fbpx

Pfizer bids FDA for FOURTH dose of COVID-19 vaccine in Americans aged 65 and older –

Pfizer has submitted data to the Food and Drug Administration (FDA) to begin distributing the fourth dose of its COVID-19 vaccine to Americans aged 65 and over.

The Washington Post reported that the company submitted data to regulators Tuesday for its inclusion, a joint project with German firm BioNTech.

A fourth shoot has been proposed for months, and Pfizer CEO Albert Bourla announced on a TV show last week that his company will soon be bidding on a fourth shoot.

While the initial authorization only applies to older Americans, it will open the door for a fourth enrollment to be made available to all American adults at some point this year.

The Post also reports that authorization could come as early as Tuesday.

Pfizer files with FDA for fourth dose of COVID-19 vaccine for Americans 65 and older (archive photo)

Vaccination rates were very high among Americans over 65, and nearly all older Americans received at least one injection, according to data from the CDC.  Pictured: A man receives an injection of a COVID-19 vaccine in New York City, New York

Vaccination rates were very high among Americans over 65, and nearly all older Americans received at least one injection, according to data from the CDC. Pictured: A man receives an injection of a COVID-19 vaccine in New York City, New York

Currently, all Americans aged 12 years and older are licensed and recommended to receive a COVID-19 booster vaccine under FDA guidelines.

The Centers for Disease Control and Prevention (CDC) also recommends that immunocompromised Americans take a second booster; this will be the fourth dose for the vast majority of Americans taking one of the two dose vaccine regimens, Pfizer or Moderna-jabs.

However, older Americans are also at significant risk for the virus, and being over 65 is considered a risk factor by health authorities.

With the CDC reporting that nearly all Americans aged 65 and over have received at least one dose of the COVID-19 vaccine, the age group was also willing to receive the injection.

“As we see, now you need a fourth booster,” Bourla told CBS. Challenge the nation on the weekend.

“The protection you get from third parties is good enough, actually good enough for hospitalizations and deaths… not so good against infections, but it won’t last long.”

Pfizer reportedly included data from Israel as part of the package sent to regulators on Tuesday, as the Middle Eastern nation is one of the few countries in the world where older residents can already receive a second dose of supplements.

It’s unlikely that the FDA will need an external meeting panel to discuss the matter, and the agency may even give the green light for additional participation once the data is presented the same day.

Health experts warned that more Covid cases are on the way and could remain a fixture in people’s lives for years to come.

While the mRNA vaccines produced by Pfizer and Moderna are not only safe but also the most effective Covid injections on the market, they are not very durable.

Data from last year showed that protection against infection decreased after just five to six months in people who received their first two-dose set of vaccines.

The protection provided by booster doses is believed to decrease after three to four months, creating the need for quartiles.

However, not all health officials agree that a strategy of repeated supplements to control the virus is the right way to fight the pandemic.

Programmatic considerations, including short- and medium-term delivery of available vaccines, the need for equitable access to vaccines in all countries to meet global public health goals, vaccine demand and the evolution of the virus, a strategy based on repeated booster doses vaccination A working group of the World Health Organization (WHO) “The original vaccine formulation is unlikely to be viable or sustainable,” he said in January.

Pfizer CEO Albert Bourla (pictured) said over the weekend that it is mandatory for Americans to receive the fourth dose of the COVID-19 vaccine.

Pfizer CEO Albert Bourla (pictured) said over the weekend that it is mandatory for Americans to receive the fourth dose of the COVID-19 vaccine.

Criticizing big pharmaceutical companies like New York-based Pfizer during the launch of the injections, WHO wants the company to focus on developing more durable injections rather than releasing boosters over and over in the future.

While Israelis and soon Americans and others in the developed world will have access to the fourth dose, many people in developing countries and especially Africa have not yet accessed the original vaccine regimen.

Alex Maitland, senior adviser at Oxfam, a UK-based anti-poverty nonprofit, called it “skipping the line” in an interview with DailyMail.com earlier this month.

America and other rich countries are repeatedly buying Covid hits and distributing them to their populations.

Meanwhile, the virus will continue to spread overseas, creating more variants.

However, developed countries can always simply buy more hits, limiting the impact of new tensions on them and outpacing developing countries.

However, there isn’t much incentive for Pfizer to abandon this strategy. The company expects revenue of $32 billion from vaccine sales this year alone, and the previously unknown BioNTech has grown into one of the largest companies in the German economy.

A fourth hit, approved this year and purchased by the US government along with others, will only generate more revenue for the pharma giant.

Bourla said on television that filming would need to be done over the next decade to contain the virus.

Many health experts predict that Covid will enter an endemic stage in the coming months, allowing people to live with the virus in much the same way they live with the flu.

Dr. CDC director Rochelle Walensky said earlier this month that she believes the virus will be seasonal, just like the flu, with cases occurring annually in the fall and winter.

Like the flu, an endemic Covid will likely mean that an annual Covid vaccine will be needed, with a new strain likely to emerge and take over each year.

Stephane Bancel, CEO of Moderna, Pfizer’s biggest competitor in the rollout of COVID-19 vaccines, said earlier this year that a fourth vaccine would also be needed, but predicted it would arrive this fall this season.

Moderna is also working on a combined flu and Covid vaccine that people can get in one go.

Source: Daily Mail

Leave a Reply

Your email address will not be published. Required fields are marked *

Top Trending

Related POSTS