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BioNTech, Pfizer Covid Vaccine Will Seek FDA Approval

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Covid-19 vaccine jointly developed by Pfizer-Pfizer Covid Vaccine-ss-featured

The BioNTech and Pfizer Covid Vaccine will seek FDA approval by Friday this week. The vaccine, developed with German company BioNTech, reported a 95% effectiveness rate in preventing coronavirus among 44,000 participants. 

RELATED: How Much Will Coronavirus Vaccines Cost the US Taxpayer?

The companies said they will ask the Food and Drug Administration (FDA) to provide emergency use authorization within the next few days. Accordingly, this means the vaccine can still proceed with distribution within the year. Specifically, expect the first few million doses of the vaccine available for those who need them the most. 

95% Effectivity Rate

Pfizer and BioNTech’s BNT162b2 vaccine requires 2 doses taken three weeks apart. In fact, the full effect takes place 28 days after the first dose. The final lab results report that the effectiveness remained consistent across all ages, races, and ethnicities. Additionally, the vaccine provided 94% effectiveness among the elderly. These are among the high-risk groups for Covid-19.  

BioNTech CEO Ugur Sahin said that “The final analysis underlines the results of the positive interim efficacy analysis announced on November 9. The data indicates that our vaccine…is able to induce a high rate of protection against COVID-19 only 29 days after the first dose. In addition, the vaccine was observed to be well-tolerated in all age groups with mostly mild to moderate side effects, which may be due in part to the relatively low dose.”

No Serious Effects

Seemingly, Pfizer and BioNTech’s vaccine prevents severe disease in volunteers. Nine of the ten participants that developed severe cases of Covid belonged to the placebo group. The trial did not report any serious safety concerns. They also reported that most adverse events resolved themselves shortly after vaccination.

Among the side effects reported was fatigue, as 3.7% of volunteers reported tiredness after taking the second dose.  Additionally, 2% percent of participants reported a headache after the second dose. 

Equally Effective for Older People

Meanwhile, older adults reported fewer and milder side effects. Sahin said that enough older adults joined the study, which made them more susceptible to infection. He is very optimistic that “this vaccine appears to work in the higher-risk population.”

Yale Iwasaki, Yale University immunologist finds the results “pretty amazing.” She remarked that the vaccine’s effectiveness in people over 65 offers the most promise. “We know from the influenza vaccine that it’s very difficult to achieve protection in this age group with vaccines,” said. A 94% success rate among this group “is really remarkable.” 

How Many Will Be Available by 2020? 

The US Human and Health Services secured a $2 billion deal with Pfizer to get 100 million doses as soon as they receive approval. For 2020, Pfizer plans to produce up to 50 million doses. Half of this will head straight to the US as part of their deal. With the vaccination requiring two doses, the HHS would have 25 million doses available. Therefore, the supply will cover up to 12.5 million Americans by December. Subsequently, Pfizer will deliver the remaining balance by next year. 

Another company, Moderna Inc, also came up with a potential vaccine that might be ready by December. The company also reported a 94.5% effective rate during their late-stage trials. Previously, HHS also signed a pre-order for 100 million doses from Moderna for $1.5 billion. Then, if Moderna pans out later this month, the US can get supplies for at least another 12.5 million Americans. 

Who Gets the Vaccines First? 

Assuming Pfizer or any other company receives emergency approval, the US is now gearing for distribution. The Advisory Committee on Immunization Practices will vote on who gets the first few batches. Experts believe doctors, nurses, and other health workers treating Covid-19 patients should have first priority. The committee recommended that people with a high risk of contracting Covid-19 should get the next priority. Elderly people, especially those in nursing homes, and people in prison should follow next. Next, teachers and transportation workers to help them conduct their jobs safer.

Pharmaceutical analyst Ronny Gal of Sanford C. Bernstein thinks herd immunity can happen by next year. He said in a research note Tuesday that vaccination in the U.S. would occur quickly and the country would achieve herd immunity by June. Resistance to the vaccine would drop if the vaccine showed highly effective results, Gal said.

Unanswered Questions

Dr. Saad B. Omer, Yale Institute for Global Health director, noted that the first goal should aim to prevent people from becoming extremely ill. There are not enough doses to stop the spread of infections. He called on Pfizer to quickly release more details on their data. Pfizer and BioNTech planned to submit results for review in a scientific journal. “These are not normal times, this is a pandemic, and major policy is being made,” Dr. Omer said. “It’s always better to make policy on scientific data, not a press release.”

How long the vaccine protection lasts remains unknown. Pfizer will need two years of research to make a detailed assessment. Also, the data does not reflect vaccine effectiveness in children and young adults below 18 years old. However, Pfizer started adding children as young as 12 in its ongoing trial. 

Great Timing

The accelerated progress of the BioNTech and Pfizer Covid vaccine is welcome news. Presently, the United States is currently experiencing a resurgence of the virus, infecting over 155,000 a day. The daily death toll is at least 1,700 patients. With winter approaching, things may go from bad to worse. Even if the initial delivery would only cover a few million Americans, the vaccines can help protect the most vulnerable.

Watch this, CNN: Pfizer reports Covid-19 vaccine is 95% effective

With a limited supply of BioNTech and Pfizer Covid vaccines to be made available this year, who should get the first doses?

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With a projected, 25 million doses for 12.5 million Americans, who do you think should get priority? Let us know what you think by sharing your experiences with Covid-19 in the comment section below.

4 Comments

4 Comments

  • Avatar Anonymous says:

    All gov official pelosi frist Dr fousi ,Biden all Sen, congress, govenors and so on

  • Avatar Phil H Meloon says:

    Pelosi and elected officials LAST.

  • Avatar Jake says:

    I believe that all front line workers and anyone 65 and higher should get it first…the front line workers are a given but anyone that is 65 and older is too because they are at a higher risk and they, along with the front line workers are the people following the rules about mask, social distancing, etc. also, those at high risk because of health issues, no matter their age, should be next

  • Avatar Anonymous says:

    I’m concerned about ingredients, long term effects etc. when will they let the public know what they are going to be taking? I’ve heard some disturbing information about some of the contents. I for one, will not take it! I don’t trust what is going on with our government right now, at all. I do however worry about my children and grandchildren. To answer the question, frontline workers, high risk individuals and so on.

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