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Not prudent to deploy vaccine boosters at this level: Ex-FDA director

Not prudent to deploy vaccine boosters at this point: Ex-FDA director

There is currently insufficient evidence that Covid vaccine booster shots are required, according to a former FDA director.

“It is a good thing to be prepared to make boosters, but we really don’t have … evidence, at least in the United States, where we’re seeing vaccine failures or a decrease in immunity, so it’s time to put a booster on “said Norman Baylor, who previously worked for the US Food and Drug Administration’s Vaccine Research and Review Bureau.

Pharmaceutical company Pfizer is developing a Covid booster, or third dose, to combat the highly transmissible Delta variant, which has become the dominant strain in many countries, including the United States

The Centers for Disease Control and Prevention and the FDA said in a joint statement last week that “Americans who have been fully vaccinated currently do not need a booster dose”.

Pfizer met with U.S. officials Monday to plead for a third shot.

The company worked with German company BioNTech to develop a vaccine consisting of two doses given three weeks apart. In December it received emergency approval from the World Health Organization.

No significant vaccination failure

The vaccine errors are currently very small with the vaccines currently in use. Until that changes, I don’t think it would be advisable to give a booster dose.

Norman Baylor

CEO of Biologics Consulting

Westbury, NY: A man receives the Moderna COVID-19 vaccine while at the Long Island State Qualified Health Center in Westbury, New York on April 29, 2021. (Photo by Steve Pfost / Newsday via Getty Images)

Steve Pfost | News day | Getty Images

He said health officials seem to agree that a third dose is not required.

“We’re just not there yet … we have no evidence that it is time to get a booster,” he said, adding that there may be new variations in the future that make current vaccines ineffective or much less effective.

Vaccination inequality

Richer countries have been able to vaccinate a large part of their population, while poorer countries lag behind.

The issue of vaccine disparity between regions needs to be addressed, Baylor said.

“A pandemic itself, the definition is that it is global,” he said, adding that he agreed with the World Health Organization that the crisis must be viewed from a global perspective.

Some countries and regions are actually ordering millions of booster doses before other countries have had supplies to vaccinate their health workers and those most at risk.

Tedros Adhanom Ghebreyesus

Director General, World Health Organization

WHO director general Tedros Adhanom Ghebreyesus said Monday the world is “in the midst of a growing two-pronged pandemic”.

“Some countries and regions are actually ordering millions of booster doses before other countries have had supplies to vaccinate their health workers and the most vulnerable,” he said during a press conference, adding that the world Make “conscious choices” so as not to protect those most in need.

The data suggest the vaccines offer long-lasting immunity to severe and deadly Covid-19, he said.

“The priority now must be to vaccinate those who have received no doses and no protection,” said the WHO chief.

Biotech companies such as Pfizer-BioNTech and Moderna, which have developed another mRNA vaccine against Covid-19, must “give everything” to direct supply to the places in need, including through the Covax vaccine distribution alliance, he added.

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‘Dangerous’ to delay second Covid vaccine photographs within the UK: ex-FDA director

'Risky' to delay second Covid vaccine shots in the UK: ex-FDA director

Postponing the second dose of Covid-19 vaccines is “very risky” because the efficacy data was based on a specific dosage schedule, a former FDA director told CNBC on Thursday.

His comments came after the UK’s decision to give a second shot of the coronavirus vaccine 12 weeks after the first dose, contrary to vaccine manufacturers’ recommendations. Germany is reportedly considering a similar move, while Denmark approves a six-week gap between doses.

The vaccines approved for use in the UK both require two doses.

American pharmaceutical company Pfizer and German biotechnology company BioNTech recommended giving the second dose of their vaccine 21 days after the first. British-Swedish pharmaceutical company AstraZeneca said the vaccine, jointly developed with Oxford, requires two doses to be given one month apart. The UK initially said it would follow this timetable.

It’s a very risky endeavor because if it fails, you will be worse off.

Norman Baylor

Former FDA director

Any decision to change dosing schedules should be based on data, said Norman Baylor, a former director in the US Food and Drug Administration’s bureau of vaccine research and testing.

“It is very risky to try to extend [the gap between two doses] or give a dose if there is no data, “he told CNBC’s Street Signs Asia on Thursday.

“I can see some reasons for this, but again, it’s not really data-driven,” said Baylor, who is also president and chief executive officer of Biologics Consulting. “It’s a very risky endeavor because if it fails, you will be worse.”

The UK’s controversial decision came as the country continued to grapple with a new strain of the coronavirus that is spreading faster, despite no evidence that it is more severe or deadly. 62,322 cases were reported on Wednesday, and more than 2.8 million people have tested positive for the virus to date, according to government figures.

A nurse prepares the Oxford-AstraZeneca vaccine at Pontcae medical practice in Merthyr Tydfil, Wales on January 4, 2021.

Matthew Horwood | Getty Images News | Getty Images

Delaying the second dose of the vaccine means more people can get their first dose. However, Baylor said it was ideal to follow the dosing regimen from the vaccine’s effectiveness studies.

“If you don’t have the data, you are taking a risk there,” he said. “That is the point, the risk you are taking.”

Weigh vaccine manufacturers

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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.”