TOP TRENDING

The Oxford coronavirus vaccine is safe and, according to the phase 2 study, elicits a "robust" immune response


Oxford University's Covid vaccine triggers a "robust" immune system response and appears to work in the elderly. That was the result of a study that today marks another step towards ending the pandemic.

Scientists behind the project this morning released the results of an early attempt on the sting that found 99 percent of people showed strong signs of immunity.

The second phase study included 560 volunteers, most of whom were White and British, and showed that people of all ages appeared to respond equally well to the bump. It complements data released in July suggesting it would work safely for children under the age of 55. Studies in people with serious health problems and other ethnic groups are ongoing.

It's another breakthrough in the race to develop a vaccine to prevent Covid after it was found that the shocks carried out by Moderna and Pfizer and BioNTech were around 95 percent effective over the past week.

The Oxford results come from an earlier stage of the studies and therefore cannot estimate how well the vaccine protects against Covid, but it is a positive step nonetheless. Detailed results on how well it works are expected within weeks, the university said.

Research showed that people of all ages developed antibodies – virus-destroying substances of the immune system – within 28 days of their first vaccine dose, which were further increased after the second dose.

It was found that the vaccine caused more side effects than a false prick, but that they were "mild" and more common in young people than in older participants. Within the first week after the injection, more than eight in ten under 55-year-olds said that their arm was injured and that they later experienced tiredness, muscle pain or headache.

The UK has already pre-ordered 100 million doses of Oxford's Jab, made with pharmaceutical company AstraZeneca. So if it works and can be made fast enough it could be used to protect the majority of the UK population.

The bump could cost as little as £ 2 a dose, making it considerably cheaper than the £ 15-28 for Pfizer and Moderna vaccines that will cost the UK tens of millions.

Scientists today described the news as "promising" and "positive", adding that the British order could be big enough to achieve herd immunity if the vaccine comes out well. Health Secretary Matt Hancock said in a tweet: "There is still a lot to be done, but this is a really encouraging set of findings."

Oxford University scientists published the results of their second phase of the trial in the medical journal The Lancet this morning, which found it appears to work in adults of all ages

Oxford University scientists published the results of their second phase of the trial in the medical journal The Lancet this morning, which found it appears to work in adults of all ages

Oxford published the results of tests on its vaccine, called ChAdOx1 nCov-2019, today in The Lancet, a UK medical journal.

Volunteers in the study showed similar immune responses in all three age groups – they had been split into 18-55, 56-69, and over 70.

Observations of the 560 adults – including 240 over 70 years – showed that the vaccine was actually better tolerated and caused fewer side effects in the elderly.

The news that the sting appears to be safe and effective for the elderly is a huge step forward for the project as this is the group most at risk of severe Covid-19 and death.

Health officials in the UK have suggested that vaccines for younger adults and children have a lower priority and that vaccinating those over 50 and people with serious health problems would cover the vast majority of people who are likely to die.

Professor Deborah Dunn-Walters, Chair of the British Society for Immunology, described the announcement as "positive".

UK DRUGS WATCHDOG ON STANDBY FOR EXPERIMENTAL DATA FOR THE FIRST VACCINE

The UK Medicines Agency confirmed yesterday that it is waiting for Pfizer to submit the full results of its latest Covid-19 vaccine study so it can consider approval as the first coronavirus vaccine.

The drug company claimed yesterday that it can now show that its vaccine is safe, 95 percent effective and effective in the elderly.

Best known for producing Viagra, the US company announced that it would submit the required data to regulators in America and the UK "within days," which raises hopes that the UK will get its big of the Army backed operation to vaccinate millions of people could start soon as December 1st.

The UK Medicines Agency MHRA has carried out an "on-going review" of the vaccine and could therefore complete the approval process within days of receiving the application from Pfizer and BioNTech, a German company involved in the manufacture of the sting.

Dr. June Raine, Managing Director of MHRA, said: “The results Pfizer reports today are very encouraging and complement what they announced last week.

"We look forward to receiving the full results of the studies as soon as possible. After that, we will scrutinize the evidence of the vaccine's safety and effectiveness."

The UK has already pre-ordered 40 million doses of the vaccine and is expected to receive 10 million in the next month. The NHS is preparing to distribute it within 14 days. Professor Stephen Powis, the medical director of NHS England, said today the health service is working "incredibly hard" to prepare.

The final trial results from Pfizer and BioNTech showed that only eight out of more than 20,000 people who received the vaccine received the coronavirus, compared to 162 people who were given a fake sting. A total of 10 people received severe Covid-19, one of whom had received the real vaccine.

An independent safety committee has "reported no serious safety concerns with the vaccine" since the final phase of the trial began in July, Pfizer said. Side effects were limited – the most common were fatigue, which 3.8 percent of people had, and headache (2 percent).

The announcement is an improvement on Pfizer's earlier estimate that the vaccine was and is 90 percent effective Just days after rival firm Moderna claimed their own push was 94.5 percent effective, it sparked fears that Britain had tagged its car on the wrong project because No10 had not bought cans.

She said, “While this is an ongoing study, the initial results are encouraging.

"The vaccine appears to be well tolerated in all age groups, with older people reporting fewer side effects."

Dr. Gillies O & # 39; Bryan-Tear of the Faculty of Pharmaceutical Medicine stated, “The aging of the immune system in the elderly can make vaccines less effective.

& # 39; This is especially important as Covid has a much higher mortality rate in the elderly.

One indication from the current study is that older people were less responsive to the vaccine – less fever, less injection site pain and swelling – but fortunately, the immune responses in the elderly were indistinguishable from those in younger patients.

"This suggests, but does not prove, that protection from the disease will be similar in the elderly and young."

Dr. Michael Tildesley, a Warwick University epidemiologist advising SAGE, said the vaccine could be a "game changer".

He told BBC Breakfast that the number of government-purchased doses could propel Britain towards "this immunity to magical herds".

Successful protection of the elderly is the "key," he said.

The volunteers in the study were divided into two groups and received either two doses of the real vaccine candidate or a placebo meningitis vaccine.

The placebo is given so scientists can be sure that any side effects people report are actually caused by the vaccine, and not just by the injection itself or psychologically.

None of the participants were found to have any serious health issues related to the vaccine, the researchers said.

Dr. Maheshi Ramasamy, Oxford Vaccine Group Investigator and Consultant Doctor, said: "Older adults are a priority group for Covid-19 vaccination because they are at increased risk of serious illnesses, but we know they tend to get a worse vaccine." have answers.

& # 39; We were pleased to see that our vaccine was not only well tolerated in older adults, but also stimulated immune responses similar to those seen in younger volunteers.

"The next step will be to see if this leads to protection from the disease itself."

The vaccine is known as a recombinant viral vector vaccine and is made using some of the real coronavirus, but not enough to cause disease.

In this case, scientists modified a cold virus found in monkeys to look like the coronavirus by outwardly exposing the "spike" proteins found on the Covid virus.

This means that when the vaccine is injected, the body gives the impression that it is seeing the coronavirus and the immune system is attacking it.

In doing so, it develops an understanding and a memory of how to fight viruses that have the same tips on the outside. So if it does actually encounter the coronavirus, it should immediately know how to destroy it before it can cause Covid-19.

In other coronavirus news:

  • Experts warn the government to relax social distancing this Christmas because it will "throw fuel on the Covid fire". One said it was "pointless to have a merry Christmas and then bury friends and relatives in January".
  • But rebellious Tory MPs have taken the opposite view: "Freedom isn't just for Christmas" and urged Boris Johnson to finally abolish the lockdown rules.
  • Chancellor Rishi Sunak said the UK economy will still try to recover from the effects of Covid-19 in 2024 as he will present an economic forecast for Parliament next Wednesday.
  • A BBC documentary will reveal that SAGE used unverified data from Wikipedia to model the coronavirus outbreak during the first wave and did not have a single expert on the topic on its panel at the time.
  • The average UK house price is up £ 4,000 in one month as a result of government stamp duty relief.
  • Boris Johnson has refused to apologize for the friends money scandal that emerged after Tory party donors and start-ups won multi-million pound PPE contracts.
Although in the early stages of the Oxford trial the vaccine wasn't tested on many people in non-white groups or on people with serious health problems, one larger study recruited people from around the world to see if the stitch work was done on everyone works (Image: A woman) in Brazil receives a dose of the vaccine)

Although in the early stages of the Oxford trial the vaccine wasn't tested on many people in non-white groups or on people with serious health problems, one larger study recruited people from around the world to see if the stitch work was done on everyone works (Image: A woman) in Brazil receives a dose of the vaccine)

Oxford's vaccine is made by Cambridge-based pharmaceutical company AstraZeneca

Oxford's vaccine is made by Cambridge-based pharmaceutical company AstraZeneca

The Oxford announcement comes after pharmaceutical companies Moderna and Pfizer and BioNTech reported late-stage clinical trial results this week.

Pfizer and BioNTech said yesterday the final results of their clinical study suggested their vaccine was 95 percent effective just days after Moderna claimed its own sting showed 94.5 percent effectiveness.

The UK is currently in the process of getting these through regulatory approval and will buy millions of cans if approved.

Up to five million people could be vaccinated with Pfizer's sting before the end of the year if the process goes smoothly.

Oxford's vaccine is expected to be significantly cheaper than either, was ordered in bulk, and is easier to store and deliver.

While Moderna & # 39; s is expected to cost between £ 24-28 per dose and Pfizer around £ 15 per dose, Oxford & # 39; s could cost as little as £ 2.23.

Manufacturer AstraZeneca said it would produce the first batch of vaccines "at cost," which means it won't benefit from them, although it could increase the price in the future.

The Oxford vaccine is also likely to be cheaper to store and transport, as previous versions of the same technology are suitable for room temperature storage.

Pfizer and Moderna both say their vaccines must be frozen during transit and then kept cold until they are used in a clinic.

Pfizer will be particularly challenging as it has to be kept at -70 ° C (-94 ° F) throughout the supply chain, which requires special freezers.

Moderna's is less difficult as it just needs to be frozen during transport at a temperature that normal freezers can reach and then stored in the refrigerator.

Oxfords can be kept stable at temperatures between 2 ° C and 8 ° C, which means they can be kept in a standard refrigerator at all times, eliminating the need to buy new equipment.

Today's Lancet study also found that the vaccine developed with AstraZeneca was less likely to cause local injection site reactions and symptoms on the day of vaccination in older adults than in the younger group.

The side effects were mild – injection site pain and tenderness, fatigue, headache, fever, and muscle pain – but more common than the control vaccine.

In the six months since the first dose, there were 13 serious adverse events, none of which were related to either of the two study vaccines.

The authors note some limitations to their study, including that participants in the oldest age group had a mean age of 73 to 74 years and few underlying health conditions, so they may not be representative of the general elderly population, including those in home care live settings or over 80 years old.

Phase 3 studies with the vaccine are ongoing. Early readings of the effectiveness are possible in the coming weeks.

The UK authorities have ordered 100 million doses of the vaccine – enough to vaccinate most of the population – should it get regulatory approval.

The Oxford results come after Pfizer and BioNTech announced that their vaccine candidate has 95 percent effectiveness and 94 percent effectiveness in people aged 65 and over.

Forty million doses of this vaccine have been bought by the UK. The rollout may begin in early December when regulators give the go-ahead for vaccination.

Earlier this week, US biotech company Moderna released data suggesting its vaccine is nearly 95 percent effective.

HOW DO THE OXFORD, MODERNA AND PFIZER / BIONTECH Vaccines compare?

Moderna and Pfizer / BioNTech have both released interim clinical trial results for their end-stage vaccines, both of which indicate that they are extremely effective.

Oxford University has published the results of its second phase, showing that the sting induces an immune response and is safe to use. It's not yet clear how well it protects against coronavirus in the real world.

How to Compare:

PFIZER (US) & BIONTECH (DE)

mRNA vaccine – Genetic material from the coronavirus is injected to stimulate the immune system to make "spike" proteins and learn how to attack them.

mRNA vaccine – both Moderna, Pfizer and BioNTech vaccines work the same way.

Recombinant Viral Vector Vaccine – A harmless cold virus taken from chimpanzees has been engineered to produce the "spike" proteins and look like the coronavirus.

94.5% effective (90 positive in the placebo group, 5 positive in the vaccine group).

95% effective (160 positive in the placebo group, 8 positive in the vaccine group).

The effectiveness is unknown as the studies are ongoing. It triggered a "robust" immune system response in 99% of people in early studies.

Moderna confirmed that countries placing smaller orders, such as the UK's five million cans, will pay between £ 24 and £ 28 per dose. The US has secured 100 million doses for $ 1.525 billion (£ 1.16 billion), suggesting it will cost $ 15.25 (£ 11.57) per dose.

The US will pay $ 1.95 billion (£ 1.48 billion) for the first 100 million doses, which is $ 19.50 (£ 14.80) per dose.

Estimated to cost £ 2.23 per dose. The UK's full 100 million dose supply could add up to just £ 223 million.

The UK has ordered five million cans that will be available from March 2021. Moderna will produce 20 million cans this year, which is expected to remain in the US.

The UK has already ordered 40 million cans, 10 million of which could be available in 2020. The first vaccinations are expected in December.

The UK has already ordered 100 million cans and is expected to come first to get the cans once approved.

What side effects does it cause?

Moderna said the vaccine was "generally safe and well tolerated". Most of the side effects were mild or moderate, but included pain, fatigue and headache, which "generally" were short-lived.

Pfizer and BioNTech did not provide a breakdown of the side effects, but said the Data Monitoring Committee "did not report any serious safety concerns."

Oxford said there were no serious safety concerns. Mild side effects were relatively common in small studies. Many participants reported that their arm hurt after the shock and that they later suffered from headache, fatigue, or muscle pain. Further data is collected.

What do we know about Oxford's coronavirus vaccine?

When will it be done?

The results of a study that tested how well it works are expected to be released within weeks, the team said today.

Once the data is ready, it will be reviewed by the health authority MHRA, which will decide if it is suitable for the public.

According to official figures, the NHS is preparing to give a Covid-19 vaccine as early as December if one turns out to work.

When can you get one?

Despite the fact that the government has signed a contract for 100 million doses, only about four million should actually be available by the end of this year, vaccine chief Kate Bingham has announced. This would only cover two million people.

The first wave of vaccinations would not be good enough to bring society back to normal immediately, Ms. Bingham said.

In the UK, a vaccination priority list has been drawn up, with nursing home residents and workers, over 80s and healthcare workers at the top of the queue, comprising at least six million people.

Will it work?

Early studies, including today's results, suggest that the vaccine stimulates the immune system in the right way, forcing the body to produce antibodies specific for the coronavirus.

This means the surge should effectively stop Covid-19, but what proportion of the people it works for and how long the protection will last remains to be seen.

Professor Sarah Gilbert, head of the Oxford team, said before the studies began that she was 80 percent confident of its success "based on other things we did with this type of vaccine."

What obstacles did the team face?

The experiments were interrupted three times to investigate serious events in volunteers.

On two occasions, in July and September, the study participants had developed symptoms that were feared to be caused by the shock. And a man in Brazil died of Covid-19 in October – but is said to have received the placebo push.

In each case, independent evaluators found it safe to continue the stab trials after they had been stopped for several days.

Today's update found that there were 13 serious health issues in the second phase of the study, none of which were linked to the vaccine.

How does it work?

The vaccine is known as the "Recombinant Viral Vector Vaccine". It's made with a piece of the virus that can't cause disease.

In this case, a cold virus (adenovirus) was used and processed by chimpanzees to develop the spikes visible on the outside of the coronavirus.

If the vaccines can successfully mimic the spikes in a person's bloodstream and stimulate the immune system to make special antibodies to attack them, it could train the body to destroy the real coronavirus if it becomes infected with it in the future.

Is it safe?

Probably based on the first results of experiments. However, this won't become clear until the vaccine has completed its third clinical trials. It won't be introduced until it's proven safe.

Although it was made in a flash – it went through the stages of vaccine development that typically take five years in just four months – Professor Gilbert said none of the normal safety steps had been overlooked.

Chimpanzee adenoviral vectors are a very well-studied type of vaccine that has been safely used on thousands of subjects.

How was it tested?

Around 1,100 British people were involved in the phase 1 study. Around 11,000 adults and children across the UK were enrolled in Phase II.

More than 50,000 people worldwide will take part in phase III studies, according to the scientists involved. Half will get the real vaccine candidate while others will get a placebo.

In September, AstraZeneca announced that the shock had so far been given to 18,000 people around the world.

Who was the vaccine made and who does it belong to?

Clinical teams at Oxford University's Jenner Institute and the Oxford Vaccine Group began development of the ChAdOx1 nCoV-19 vaccine in January.

After teaming up with pharmaceutical giant AstraZeneca in May, the engraving was named AZD1222.

The intellectual rights to his vaccine are owned by the University of Oxford and a spin-out company called Vaccitech.

How does it compare to other vaccines?

The Oxford vaccine is the same as Janssen's, which is also a recombinant vector vaccine using a human adenovirus. GSK / Sanofi works in a similar way, but with an additional adjuvant that can boost the immune system.

Jabs made by Pfizer / BioNTech and Moderna – the first results released this month – are known as messenger RNA (mRNA) vaccines.

They insert genetic code from the virus into the body to cause it to make the spike proteins. This provokes the immune system to make antibodies. This experimental technology has never been demonstrated in humans before.

A team at Imperial College London is also among the developers of an RNA vaccine candidate. An attempt is made to transport the RNA in droplets of liquid that are injected into the bloodstream.

What other countries have secured cans?

France, Germany, Italy and the Netherlands have secured 400 million cans. Australia has secured cans for its population of 25 million people. The US has secured 100 million cans. The Serum Institute of India has also secured a billion doses. AstraZeneca has said the cans will be distributed fairly.

How much is it?

The vaccine may cost as little as £ 2.23 per dose, compared to an estimated £ 15 per dose by Pfizer / BioNTech.

AstraZeneca has announced that it will not benefit from this, but it may earn additional royalties if the coronavirus becomes an endemic infection like the flu. The US has spent $ 1.2 billion (£ 930 million) securing cans, which means they're worth $ 4 (£ 3.10) each.

THE SIX CORONAVIRUS Vaccines UK HAVE PRE-ORDERED

BIONTECH / PFIZER – 40MILLION

This is the first coronavirus vaccine shown to work. In a study of more than 43,000 people, it was found to be 90 percent effective.

There are some concerns about the two-dose burst as it largely needs to be kept in an ultra-cold store at around minus 70 ° C.

However, the interim results suggest that it is one of the most successful vaccines ever developed. It uses genetic code in a droplet of fat to tell the body to make the coronavirus spike protein, which causes the body's immune system to make antibodies.

Ugur Sahin and his wife Oezlem are the brains behind the vaccine, and the German couple BioNTech are developing it together with the US pharmaceutical giant Pfizer. The UK is promised 10 million cans by the end of the year and 30 million next year. So far only hundreds of thousands have been produced.

OXFORD UNIVERSITY / ASTRAZENECA – 100MILLION

The results of this vaccine are hoped for this week. Up to 100 million doses have been promised in the UK and 13,000 UK volunteers have participated in global studies.

The vaccine uses a deactivated chimpanzee cold virus that contains genetic code that causes cells to produce the spike protein on the outside of the coronavirus so the body can recognize it and fight it off.

JANSSEN – 30 MILLION

An international study of 30,000 people, including 6,000 in the UK, begins today to measure the effectiveness of two doses of vaccine. It works like the Oxford vaccine, but uses a cold virus to provide the genetic code that causes cells to produce the coronavirus spike protein.

NOVAVAX Vaccine – 60 MILLION

The vaccine from the US biotech company Novavax was tested in a British study in September and has so far recruited 10,000 people.

The vaccine contains a synthesized copy of the coronavirus spike protein and a "booster" to increase the immune response. The UK is promised 60 million doses, which are hoped to be available by mid-2021.

VALNEVA – 60 MILLION

This is a traditional vaccine as opposed to BioNtech's more innovative design. The immune system is sure to be exposed to an inactivated version of the coronavirus.

Up to 190 million doses are promised in the UK, although it has not yet been tested in humans. Up to 100 million of these are to be produced in the company's factories in Livingston, near Edinburgh. It is unlikely to be available until the end of next year.

GSK / SANOFI – 60 MILLION

British drug giant GlaxoSmithKline has reportedly made millions of doses of a "booster" for three vaccines.

The company offers its adjuvant technology and has partnered with Sanofi, Medicago and Clover Pharmaceuticals. The first results on whether any of the three traditional protein-based vaccines will work are expected in the first half of next year.

(tagsToTranslate) Dailymail (t) Messages (t) Coronavirus (t) Pfizer