protection against Covid-19.
Early data results come hot on the heels of similar results from Pfizer, and add to growing confidence that vaccines can help end the pandemic.
Pfizer and Moderna used a highly innovative and experimental approach to designing their vaccines.
Moderna says it is a “great day” and they plan to apply for approval to use the vaccine in the next few weeks.
However, this is still early data and key questions remain unanswered.
The trial involved 30,000 people in the US with half being given two doses of the vaccine, four weeks apart. The rest had dummy injections.
The analysis was based on the first 95 to develop Covid-19 symptoms.
Only five of the Covid cases were in people given the vaccine, 90 were in those given the dummy treatment. The company says the vaccine is protecting 94.5% of people.
The data also shows there were 11 cases of severe Covid in the trial, but none happened in people who were immunized.
Moderna says it will apply to regulators in the US in the coming weeks. It expects to have 20 million doses available in the country.
The company hopes to have up to one billion doses available for use around the world next year and is planning to seek approval in other countries too.
We still do not know how long immunity will last as volunteers will have to be followed for much longer before that can be answered.
There are hints it offers some protection in older age groups, who are most at risk of dying from Covid, but there is not full data.
It is not known whether the vaccine just stops people becoming severely ill, or if it stops them spreading the virus too.
All these questions will affect how a coronavirus vaccine is used.
No significant safety concerns have been reported, but nothing, including paracetamol, is 100% safe.
Short lived fatigue, headache and pain were reported after the injection in some patients.
Both vaccines use the same approach of injecting part of the virus’s genetic code in order to provoke an immune response.
The preliminary data we have seen so far is very similar – around 90% protection for the Pfizer/BioNTech vaccine and around 95% for Moderna’s.
However, both trials are still taking place and the final numbers could change.
Moderna’s vaccine appears to be easier to store as it remains stable at minus 20C for up to six months and can be kept in a standard fridge for up to a month.
Pfizer’s vaccine needs ultra-cold storage at around minus 75C, but it can be kept in the fridge for five days.
The Sputnik V vaccine, developed in Russia, has also released very early data which suggests it is 92% effective.
The first report on the Russian coronavirus vaccine, named Sputnik-V, says early tests showed signs of an immune response.
The report published by medical journal The Lancet said every participant developed antibodies to fight the virus and had no serious side effects.
Russia licensed the vaccine for local use in August, the first country to do so and before data had been published.
However, experts say the trials were too small to prove effectiveness and safety.
But Moscow has hailed the results as an answer to critics. Some Western experts have raised concerns about the speed of Russia’s work, suggesting that researchers might be cutting corners.
Last month, President Vladimir Putin said the vaccine had passed all the required checks and that one of his own daughters had been given it.
Two trials were conducted between June and July, The Lancet paper said. Each involved 38 healthy volunteers who were given a dose of the vaccine and then a booster vaccine three weeks later.
The participants – aged between 18 and 60 – were monitored for 42 days and all of them developed antibodies within three weeks. Among the most common side effects were headaches and joint pain.
The trials were open label and not randomized, meaning there was no placebo and the volunteers were aware they were receiving the vaccine.
According to the report: “Large, long-term trials including a placebo comparison, and further monitoring are needed to establish the long-term safety and effectiveness of the vaccine for preventing Covid-19 infection.”
A third phase of trials will involve 40,000 volunteers from “different age and risk groups,” according to the paper.
Russia’s vaccine uses adapted strains of the adenovirus, a virus that usually causes the common cold, to trigger an immune response.
Kirill Dmitriev, head of a Russian investment fund behind the vaccine, said during a news conference that the report was “a powerful response to the skeptics who unreasonably criticized the Russian vaccine”.
He said that 3,000 people had already been recruited for the next phase of trials.
Health Minister Mikhail Murashko said Russia would start vaccinations from November or December, with a focus on high-risk groups.
However, experts warned that there was still a long way to go until a vaccine could enter the market.
According to the WHO, there are 176 potential vaccines currently being developed worldwide. Of those, 34 are currently being tested on people. Among those, eight are at stage three, the most advanced.
Russia is preparing to start a mass vaccination campaign against coronavirus in October, the health minister has said.
Health minister Mikhail Murashko said that doctors and teachers would be the first to receive the vaccine, local media reported.
Russia’s first potential vaccine would be approved by regulators this month, Reuters reports, citing anonymous sources.
However, some experts are concerned at Russia’s fast-track approach.
On July 31, Dr. Anthony Fauci said he hoped that Russia – and China – were “actually testing the vaccine” before administering them to anyone.
The leading infectious disease expert in the US has said that America should have a “safe and effective” vaccine by the end of this year.
“I do not believe that there will be vaccines so far ahead of us that we will have to depend on other countries to get us vaccines,” Anthony Fauci told US lawmakers.
Scores of possible coronavirus vaccines are being developed around the world and more than 20 are currently in clinical trials.
Mikhail Murashko, quoted by Interfax news agency, said that the Gamaleya Institute, a research facility in Moscow, had finished clinical trials of a vaccine and that paperwork was being prepared to register it.
“We plan wider vaccinations for October,” he said, adding that teachers and doctors would be the first to receive it.
Last month, Russian scientists said that early-stage trials of an adenovirus-based vaccine developed by the Gamaleya Institute had been completed and that the results were a success.
Last month the US, UK and Canada security services said a Russian hacking group had targeted various organizations involved in Covid-19 vaccine development, with the likely intention of stealing information.
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