The Centers for Disease Control and Prevention and the Food & Drug Administration announced Tuesday that they have suspended the use of Johnson & Johnson’s COVID-19 vaccine out of an abundance of caution due to a rare blood clotting side effect.
The CDC and the FDA said they will stop using the drug, developed by J&J's Janssen Pharmaceuticals division, at federal vaccination sites after six people were found to have developed a rare blood clot issue within two weeks of receiving the single-dose shot. CDC data indicates 6.8 million doses of the vaccine have been administered as of April 12.
Johnson & Johnson's (JNJ) - Get Report vaccine -- which was approved by the FDA last month -- had formed a key part of the government's vaccine rollout, as it's a single-shot regime that requires standard refrigeration temperatures, compared to the ultra-cold conditions required for Pfizer and Moderna's two-shot doses.
CDC from Monday showed that nearly 190 million Americans have received at least one dose of either the Pfizer, Moderna, or Johnson & Johnson vaccines, with around 64 million people -- the majority of them over 65 -- now considered fully vaccinated.
Regeneron (REGN) - Get Report reports progress in a Phase 3 trial of its Regen-COV antibody cocktail, which it is testing to prevent COVID-19. The Tarrytown, N.Y., pharmaceutical company's Phase 3 trial gave the drug to "recently infected" asymptomatic people.
"Regen-COV reduced the overall risk of progressing to symptomatic COVID-19 by 31% (primary endpoint), and by 76% after the third day," Regeneron said in a statement. "The trial also demonstrated that Regen-COV shortened symptom duration and markedly reduced viral levels."
Regeneron said it will ask the U.S. Food and Drug Administration to expand the drug's authorization among people exposed to the virus who haven't yet been vaccinated.
This “could provide temporary stopgap protection as people await vaccines,” The company added.
This comes at a time when the number of new COVID-19 infections in the U.S. is continuing to surge in many states, amid vaccinations, after a lull earlier this year.
This past week, the U.S. logged more than 62,000 new infections, bringing the nation's total known infections closer to 31 million, according to data from Johns Hopkins. Scientists are also closely tracking new variants of the virus as they emerge, but no actual new "strain" -- using the narrow definition of the term that requires a variant to have significant biological differences -- has emerged so far.
States such as Michigan, Minnesota, and Nebraska have been seeing particularly worrying upward trends in new infections. The disease has been creeping up steadily in places like Massachusetts, New Jersey, New York, Delaware, and Florida, too.
Globally, nearly 131 million cases have been documented, with nearly 3 million deaths since the outbreak began over a year ago. And, the U.S. has seen nearly 555,000 deaths so far.
Chembio Diagnostics (CEMI) - Get Report shares spiked this past week as the company launched a test that can differentiate between COVID-19 and influenza. Chembio said the rapid immunoassay test produces results in 15 minutes and requires no instrumentation.
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Here is a list of the vaccine stocks to watch and their performance from the past week by percentage change at the close of trading on Monday, Apr. 12:
Pfizer | +1.90% 5 Day
Pfizer (PFE) - Get Report shares rose this past week as the New York healthcare titan and its COVID vaccine partner BioNTech (BNTX) - Get Report said they’re asking the Food and Drug Administration for emergency use authorization of the vaccine for kids aged 12 to 15. The vaccine already has EUA for everyone 16 and older.
Pfizer and BioNTech recently reported that testing indicated the vaccine was effective against the potent South African variant of the illness.
Top-line results from a Phase 3 analysis of 927 symptomatic cases of COVID-19 showed the companies’ vaccine, BNT162b2, was 91.3% effective, measured seven days through up to six months after the second dose, they said.
Also this past week, the companies said they would work to boost the manufacturing capacity of the vaccine to 2.5 billion doses by the end of the year.
Two weeks ago, Pfizer said it had begun human safety testing of a new pill that could be used to treat COVID-19 when symptoms first occur.
TheStreet Quant Ratings rates Pfizer as a Hold with a rating score of C+.
Moderna | +7.31% 5 Day
Shares of Moderna (MRNA) - Get Report were climbing after the New England Journal of Medicine reported that a follow-up study including a sample size of 33 people who received the drugmaker's COVID-19 vaccine in early trials show the antibodies it induced are still present six months after the second dose.
This matched similar results announced recently for the vaccine developed by BioNTech and Pfizer.
Interim results from a trial of 33 healthy patients treated with Moderna's mRNA-1273 vaccine indicated 94% efficacy in preventing COVID-19.
Antibody activity remained high in all age groups -- participants ranged between 18-55, 56-70, and 71+ -- for 209 days. Nearly all participants had evidence of COVID neutralization.
Moderna announced this past week that David Meline, Chief Financial Officer, and Lavina Talukdar, Senior Vice President & Head of Investor Relations, will participate in a fireside chat at the 20th Annual Needham Virtual Healthcare Conference on Apr. 15.
TheStreet Quant Ratings rates Moderna as a Hold with a rating score of C.
Johnson & Johnson | -1.10% 5 Day
The company's shares moved lower Tuesday after the Centers for Disease Control and Prevention and the Food & Drug Administration suspended the use of the drugmaker's coronavirus vaccine amid these concerns.
Shares of Johnson & Johnson declined 2.29% on Tuesday.
Six serious cases of unusual clots accompanied by low blood platelets, including a fatal one, have emerged after vaccination with the J&J shot, the European Medicines Agency said this past week.
One case previously happened during a clinical trial, which, at the time, J&J said it had found no evidence the vaccine was at fault.
The agency said it was investigating these cases and will decide whether regulatory action may be necessary, which usually consists of an update to the product information.
Earlier this month, Johnson & Johnson intercepted a batch of drug substances that would have formed part of its coronavirus vaccine production. Reports suggested as many as 15 million doses may have been affected.
TheStreet Quant Ratings rates Johnson & Johnson as a Buy with a rating score of B+.
AstraZeneca | -0.22% 5 Day
AstraZeneca (AZN) - Get Report shares fell this past week after the European Medicines Agency said the drug titan’s COVID vaccine is probably causing deadly blood clots in a small number of vaccinated people.
The agency said people should still get vaccinated for the coronavirus, but doctors must pay attention to the problem.
The U.K. government recommended against giving the AstraZeneca vaccine to adults under 30 because of the blood-clot issue.
Furthermore, Oxford University paused a study of the vaccine in children until the British regulator completes a review of blood-clotting cases, TheStreet.com reported.
TheStreet Quant Ratings rates AstraZeneca as a Buy with a rating score of B.
Novavax | -0.93% 5 Day
Novavax suffered a setback late last month after a report said the drugmaker was delaying signing a contract to supply its COVID-19 vaccine to the EU due to production issues.
TheStreet Quant Ratings rates Novavax as a Sell with a rating score of D.
Inovio Pharmaceuticals | -9.70% 5 Day
Although, the company earlier this month shared positive vaccine results and topped estimates when it recently reported its fourth-quarter earnings.
Inovio Pharmaceuticals said its coronavirus vaccine candidate is making progress. “We look forward to successfully completing our Phase 2 segment in the second quarter and seeking to advance to the Phase 3 portion of the trial," said Dr. Joseph Kim, CEO of Inovio, in a statement.
TheStreet Quant Ratings rates Inovio as a Sell with a rating score of D-.
BioNTech | +5.33% 5 Day
BioNTech (BNTX) - Get Report shares rose this past week as the company and its partner Pfizer said they’re asking the Food and Drug Administration for emergency use authorization of the vaccine for kids aged 12 to 15.
BioNTech traded at $123.04, up 7.5%. The vaccine is more important for the smaller company vs. its titan partner.
TheStreet Quant Ratings rates BioNTech as a Hold with a rating score of C.
Sanofi | +0.14% 5 Day
Sanofi (SNY) - Get Report and Translate Bio have begun trials for their vaccine candidate earlier this month. This comes after announcing a restart to its trials with GlaxoSmithKline (GSK) - Get Report in late February.
Sanofi will pay Translate Bio $25 million on the achievement of the milestone, they said. The drug is being developed under a collaboration and license agreement between the two companies.
TheStreet Quant Ratings rates Sanofi as a Buy with a rating score of B.
CureVac | -0.46% 5 Day
CureVac and its larger rival will use messenger RNA techniques, similar to those used by Pfizer and Moderna, to develop a multi-variant vaccine candidate that the pair hope will be available in 2022.
GlaxoSmithKline, which took a 10% stake in CureVac last year, also said it would support the manufacturing of CureVac's first messenger-RNA vaccine, known as CVnCoV, which the drugmaker said in November triggered antibody development in 250 human volunteers between the ages of 18 and 60 on a level similar to that of patients recovering from COVID-19.
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