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Pfizer, Moderna Release Data Supporting Booster Shot

Booster shot
Both Pfizer and Moderna backed up their previous research on Wednesday as they reiterated the need for a booster shot. Credit: Marco Verch CC By SA 2.0

Late on Wednesday, the pharmaceutical firm Moderna released new data regarding breakthrough cases of the coronavirus that it says supports the need for a third booster shot of its coronavirus vaccine.

Earlier the Pfizer Corporation had announced that evidence from Israel shows a third coronavirus vaccine shot restores protection back up to the original effectiveness rate of 95% as it made the case to the US Food and Drug Administration for boosters.

Pfizer stated that the need for the authorization of a booster shot is in response to what it called an “urgent emerging public health issue” as the much more contagious Delta variant of the virus races across the globe.

Adding further assurance to those who may shun the third shot for fear of additional side effects, Pfizer officials stated that such occurrences are similar to those observed after receiving the second dose of the vaccine.

For its part, Moderna officials offered up a new analysis that showed breakthrough Coronavirus cases were experienced less often in those who were more recently vaccinated, indicating that the effectiveness of the shot does indeed wane over time.

The Cambridge, Massachusetts firm noted that analysis gleaned from its phase three study showed the incidence of breakthrough cases in fully vaccinated people, occurred less often in a group of trial volunteers who had been inoculated recently, suggesting that immunity for those who received the coronavirus vaccines has begun to wane.

In all, Moderna cited a total of 88 known breakthrough cases out of 11,431 individuals who had been vaccinated between December of 2020 and March of 2021, compared with 162 such cases out of a total of 14,746 trial subjects who had received their inoculations in July through October of 2020.

The pharmaceuticals firm also announced in the statement that fewer severe cases of the coronavirus occurred in those who had received the vaccine more recently, according to a manuscript of the results distributed by Moderna.

Vaccine booster shot decision as Delta variant rages

There were only three coronavirus-related hospitalizations that occurred in those who had received their inoculations early on, and these resulted in two deaths, according to Moderna officials.

There were no hospitalizations or deaths at all for those who had received a more recent shot, although the firm said that this finding regarding severe cases was not considered statistically significant.

CNBC reported Moderna President Stephen Hoge said in an interview “There’s a large debate, we all know, about whether or not vaccine boosters are going to be necessary into the fall.

“That debate, what makes it really hard is it’s not really about whether the vaccine worked last month. It’s really about whether it’s going to work this winter.”

Vital FDA outside panel meeting set for Friday

Meanwhile, FDA officials declined earlier on Wednesday to endorse any position regarding Pfizer’s third shots, saying that there is a lack of verified data at this point.

As of now, there has been no peer review of the Moderna analysis.

The new flurry of vaccine claims appeared on the scene just two days before an important FDA vaccine advisory committee meeting; this initial panel of outside experts is tasked with debating whether or not there is enough evidence to support the wide distribution of booster shots across the country.

This advisory group, the Vaccines and Related Biological Products Advisory Committee, was also the first body to consider the first coronavirus vaccine to come on the market in November of last year. Now it will debate the administration of a third dose of  the Pfizer/BioNTech product.

Federal health regulators have stated that they need more time to review the equivalent information regarding the Moderna booster shot.

Moderna president Hoge stated the data indicated that “we do see a significant increase in the risk of Covid-19 for those who are vaccinated a year ago versus six months ago.

“If you take that number, which in the paper is roughly 28 cases per 1,000 persons, and you extrapolate that across the 60 million Americans who’ve received that vaccine, the incremental number of cases of Covid-19 that would happen between here and the hospitals is about 600,000, more than half a million cases of Covid-19,” he explained.

Biden administration behind booster program early on

Observers noted that the FDA may be looking askance at some of the information provided by Pfizer, including the numbers on vaccine efficacy from Israel, where researchers there have shown that indeed the Pfizer shot’s protection does indeed wane over months’ time.

The urgency of the Winter setting in as the Delta variant continues to march across American society makes for a fraught meeting for the panel on Friday.

Biden administration officials have already said it would like to begin to offer booster shots to all those who are eligible as early as next week, as long as the FDA signs of on a third inoculation. The President has been dogged by lingering economic and social issues as the variant makes hospitals fill up across the nation just as children return to school this Fall.

The administration already shared the results of three studies, which were released by the Centers for Disease Control and Prevention, indicating that the vaccines’ protection did indeed decrease over the course of several months.

The White House’s plan, frequently bruited about by many in the ongoing debate on booster shots, calls for the general public to receive a third inoculation eight months after completion of their Pfizer or Moderna vaccine series.

Immunocompromised individuals already have third shot

Some immunocompromised individuals in the US — as well as many Israeli citizens — have already received their third shot, exactly eight months after their second dose.

However, some scientists have criticized this practice, saying that the data used by the federal health officials wasn’t convincing enough, even going so far as to state that the Biden administration’s emphasis on starting a booster program was premature.

Earlier this week, the British medical journal The Lancet published a scientific paper written by a leading group of scientists positing that booster shots are not needed now for the general public. Their position was that even though the protection afforded by inoculations does indeed decrease over time, their effectiveness against severe disease seems to persist.

The scientists — including two senior FDA officials and a number of scientists from the World Health Organization (WHO) called the distribution of booster shots to the general public “not appropriate” at this time.

Earlier this year, as the vaccination campaigns across the developed world reached a saturation point, with nearly all who were willing to receive a vaccine being fully inoculated, WHO chief Tedros Adhanom Ghebreyesus warned wealthier nations that there should be no question of administering booster shots while people in developing nations still had not received a first shot.

Bourla announces children’s shot info before FDA imminently

Pfizer CEO Albert Bourla also stated on Tuesday that coronavirus vaccine data for children under the age of five may become available as early as late October.

The Thessaloniki-born Pharma CEO said that he expects to release the official clinical trial data on its vaccine for children between the ages of six months to five years by the end of October.

Meanwhile, the data concerning children between five and eleven years of age will become available much sooner — possibly allowing Pfizer to submit it to the FDA by the end of September.

“Then, it is up to the FDA to take their time, and then make a decision,” Bourla stated in an interview at Research!America’s 2021 National Health Research Forum.

Bourla’s encouraging news comes at a time when children across the country are returning to school, with some of them testing positive despite the strict coronavirus measures, including masking and social distancing, taken across the board nationwide.

Many parents are anxious to have their children vaccinated, especially as the much more infectious Delta variant is continuing to pose a problem across the country. This mutation of the virus has been responsible for a spike in hospitalizations across the U.S., even for young children.

Although they do not suffer from the most severe form of the virus as a rule, compared to adults, the lack of a vaccine for younger children has occasioned ongoing worry for parents, educators and school officials.

 

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