FDA scientists strike favorable tone forward of vote this week

The Janssen Johnson & Johnson COVID-19 vaccine.

Allen J. Cockroaches | Los Angeles Times | Getty Images

The Food and Drug Administration staff adopted a more favorable tone on Wednesday Johnson & Johnson Covid-19 booster vaccination, which states that giving a second dose two months after the first vaccination may be beneficial.

However, staff admitted that data to support boosters was limited and the agency has not yet verified all of the information.

“Although not independently confirmed by the FDA from independent datasets, summaries of the data suggest that a second dose administered approximately 2 months after the primary dose may have a benefit compared to efficacy in the pivotal study COV3001,” they wrote in a 54-page document published on Wednesday.

They also said that a J&J dose was consistently less effective than the Pfizer and Moderna mRNA vaccines in both clinical trials and real-world trials.

“The highest effectiveness estimates (including for more severe COVID-19 illnesses) in clinical trials and real-world effectiveness studies evaluating the Janssen COVID-19 vaccine are consistently below the highest effectiveness estimates for the mRNA COVID-19 vaccines,” they said.

Overall, the data shows that the J&J single-shot vaccine “still offers protection from severe COVID-19 illness and death in the United States”.

The report by FDA scientists is set to brief the agency’s Advisory Committee on Vaccines and Related Biological Products, which will meet on Friday to discuss data on the safety and effectiveness of a second J&J syringe in adults. The published documents give an insight into the agency’s perspective on additional recordings.

Unlike Pfizer and Moderna’s two-step mRNA vaccines, J&J hoped to offer a one-shot solution that would protect the public adequately to contribute to the Coronavirus pandemic. But its 72% protection in the US was viewed by some as inferior to the Moderna and Pfizer vaccines, both of which touted efficacy rates of over 90%.

A second dose of J & J’s Shot provides similar performance to the mRNA vaccines and increases protection against symptomatic infection to 94% when given two months after the first dose in the United States, according to company data released Sept. 21 became. J&J, the a. used modified adenovirus In order to trigger an immune response, the agency asked on October 5 for approval of a booster dose of its single-dose vaccine for people aged 18 and over.

However, in the documents released on Wednesday, FDA scientists suggested that there wasn’t enough data on the elderly or the fast-paced Delta variant to draw any conclusion about the benefits of boosters.

They said the sample size J&J provided for people 60 years and older “limits the possibility of inferring an increase in efficacy after the second dose in this group.”

“Finally, the small number of defendants who have been confirmed to be caused by the Delta variant precludes any conclusion as to effectiveness against the variant,” they added.

Staff said no new safety issues were observed after a second dose given two or three months after the first dose, but noted that it is currently unknown “if after” an increased risk of these or other side effects there is an additional dose.

The FDA advisory group is due to discuss data on the safety and effectiveness of booster vaccinations for Moderna in adults on Thursday and J&J on Friday. The agency could make a final decision within days of the meetings and hand it over to the Centers for Disease Control and Prevention and their Vaccine Advisory Committee, expected to make their own decision next week.

FDA scientist refused to take a stand whether on Tuesday, in an unusual move, booster shots of the Covid vaccine from Moderna will be supported, with the data showing that currently approved vaccines in the US still protect against serious illness and death

Last month, US regulators authorized Covid booster recordings from Pfizer and BioNTechs Vaccine for a wide variety of Americans, including the elderly, adults with pre-existing conditions, and those who work or live in high-risk environments such as health and food workers.

Norman Baylor, former director of the FDA’s vaccines office, said last week that he did not recommend presenting Moderna’s vaccine to an advisory committee because it uses a similar platform to Pfizer’s vaccination, which has already been approved for booster vaccination. J&J is different, however.

It “gets a little trickier” because a second dose of J & J’s vaccine appears to work “extremely well,” Baylor said. “Maybe it should have been a two-dose [vaccine] at the beginning.”

Subsequent week units the tone for all of earnings season

CNBCs Jim Cramer on Friday looked to the start of the reporting season and focused on the quarterly reports from major banks and other companies in the food and travel industries.

The “Bad money” The host’s outlook came after Wall Street stocks rallied sharply to rebound from Thursday’s big sell-off, which helped big averages end the week higher.

“What happens next week will shape the entire winning season,” said Cramer. “If we can get some good ones, we’ll be in party mode, but a negative series of numbers from the banks and some worrying Covid stats could make for a tough season of earnings.”

Sales and earnings per share forecasts are based on FactSet estimates:

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Tuesday: PepsiCo, JPMorgan Chase, Goldman Sachs win


  • Publication of results for the fourth quarter of 2021: 6 a.m. Conference call: 8:15 a.m.
  • Projected earnings per share: $ 1.53
  • Expected sales: $ 17.97 billion

JPMorgan Chase

  • Earnings release for the 2nd quarter 2021: 7:00 a.m. Conference call: 8:30 a.m.
  • Projected earnings per share: $ 3.16
  • Expected sales: $ 29.96 billion

“PepsiCo [will give] big numbers for us, but they also need to talk about how raw costs continue to rise, especially freight. JP Morgan should give us great numbers too, but they need to talk about trading and lending aren’t as strong as they should be, “Cramer said.

“I think both stocks are too high right now, given these two negatives,” he continued. “I would refrain from buying them before the receipts unless we get a significant withdrawal on Monday.”

Goldman Sachs

  • Publication of the results for the 2nd quarter of 2021: 7:30 a.m. Conference call: 9:30 a.m.
  • Projected earnings per share: $ 10
  • Expected sales: $ 12.13 billion

“If people are concerned about trading profits … they have to worry about Goldman because much of their business is trading profits, even if corporate financial income is very high,” he said.

Wednesday: Wells Fargo, Bank of America, Citigroup win

Wells Fargo

  • Earnings release for the 2nd quarter 2021: 8:00 a.m. Conference call: 11:30 a.m.
  • Forecast earnings per share: 95 cents
  • Projected sales: $ 17.77 billion

“Wells is more of a turnaround than banking history,” said Cramer. “If CEO Charlie Scharf tells us a good story about how the turnaround is going, then I think his stock can actually break away from the group, maybe even hit new highs for the year.”

Bank of America

  • Publication of results for the second quarter of 2021: 6:45 a.m. Conference call: 9 a.m.
  • Projected earnings per share: 77 cents
  • Expected sales: $ 21.86 billion

“If you think the economy will get stronger and interest rates will go up, and maybe even go up quickly, then you want to buy Bank of America stock right here now,” he said.

City group

  • Earnings release for the 2nd quarter 2021: 8:00 a.m. Conference call: 10 a.m.
  • Projected earnings per share: $ 1.99
  • Expected sales: $ 17.32 billion

“I’m not sure about the earnings quality of Citigroup, new CEO there, it’s a cheap stock, but I don’t want to stand behind it,” said the Mad Money presenter.

Delta Airlines

  • Earnings publication for the 2nd quarter 2021: ahead of market; Conference call: 10 a.m.
  • Projected earnings per share: $ 1.36
  • Expected sales: $ 6.14 billion

“I want to know how much damage the Delta-Covid strain is doing to Delta,” Cramer said. “We also need to know whether business travelers are finally coming back.”


  • Earnings publication for the 2nd quarter 2021: ahead of market; Conference call: 8:30 a.m.
  • Projected earnings per share: $ 9.31
  • Expected sales: $ 4.6 billion

“I sincerely hope they tell us their position on outfits like Engine # 1,” he said.

Thursday: UnitedHealth Group, Alcoa results

UnitedHealth Group

  • Earnings publication for the 2nd quarter 2021: ahead of market; Conference call: 8:45 a.m.
  • Projected earnings per share: $ 4.43
  • Expected sales: $ 69.47 billion

“It’s still for sale here,” said Cramer.


  • Earnings release for Q2 2021: After Market; Conference call: 5 p.m.
  • Projected earnings per share: $ 1.28
  • Expected sales: $ 2.64 billion

“They gave us a fantastic quarter last time, but now it looks like a lot of the cyclical stocks have peaked,” he said. “This is particularly important because aluminum goes into everything and the rising costs have been a major stumbling block for gross margins for many aluminum buyers.”

Friday: First Horizon, Kansas City Southern

First horizon

  • Publication of results for the second quarter of 2021: 6:45 a.m. Conference call: 9:30 a.m.
  • Projected earnings per share: 39 cents
  • Expected revenue: $ 771 million

“I think it could be a whopper because its core market in Tennessee is brand new,” said Cramer.

Kansas City South

  • Earnings publication for the 2nd quarter 2021: ahead of market; Conference call: 8:45 a.m.
  • Projected earnings per share: $ 2.17
  • Expected sales: $ 750 million

“Expect them to comment on Biden’s newfound hostility towards the industry,” he said. “I think the White House is trying to block this deal. I wouldn’t be surprised if they somehow get their way.”

Disclosure: Cramer’s charitable trust owns Wells Fargo stocks.

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