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AstraZeneca-Oxford Covid vaccine authorised to be used by European regulator

Head nurse Sam Foster is holding a vial of Oxford University / AstraZeneca COVID-19 vaccine on January 4, 2021 at Churchill Hospital in Oxford, South West England.

Steve Parsons | AFP | Getty Images

LONDON – The coronavirus vaccine developed by AstraZeneca and Oxford University has been approved by the European Medicines Agency, the European Medicines Agency.

The EMA said on Friday that it had assessed the safety and effectiveness of the Covid vaccine and recommended that the European Commission, the EU’s executive branch, give formal conditional marketing authorization.

It also said the shot would likely work in the elderly after a German vaccine committee recommended Thursday not to give the vaccine to those over 65.

“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to fight the pandemic and protect their citizens,” said Emer Cooke, Executive Director of EMA, in a statement on Friday.

“As in previous cases, the CHMP has rigorously evaluated this vaccine and the scientific basis of our work underpins our firm commitment to protecting the health of EU citizens,” said Cooke, referring to the EMA’s Committee on Medicinal Products for Human Use.

The vaccine is already being used in the UK, having received approval in late December, and now, along with the Pfizer BioNTech shot, which has already been approved for use in the UK, makes up most of the EU shocks administered in the country.

Approval comes at a difficult time for the EU as the vaccination program is at best sluggish and very prone to supply shortages.

He has been dealt two blows in the past few weeks, one from Pfizer, who announced that it would temporarily cut production while improving production capacity at its Belgian facility. Then last Friday it was reported that AstraZeneca would deliver far fewer cans to the block than originally expected due to production problems at its plants in the Netherlands and Belgium this spring.

The delays have sparked a crisis in the EU which has announced it will curb exports of coronavirus vaccines from the bloc to give citizens priority. These controls are expected to last until March.

On Wednesday, the EU called on AstraZeneca to do whatever it takes to deliver its agreement to supply millions of coronavirus vaccines, suggesting that the company is diverting some supplies from its UK manufacturing facilities to the EU.

German doubt

On Thursday, doubts arose about the possible approval of AstraZeneca’s vaccine after the German vaccine committee recommended that the vaccine only be offered to people between the ages of 18 and 64.

This is due to the fact that there is insufficient data to assess the effectiveness in people over 65 years of age.

Older study participants were later admitted to phase 3 clinical trials with the AstraZeneca shot, which took place in the UK and Brazil and earlier in South Africa. As a result, there are fewer data on effectiveness in those over 65.

AstraZeneca said this data would be collected when its study results were published in the medical journal The Lancet in December: “As older age groups were recruited later than younger age groups, there was less time to collect cases and, consequently, efficacy data in these cohorts The number of cases is currently limited, but additional data will be available in future analyzes, “it said.

On Friday when the AstraZeneca approval was announced, the EMA announced that older participants (over 55 years of age) had not yet had enough results to establish a number for the vaccine’s effectiveness in this group. However, it states that “protection is expected because an immune response is observed in this age group and is based on experience with other vaccines”.

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Health

UK rolls out AstraZeneca-Oxford vaccine

Brian Pinker, 82, will receive the University of Oxford / AstraZeneca COVID-19 COVID-19 vaccine on January 4th, 2021 from Nurse Sam Foster at Churchill Hospital in Oxford, South West England. –

STEVE PARSONS | AFP | Getty Images

LONDON – UK has started rolling out the coronavirus vaccine developed by AstraZeneca and Oxford University. This is another step in the fight against the coronavirus pandemic.

The country’s National Health Service (NHS) is the first in the world to use the push after it was approved for use in the UK by the Medicines and Health Products Regulatory Agency (MHRA) last week. The NHS said 82-year-old Brian Pinker became the first person in the world to receive the bump on Monday morning.

The approval and use of the Oxford-AstraZeneca vaccine are seen as a boon in the race against Covid-19 as it is cheaper than the alternatives developed by Pfizer, BioNTech and Moderna.

In addition, unlike other vaccines, it can be stored, transported, and handled under normal refrigeration conditions (2 to 8 degrees Celsius or 36 to 46 degrees Fahrenheit) for at least six months.

When the vaccine was approved last week, AstraZeneca stated its goal of “delivering millions of doses in the first quarter” under its contract with the UK government to deliver up to 100 million doses in total.

As a two-dose vaccine, according to the agreement, it could vaccinate up to 50 million people in the UK of around 66 million people.

In a statement on Monday, the UK government said there are now more than half a million doses available, “with an additional ten million doses to be delivered over the coming weeks and months once batches have been quality checked by the MHRA.”

The Oxford AstraZeneca vaccine complements a Covid-19 vaccination program launched by the UK back in December, when the Pfizer BioNTech vaccine launched with two doses. According to the government, more than a million people in the UK have already been vaccinated with the Pfizer shot. It was announced on Monday that more than 730 vaccination sites have been set up across the UK and that hundreds more will be opening this week.

As with the Pfizer vaccine, the Oxford-AstraZeneca shot will be introduced first for priority groups, including residents and employees of nursing homes, people over 80 and health and care workers, and then for the rest of the population in order of age and risk, including those who are extremely clinically vulnerable.

“Decisive moment”

UK Health Secretary Matt Hancock said: “This is a pivotal moment in our fight against this terrible virus and I hope it gives everyone renewed hope that the end of this pandemic is in sight”.

Another vaccine may not come early enough for the UK, which is grappling with an increase in infections, largely due to a mutation in the virus that is making it easier to spread. Britain has now registered over 2.6 million cases of the virus and over 75,000 deaths, according to a record by Johns Hopkins University.

British Prime Minister Boris Johnson said Sunday that further restrictions on public life were likely as Covid-19 cases continue to rise.

On Monday, Hancock told Sky News that the UK cannot roll out the vaccine any faster than supply allows. However, experts agree that the UK needs to step up its vaccination program as soon as possible. Last week, a study by the London School of Hygiene and Tropical Medicine concluded that the UK must vaccinate two million people a week to avoid a third wave of the coronavirus outbreak.

On Saturday, The Times newspaper anonymously quoted a “key member of the Oxford AstraZeneca team” as saying the drug company would increase production so that it would produce two million pounds each week by mid-January.

This goal is achievable, but challenging, says Dr. Andrew Freedman, Infectious Disease Reader at Cardiff University School of Medicine. He told CNBC on Monday that the speed of the rollout will depend on “the availability of the vaccine, vaccine production, but also its distribution and establishment of new vaccination centers and the recruitment of new vaccines”.

“It’s a goal, but it’s realistic and I think it can be achieved by the end of the month,” he told CNBC’s Squawk Box Europe.

The most vulnerable are first vaccinated with shots initially taken in hospitals before the bulk of the shipments are sent to hundreds of doctor’s offices and nursing homes later in the week.

Somewhat controversial, the MHRA, the Joint Committee on Vaccination and Immunization (JCVI) and the UK’s four chief medical officers agreed to move the gap between the first and second dose of coronavirus vaccines that are now being given to the public . The change in strategy was to get most people protected in no time.

The British Medical Association said the decision to postpone the post-dose of the Pfizer vaccine and to cancel appointments for patients who had already been given the second dose was “grossly unfair” for thousands of high-risk patients. However, experts like Freedman said that with a vaccine like the Oxford-AstraZeneca candidate, a longer gap between doses could increase the effectiveness of the sting.

The government last week insisted that “the priority should be to give as many people in risk groups as possible their first dose, rather than delivering the required two doses in as short a time as possible”.

“Everyone will continue to receive their second dose within 12 weeks of the first. The second dose completes the course and is important for longer term protection,” he added.