Vaccine-dosing debates develop as New York discovers COVID-19 virus variant case

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NEW YORK (NewsNation Now) – New York State confirmed its first case of the new variant of coronavirus in a 60-year-old man with no known travel history on Monday. The discovery adds a new urgency as the Empire State works to vaccinate its 20 million residents.

Those efforts are falling behind, fueling a debate that governments around the world are having: should they focus on firing a shot or two?

Given Operation Warp Speed’s less rapid vaccine rollout, some experts are suggesting delaying the booster and giving a single dose to as many arms as possible to give more Americans at least some level of immunity. Depending on the study, this level looks quite acceptable.

UK regulators believe a single shot of the Moderna vaccine is 80 to 90% effective and say the Pfizer / BioNTech shot is 70% effective after one dose and 95% effective after two.

Other experts argue that the data may be incomplete because it is a novel virus that is being attacked with new drugs.

“If suddenly I was told, ‘You’re going to get half a dose,’ I’d scratch my head and wonder why that has changed,” said Dr. Joseph Gastaldo of OhioHealth told NewsNation subsidiary WCMH.

On Monday evening, the Food and Drug Administration released a statement on compliance with the legal dosage and schedule for COVID-19 vaccines:

“Two different mRNA vaccines have now shown remarkable effectiveness of around 95% in preventing COVID-19 infection in adults. As the first round of vaccine recipients are eligible to receive their second dose, we want to remind the public of the importance of receiving COVID-19 vaccines based on how they have been approved by the FDA to ensure the level of protection get observed in the large randomized trials that support their effectiveness.

We have followed the discussions and news reports about reducing the number of doses, increasing the time between doses, changing the dose (half dose), or mixing and matching vaccines to immunize more people against COVID-19. These are all reasonable questions to consider and evaluate in clinical trials. At this time, however, it is premature to propose changes to the FDA-approved dosage or schedules of these vaccines, and they are not firmly anchored in the available evidence. Without adequate data to support such changes in vaccine administration, there is a significant risk of public health threats, undermining historical vaccination efforts to protect the population from COVID-19.

The data available continue to support the use of two set doses of each approved vaccine at set intervals. For the Pfizer-BioNTech COVID-19 vaccine, the interval between the first and second dose is 21 days. And for the Moderna COVID-19 vaccine, the interval between the first and second dose is 28 days.

What we have seen is that the data in the companies’ submission regarding the first dose is often misinterpreted. In the phase 3 studies, 98% of the participants in the Pfizer BioNTech study and 92% of the participants in the Moderna study received two doses of vaccine three and four weeks apart. Those participants who received two doses of vaccine neither three nor four weeks apart were generally only observed for a short period of time, so that after a single vaccine dose we cannot make any definitive conclusions about the depth or duration of protection from those provided by the Company reported single dose percentages.

Using a single dose regimen and / or administering less than the dose studied in the clinical trials without understanding the nature of the depth and duration of protection is important as there is evidence to suggest that the depth of the immune response is related the duration of protection. When people don’t really know how protective a vaccine is, they run the risk of harm as they can assume they are fully protected if they don’t and change their behavior accordingly to take unnecessary risks.

We know that some of these discussions about changing the dosing schedule or dosage are based on the belief that changing the dose or dosing schedule can help more vaccines get to the public faster. However, such changes, which are not supported by adequate scientific evidence, can ultimately be counterproductive to public health.

We have consistently committed to making decisions based on data and science. Until vaccine manufacturers have data and scientific evidence to support a change, we strongly encourage healthcare providers to continue to adhere to the FDA-approved dosing schedule for any COVID-19 vaccine.

The FDA, an agency of the US Department of Health, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety of our country’s food supplies, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products. “

Dr. STEPHEN M. HAHN, FOOD AND DRUG COMMISSIONER – FDA
– Dr. PETER MARKS, DIRECTOR’S CENTER FOR BIOLOGICAL EVALUATION AND RESEARCH (CBER)

NewsNation’s Marni Hughes speaks to a leading expert on coronavirus vaccines, Dr. Steven Thomas, of Upstate University Hospital in NEW YORK

At the Long Island Jewish Medical Center in Queens, intensive care nurse Sandra Lindsay, the first in America to receive the COVID-19 vaccine, was among the first to be fully vaccinated. She got her second dose on Monday.

“I know we’re not out of the woods yet – we don’t have herd immunity yet, but the burden definitely feels much lighter today,” said Sandra Lindsay.

The first person in the US to receive a coronavirus vaccine will receive the final dose

As in major cities around the world, concerns are growing in New York over the relatively small number of people who received their first dose of the COVID-19 vaccine. A little over 100,000 in a city of 8 million people.

The initial rollout was slow as health care workers became familiar with the storage and management of recordings. The mayor of the city says the time for training is over.

“Now – from that point on – 7 days a week, 24/7 has to be the attitude and the approach,” said Bill De Blasio.

As the UK works to give more people a single dose, it relies to some extent on science that is not yet complete, which worries America’s leading infectious disease experts.

Dr. Anthony Fauci told NBC’s Face the Nation on Sunday that the stakes were too high not to stick to the plan.

“Go into the trenches, go to the hospitals, go to the intensive care units and see what happens. These are real numbers, real people and real deaths, ”said Dr. Fauci.

Over the weekend, New York state passed 1 million confirmed coronavirus cases – the fourth state to hit that milestone after Texas, California and Florida, according to Johns Hopkins.

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