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UK choice to delay second Covid vaccine shot endorsed by advisors

West Virginia mistakenly gives 42 people Regeneron IV Covid treatment instead of vaccine shot

A pharmacist dilutes the Pfizer COVID-19 vaccine as he prepares it for administration to staff and residents at Goodwin House Bailey’s Crossroads, a senior community in Falls Church, Virginia, on December 30, 2020.

Brendan Smialowski | AFP | Getty Images

LONDON – Health experts have condemned the UK’s decision to delay the administration of a second dose of the coronavirus vaccine developed by Pfizer and BioNTech, warning that the need to suppress the new strain of coronavirus “cannot be overstated “.

Shortly after the UK announced that the second dose of the Pfizer BioNTech jab, in addition to the newly approved Covid-19 vaccine developed by AstraZeneca and the University of Oxford, will now be given up to 12 weeks after the first dose.

The National Health Service had previously planned to give a second dose of the Covid-19 vaccine three weeks after the first to ensure a high level of protection against the virus.

The UK’s Independent Scientific Advisory Group on Emergencies (SAGE) said in a statement released on Sunday that it was “a very difficult and balanced decision” but was in favor of the UK government’s move to cover as high a proportion of the population as possible.

However, the change in policy would have to go hand in hand with several other measures. These included: publishing a detailed and compelling strategy to scale up vaccination, developing a rigorous assessment process, real-time assessment of ongoing virus variation, and the need to restrict movement to and from the UK to the rest of the world.

SAGE is made up of health professionals and scientists and is jointly managed by the UK Government’s Chief Scientific Advisor and Chief Medical Officer.

Meghana Pandit, Chief Medical Officer of the NHS Trust, Oxford University, right, speaks to Trevor Cowlett, 88, before receiving the Oxford University AstraZeneca Plc and Covid-19 vaccine at Churchill Hospital in Oxford, UK on Monday. January 4, 2021. UK regulators approved the shot last week, giving it its first approval anywhere in the world.

Steve Parsons | PA wire | Bloomberg | Getty Images

The comments come despite the British Medical Association criticizing the UK’s decision to postpone the second dose of Pfizer BioNTech vaccine. It described the move as “grossly unfair” to thousands of high-risk patients in England.

“The BMA is of the opinion that the existing commitment of the NHS and local doctors to these patients should be respected. If the GPs decide to keep these booked appointments in January, the BMA will support them,” said Dr. Richard Vautre, Chairman of the BMA GP Committee. said in a statement on December 31.

In response to these concerns, the SAGE Committee said, “Under normal circumstances, we would advocate continuing our previous plans of administering two doses of Pfizer BioNTech vaccine 21 days apart. However, these are not normal circumstances and it is are other important public health considerations. “

The German Ministry of Health asked an independent vaccination commission for advice on Monday whether it should follow in the UK’s footsteps.

A ministry spokesman confirmed to CNBC that the federal government had asked the Robert Koch Institute’s Standing Committee on Vaccination if the country should delay a second vaccination with the Pfizer vaccine. “Such a decision requires scientific consideration,” they added.

“Hard” measures required

British Prime Minister Boris Johnson said Monday the government could soon announce stricter public health measures to prevent the coronavirus from spreading.

Johnson said “tough” measures could come for weeks. Currently, more than three quarters of the UK population is in Tier 4 – the highest level of restrictions.

The opposition Labor Party said the government must impose a national lockdown within 24 hours and warned the virus was “clearly out of control”.

The UK recorded more than 50,000 new confirmed Covid-19 infections for the sixth consecutive year on Sunday. The country continues to fight a new strain of the virus that is spreading faster.

To date, the UK has reported more than 2.6 million coronavirus cases with 75,137 deaths, according to Johns Hopkins University.

“It is now clear that the new variant of the virus that appears to have surfaced in south-east England is 40-80% significantly more transmissible than previous variants,” SAGE said in a Jan. 3 statement.

“It is also clear that the current Tier 4 restrictions cannot contain their spread even if schools and universities are closed.”

“The pandemic is now out of control and the NHS is struggling with some hospitals being forced to cease non-COVID activity. The NHS is no longer protected. For these reasons, there is a strong case for maximizing population coverage with at least one dose of vaccine although this requires a change in the dosage regimen, “added the group.

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U.S. may ramp up sluggish Covid vaccinations by giving two half doses of Moderna shot

New York Mayor de Blasio wants to immunize 1 million residents in January

A FDNY EMS Fire Department employee receives a COVID-19 Moderna vaccine amid the coronavirus disease (COVID-19) pandemic in the Manhattan neighborhood of New York City, New York, United States. December 23, 2020.

Carlo Allegri | Reuters

The head of the federal government’s Covid-19 vaccination program said Sunday that health officials are considering the idea of ​​giving a large group of Americans half-volume doses of a vaccine to speed up adoption.

Moncef Slaoui, head of Operation Warp Speed, said on CBS’s “Face the Nation” that one way to speed up immunization against Covid-19 is to give some people two half-volume doses of the Moderna vaccine.

“We know that for the Moderna vaccine, half the dose is given to people between the ages of 18 and 55 – two doses, half the dose, which is exactly the goal of getting twice the number of people using the doses immunize that we have – we know it induces an identical immune response to the 100 microgram dose, “Slaoui said.

“And that’s why we’re in talks with Moderna and the FDA – of course it will ultimately be a decision of the FDA – to accelerate the injection of half the volume,” he added.

Moncef Slaoui, a former executive director of GlaxoSmithKline, speaks to President Donald J. Trump during a vaccine development event in the Rose Garden of the White House on Friday, May 15, 2020 in Washington, DC.

Jabin Botsford | The Washington Post | Getty Images

The comments came in response to why the US is not adopting the strategy of giving all available vaccine doses now, even though the approved vaccines require a second round of firing to be fully effective. The UK has taken this approach in the hope that continued production will enable the second recordings in the future.

Slaoui said it was a mistake to make a decision that was not supported by the experimental data. White House Health Advisor Dr. Anthony Fauci, commented similarly on NBC’s Meet the Press on Sunday, said the strategy “goes against science” and would not solve the problems with the US launch.

“The idea of ​​expanding it so you can get more people is when you don’t have enough vaccine and a lot of people are waiting in line to wait for a vaccine,” Fauci said. “That’s not our problem now. We have a vaccine. We have to get it into people’s arms. It really is the right solution to the wrong problem.”

The FDA and Moderna did not immediately respond to requests for comment.

The dispute over different vaccination approaches stems from the fact that the introduction of the vaccine in the US did not achieve the goals of Operation Warp Speed ​​and the pandemic continues to devastate the country. President Donald Trump has blamed states for the slow adoption as the number of vaccinations given lags behind the number of vaccines sent and delivered.

Health officials wanted to inject a vaccine to 20 million Americans by the end of the year. However, according to the Centers for Disease Control and Prevention, only about 4.2 million people had received gunfire by January 2.

The last 7-day average for new cases of the coronavirus in the US is 205,093, according to John Hopkins University. That number has grown by 8% week-to-week, although tests and reports tended to be inconsistent during the holiday season. According to Johns Hopkins, the nation has an average of more than 2,600 deaths a day attributed to the virus.

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Health

West Virginia mistakenly provides 42 individuals Regeneron IV Covid therapy as a substitute of vaccine shot

West Virginia mistakenly gives 42 people Regeneron IV Covid treatment instead of vaccine shot

A pharmacist dilutes the Pfizer COVID-19 vaccine as he prepares it for administration to staff and residents at Goodwin House Bailey’s Crossroads, a senior community in Falls Church, Virginia, on December 30, 2020.

Brendan Smialowski | AFP | Getty Images

Dozens of people in West Virginia were mistakenly given Regeneron’s Covid-19 antibodies instead of the Moderna vaccine, the West Virginia National Guard said Thursday.

According to the state’s National Guard, 42 people received the intravenous treatment at a Boone County Department of Health vaccination clinic. The National Guard said it learned of the mistake on Wednesday.

Everyone who received the antibody treatment instead of the vaccine, which is given through a shot in the arm, has been contacted, Julie Miller, a Boone County Health Department administrator, told CNBC via email. She added, “We don’t think there is any risk of harm.”

Regeneron’s monoclonal antibody treatment, which must be given via an IV drip, is seen as a promising treatment for Covid-19 – especially if given early in the course of the infection. But the West Virginia mix-up is just one example of the confusion in the rush to distribute the vaccine to tens of millions of people. The rollout was slower than expected and was characterized by logistical challenges.

“It was determined that this was an isolated incident,” Miller said. “All those affected will be offered the COVID-19 vaccine today.”

She said the health department will work closely with the state National Guard and the Department of Health and Human Resources to review their policies and procedures.

Miller did not provide details on what caused the mix-up.

Representatives from the West Virginia National Guard and the West Virginia Governor’s Office did not respond to CNBC’s request for further comment on the occurrence of the error.

Maj. Gen. James Hoyer, adjutant general of the West Virginia National Guard, said in a statement that his forces “acted immediately” to correct the mistake as soon as they found out what happened. “We immediately reviewed and strengthened our logs to improve our sales process and prevent this from happening again,” he said in a statement.

He added that the state will continue to promote the vaccine “to save more lives every day”.

Dr. Clay Marsh, the state’s Covid-19 tsar, noted in a statement that the Regeneron treatment mistakenly given in place of the vaccine is the same product “that was given to President Trump when he became infected”.

“Although this injection is not harmful, it has replaced the vaccine,” he said. “However, this event provides an important opportunity for our leadership team to review and improve the safety and vaccination process for every West Virginian.”

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Health

Unwanted effects are indicators shot is constructing safety, says ex-FDA chief

Side effects are signs shot is building protection, says ex-FDA chief

Covid-19 vaccine side effects are signs that the shots are helping to protect against the disease, said former FDA chief Dr. Margaret Hamburg on Thursday opposite CNBC.

“The data tell us that this vaccination produces a fairly routine response at the time of administration, but it is noteworthy when you receive the vaccine,” she said on Squawk Box. “You will know when you will receive the vaccine, but that will also show you that it works and that your body is reacting,” added Hamburg, who headed the regulator in the Obama administration from 2009 to 2015.

The Hamburg statements come when the vaccine committee of the Food and Drug Administration meets on Thursday whether Pfizer and German partner BioNTech should vote for the emergency approval of the Covid-19 candidate. The non-binding decision by the panel of experts is a final step before the FDA is expected to approve the vaccine for limited use.

The agency will meet next week at the request of Massachusetts-based Moderna to obtain the same approval. The vaccine is similar to Pfizer’s in that they both take a new approach that uses genetic material to trigger an immune response.

Pfizer’s vaccine was approved by regulators in the UK last week, where the first shots for non-trial participants were given on Tuesday. However, the two allergic reactions reported by UK health workers prompted UK regulators to advise people with a history of “significant” allergic reactions to abstain from the vaccine for the time being.

Coronavirus vaccine development deadlines have been hastened this year by drug makers and governments alike in hopes of finding a solution to the devastating pandemic that killed at least 1,571,890 people worldwide, according to Johns Hopkins University. The US recorded a record 3,124 deaths on Wednesday.

Both Pfizer’s and Moderna’s vaccines were shown to be more than 94% effective in preventing symptomatic Covid-19, according to data from large-scale clinical trials.

Some of the reported side effects are “local swelling, irritation, pain, fatigue, sometimes headache,” said Hamburg. “A percentage of the patients had chills and a slight fever.”

Dr. Moncef Slaoui, who leads the Trump administration’s vaccine development efforts, has defended the safety of Pfizer and Moderna vaccines. He said earlier this month that “significantly noticeable” side effects from the admissions were reported in only 10% to 15% of study participants, which may lasted up to a day and a half.

Both Pfizer’s and Moderna’s vaccines require two doses. Some doctors have tried to raise awareness of the side effects so that vaccine recipients aren’t deterred from getting the second shot.

“We really need to make patients aware that this is not going to be a walk in the park,” said Dr. Sandra Fryhofer of the American Medical Association in November at an advisory panel meeting of the Centers for Disease Control and Prevention. “You will know you had a vaccine. You probably won’t feel wonderful. But you have to come back for that second dose.”