Log in
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Dynamic quotes 

MarketScreener Homepage  >  Equities  >  London Stock Exchange  >  AstraZeneca PLC    AZN   GB0009895292


SummaryMost relevantAll NewsPress ReleasesOfficial PublicationsSector newsMarketScreener StrategiesAnalyst Recommendations

Pfizer, J&J urge clarity from FDA on future of COVID-19 vaccine trials once a vaccine is available

10/22/2020 | 12:44pm EST

Oct 22 (Reuters) - Pfizer Inc and Johnson & Johnson are seeking input from a U.S. Food and Drug Administration advisory committee on retaining and attracting volunteers for COVID-19 vaccine trials after a vaccine becomes available, if they know they might receive a placebo.

Both U.S. companies are among a handful with pivotal, late-stage COVID-19 vaccine trials underway.

The comments in letters ahead of the meeting of expert advisers on Thursday underscore dilemmas facing leading coronavirus vaccine developers and those whose large trials are just beginning or being planned.

Drugmakers are racing to find vaccines to protect against the coronavirus that has caused more than 1 million deaths globally. Many have begun trials involving tens of thousands of people who receive either an experimental vaccine or a placebo without knowing which.

J&J, in its comments, said a discussion is needed on the potential challenges of maintaining trial enrollment in ongoing large studies, especially after initial vaccines become available.

It is likely several vaccines will be needed to inoculate billions of people around the world.

The company said that once the first vaccines are licensed or authorized, it may lead volunteers to seek available vaccines instead of participating in ongoing trials. Volunteers already enrolled in trials might withdraw, it warned.

Pfizer, which is developing its vaccine with Germany's BioNTech SE, could provide early data from their late-stage vaccine trial later this month. Moderna Inc is likely to have early data on its candidate in November.

The FDA will then consider whether to issue a quick emergency use authorization (EUA), given the desperate need for a vaccine, or seek additional data before making a decision.

J&J is a step behind after its U.S. trial was paused earlier this month due to an illness in a study participant. AstraZeneca's U.S. vaccine trial is also paused due to an illness in its UK trial, but is expected to resume as soon as this week, Reuters reported, citing four sources.

In its guidance on EUAs for vaccines, the FDA said earlier in October that a drugmaker should continue to collect data in any ongoing trials for as long as feasible, even after getting an authorization, and work toward submission of a formal approval application as soon as possible.

Pfizer said it may have an ethical duty to inform at least some study volunteers that they have been given a placebo. It has proposed allowing them to move over to the vaccine arm of the study should its vaccine receive an EUA. (https://bit.ly/3dQqSxP)

J&J said it was evaluating a number of measures aimed at retaining trial volunteers.

"It would be helpful if FDA could share insights at the upcoming (meeting) on potential options they believe can be acceptable," J&J said. (https://bit.ly/37vCKEl)

(Reporting by Ankur Banerjee in Bengaluru, Julie Steenhuysen in Chicago and Michael Erman in New York; editing by Caroline Humer and Bill Berkrot)

© Reuters 2020
Stocks mentioned in the article
ChangeLast1st jan.
ASTRAZENECA PLC -0.06% 7800 Delayed Quote.2.54%
MODERNA, INC. -7.68% 141.01 Delayed Quote.620.91%
PFIZER, INC. 2.87% 39.41 Delayed Quote.3.21%
All news about ASTRAZENECA PLC
05:27pGlobal equity markets jump, bonds dip, on hopes of vaccine-led recovery
05:20pBrazil sees one-dose, unfrozen vaccine as ideal for COVID-19 -official
04:23pGlobal equity markets jump, bonds dip, on hopes of vaccine-led recovery
08:58aIONIS PHARMACEUTICALS : announces AstraZeneca's initiation of the Phase 2b clini..
06:12aASTRAZENECA : Crestor to be divested to Grünenthal in Europe
04:03aASTRAZENECA : sells former blockbuster cholesterol drug for $320 million
03:55aASTRAZENECA : Phakamisa Programme marks 10 years since launch with programme exp..
02:30aASTRAZENECA : to Sell Crestor Rights in Europe for Up to $350 Million
02:05aASTRAZENECA : Phakamisa Programme marks 10 years since launch with programme exp..
12:10aWorld shares rise on recovery hopes, following stellar November
More news
Financials (USD)
Sales 2020 26 494 M - -
Net income 2020 2 998 M - -
Net Debt 2020 13 181 M - -
P/E ratio 2020 44,0x
Yield 2020 2,69%
Capitalization 137 B 137 B -
EV / Sales 2020 5,68x
EV / Sales 2021 4,95x
Nbr of Employees 70 600
Free-Float 95,7%
Duration : Period :
AstraZeneca PLC Technical Analysis Chart | AZN | GB0009895292 | MarketScreener
Technical analysis trends ASTRAZENECA PLC
Short TermMid-TermLong Term
Income Statement Evolution
Mean consensus OUTPERFORM
Number of Analysts 26
Average target price 121,91 $
Last Close Price 104,68 $
Spread / Highest target 48,5%
Spread / Average Target 16,5%
Spread / Lowest Target -36,9%
EPS Revisions
Pascal Soriot Chief Executive Officer & Executive Director
Leif Valdemar Johansson Non-Executive Chairman
Pam P. Cheng Executive VP-Operations & Information Technology
Marc Pierre Jean Dunoyer Chief Financial Officer & Executive Director
Menelas N. Pangalos EVP-Biopharmaceuticals Research & Development
Sector and Competitors
1st jan.Capitalization (M$)
JOHNSON & JOHNSON-0.82%380 876
ROCHE HOLDING AG-4.76%282 467
PFIZER, INC.3.21%212 942
NOVARTIS AG-10.48%206 479
MERCK & CO., INC.-11.61%203 389