5:04 a.m. July 1, 2021
- By Jaimy Lee
Novavax's experimental COVID-19 shot has 86.4% efficacy against the Alpha variantShares of Novavax Inc. were up 2.5% in premarket trading on Thursday, the day after The New England Journal of Medicine published a looking at how Novavax's COVID-19 vaccine candidate performed in a Phase 3 clinical trial conducted in 15,000 participants in the U.K. An earlier analysis of the data was previously published as a preprint. According to the new study, Novavax's experimental vaccine has an overall efficacy rate of 96.4% against the original strain of the virus and an 86.3% efficacy rate against the Alpha variant, which was first identified in the U.K. and has been the most dominant form of the virus in many countries since the start of the year. Novavax did not mention the Delta variant, which is now the most dominant form of the virus in the U.K., in this study. The company is conducting separate studies of its experimental shot in the U.S. Novavax's stock is up 90.4% for the year, while the broader S&P 500 has gained 14.4%.
3:55 a.m. June 16, 2021
- By Jaimy Lee
Regeneron says its COVID-19 antibody treatment cuts the risk of death among hospitalized patientsShares of Regeneron Pharmaceuticals Inc. gained 0.1% in premarket trading on Wednesday after the company said its COVID-19 antibody therapy cut the risk of death in patients who have been hospitalized by 20%. This is the first time clinical research has demonstrated that Regeneron's antibody treatment has improved survival for hospitalized patients. The study, which is being conducted in the U.K. in patients who have not yet developed antibodies, follows other research that showed the company's antibody treatment can improve recovery times among people with mild or moderate forms of the disease. Regeneron said it is planning to ask the Food and Drug Administration to expand the emergency-use authorization in the U.S. to include these types of patients. Regeneron's stock is up 9.2% so far this year, while the broader S&P 500 has gained 13.0%.
5:36 a.m. June 15, 2021
- By Jaimy Lee
Novavax says efficacy of COVID-19 vaccine isn't affected when co-administered with the flu shotShares of Novavax Inc. were down 0.9% in trading on Tuesday, the day after the company said a study evaluating co-vaccination against COVID-19 and the flu demonstrated similar efficacy to administering Novavax's experimental COVID-19 shot alone. "Separate health care visits to cover both COVID-19 and influenza vaccinations will be burdensome," a Novavax executive said in a news release. As part of the Phase 3 clinical trial for its coronavirus vaccine in the U.K., the company also enrolled 431 participants in a sub-study that gave participants both the COVID-19 vaccine and the flu shot. In the , published Sunday, the researchers found that the immunogenicity of the flu shot was the same, while there was a "modest decrease" in the immunogenicity of the COVID-19 shot. Novavax also announced this week that its coronavirus vaccine when it comes to preventing symptomatic infection in roughly 30,000 participants enrolled in the Phase 3 clinical trial in the U.S. Novavax's stock has soared 86.2% so far this year, while the S&P 500 is up 13.3%.
10:49 a.m. April 27, 2021
- By Jaimy Lee
Novavax's stock jumps after Biden mentions its COVID-19 vaccine candidateShares of Novavax Inc. gained 12.1% in trading on Tuesday after President Joe Biden mentioned that the company's experimental COVID-19 vaccine may be nearing emergency-use authorization in the U.S. "The problem is right now we have to make sure we have other vaccines like Novavax and others coming on," he said during a speech. "And I think we'll be in a position to be able to share vaccines with other countries who are in real need. That's the hope and expectation." Novavax's still-investigational COVID-19 vaccine is currently being tested in a Phase 3 clinical trial in Mexico and the U.S. that began in December. (A separate late-stage study in the U.K. is also underway, and early data from that trial found that the vaccine candidate had an overall efficacy rate of 89.7%.) Novavax's stock has soared 126.0% so far this year, while the S&P 500 is up 11.5%.
4:44 a.m. April 16, 2021
- By Jenny Strasburg
J&J privately asked rival COVID-19 vaccine makers to probe clotting risks AstraZeneca was interested in joining forces to investigate the safety issue and communicate vaccine benefits and risks, but Pfizer and Moderna didn’t see the need for group actionJohnson & Johnson privately reached out to Covid-19 vaccine rivals to ask them to join an effort to study the risks of blood clots and speak with one voice about safety, but Pfizer Inc. and Moderna Inc. declined.
6:47 a.m. Feb. 22, 2021
- By Jaimy Lee
Novavax completes enrollment in Phase 3 clinical trial for its COVID-19 vaccine candidateShares of Novavax Inc. were down 6.2% in trading on Monday after the company said it had completed enrollment of the Phase 3 clinical trial for its COVID-19 vaccine candidate in Mexico and the U.S. Novavax said that 20% of the roughly 30,000 trial participants are LatinX, 13% are African Americans, 6% are Native Americans, and 5% are Asian Americans. Separately, 13% of all trial participants are 65 years old or older. Novavax's experimental vaccine requires two doses, spaced 21 days apart. The company last month from a late-stage trial of the same vaccine that is being conducted in the United Kingdom. Novavax's stock has soared 3,289.1% over the past 12 months, while the broader S&P 500 is up 15.3%.
3:51 a.m. Jan. 27, 2021
- By Jaimy Lee
Regeneron says its COVID-19 antibody cocktail still works against new strains in lab testShares of Regeneron Pharmaceuticals Inc. gained 1.2% in premarket trading on Wednesday after the company said its COVID-19 antibody cocktail still works against two new more infectious strains of the virus: the B.1.1.7 and the B.1.351. The company worked with researchers at Columbia University to assess how the drug, which has received emergency authorization in the U.S., works against the new strains in a laboratory, according to a preprint published Wednesday. (A preprint is a type of preliminary study.) The study was not conducted in humans. Regeneron said its antibody cocktail, made up of imdevimab and casirivimab, remained effective against the B.1.1.7 strain, but casirivimab's potency was reduced against the B.1.351 strain, which was first identified in South Africa. It has not yet tested the cocktail against the P.1 strain that has emerged from Brazil. Close to 300 people in the U.S. have confirmed cases with the B.1.1.7 strain, which was first detected in the United Kingdom, and the first case of P.1. in the U.S. was identified this week in Minnesota. The B.1.351 has not yet been detected in the U.S. BioNTech SE /Pfizer Inc. and Moderna Inc. also ran similar studies evaluating if their vaccines can protect against the new variants. Regeneron's stock has rallied 60.3% over the past year, while the S&P 500 is up 16.8%.
4:55 a.m. Jan. 25, 2021
- By Jaimy Lee
Moderna: Lab study confirms its COVID-19 vaccine still protects against new variantsShares of Moderna Inc. gained 4.6% in premarket trading on Monday afer the company said laboratory studies demonstrated that its COVID-19 vaccine can still protect people against two new coronavirus variants: the B.1.1.7 that was first identified in the United Kingdom, and the B.1.351 strain, out of South Africa. The study was not conducted in humans. The findings were released in a news release, and the company said it expects the results to be published in preprint form. Moderna said the in-vitro studies showed that the B.1.1.7 variant had no "significant" impact on neutralizing antibody titers developed as a result of vaccination; however, they also demonstrated that the vaccine was less effective against the B.1.351 variant. In this case, the vaccine still produced levels of neutralizing antibody titers that were protective, but the titer levels were lower. Moderna said it now plans to study booster doses for its two-dose COVID-19 vaccine, to see if a third dose of some kind can increase neutralizing antibody titers and if a booster can specifically protect against the B.1.351 variant. This booster, mRNA-1273.351, will be tested in preclinical studies and a Phase 1 study in the U.S. The U.K. and South Africa variants have because they are more infectious and carry a higher viral load than other strains of the virus. Moderna's stock has gained 520.3% over the past 12 months, while the S&P 500 is up 15.6%.
4:24 a.m. Jan. 25, 2021
- By Jaimy Lee
CDC says doses of COVID-19 vaccines can be spaced out by up to 42 daysThe Centers for Disease Control and Prevention updated for vaccine administration to say that it's okay to space out the first and second doses of the currently available COVID-19 vaccines by up to 42 days, if necessary. The regulatory labels say that doses of the BioNTech SE and Pfizer Inc. vaccine should be spaced 21 days apart, while the second dose of Moderna Inc.'s 's vaccine is expected to be administered 28 days after the first dose. "However, if it is not feasible to adhere to the recommended interval, the second dose of Pfizer-BioNTech and Moderna COVID-19 vaccines may be scheduled for administration up to 6 weeks (42 days) after the first dose," the CDC said. The United Kingdom has also said of its authorized vaccines, which include the AstraZeneca and University of Oxford vaccine in addition to the ones developed by BioNTech/Pfizer and Moderna, as needed. Over the past 12 months, BioNTech's stock has rallied 209.9%, Pfizer shares are down 3.1%, and Moderna's stock has soared 520.3%. The S&P 500 has gained 15.6% over the past year.
11:14 a.m. Jan. 15, 2021
- By Jaimy Lee
CDC: New more infectious strain of the coronavirus likely to become dominant in the U.S. by MarchThe Centers for Disease Control and Prevention said Friday that a new more infectious strain of SARS-CoV-2 will likely become the most dominant form of the virus in the U.S. by March. The strain, B.1.1.7, was first identified by health officials in the United Kingdom in December. The CDC said in a new that enhanced genomic sequencing, in addition to vaccination and standard mitigation practices like mask-wearing and social distancing, will be needed to stem the spread of the new strain. President-elect Joe Biden announced Thursday that for a national genomic sequencing surveillance system, given that the U.S. is trailing other developing countries using this technology in their pandemic responses. "CDC's modeling data show that universal use of and increased compliance with mitigation measures and vaccination are crucial to reduce the number of new cases and deaths substantially in the coming months," the agency said. It also said the U.S. should conduct "strategic testing" of people without symptoms but who are at high-risk for contracting the virus. More than 70 people in 12 states are confirmed to have been infected with the new strain, as of Jan. 13, .
5:36 a.m. Nov. 17, 2020
- By Jaimy Lee
Moderna signs supply deal with U.K. for COVID-19 vaccineShares of Moderna Inc. were down 1.8% in premarket trading on Tuesday after it announced a new supply deal with the United Kingdom government for its experimental COVID-19 vaccine. Per the terms, Moderna will begin supplying the government with its vaccine candidate in March if it's approved by U.K. health regulators. The company on Monday announced that , making it the second drugmaker to announce that a COVID-19 vaccine candidate was at least 90% efficacious in preventing symptomatic infections with the coronavirus. Moderna's stock has soared 400.7% so far this year. The S&P 500 has gained 12.2% year-to-date.
5:52 a.m. Oct. 27, 2020
- By Jaimy Lee
Novavax's stock rises 3% as it announces plans to share Phase 2 vaccine data this weekShares of Novavax Inc. gained 2.9% in trading on Tuesday after the company said it expects to launch a Phase 3 trial for its COVID-19 vaccine candidate in Mexico and the U.S. by the end of next month. It already started a late-stage trial for its vaccine in the U.K. in September. Novavax has for its experimental COVID-19 vaccine from its Phase 1 clinical trial, in September in the New England Journal of Medicine. It said Tuesday it plans to present new reactogenicity data from the Phase 2 trial on Friday, during an advisory committee on immunization practices meeting convened by the Centers for Disease Control and Prevention. Novavax's stock has soared 2,180.1% so far this year, compared with the S&P 500 , which is up 5.2%.
11:21 a.m. Oct. 12, 2020
- By Tomi Kilgore
Coronavirus update: Global daily case tally sets another record with a rise of nearly 380,000 on Saturday, as Trump claims he is now immune and can’t transmit the virus U.S. cases jump by more than 50,000 in a day as 38 states are seeing weekly increases; Twitter marks Trump’s tweet about immunity as ‘misleading,’ while Regeneron’s CEO won’t back Trump’s calling antibody treatment a ‘cure’A continued surge in new cases of the coronavirus that causes COVID-19, including another record one-day rise globally and with more than three-fourths of the U.S. states seeing an increase in cases, has prompted calls for new shutdown measures, at a time that President Trump claimed that he is now immune and can’t transmit it to others.
4:16 a.m. Sept. 16, 2020
- By Jaimy Lee
Analyst: Vaccines can sometimes trigger rare disorder reportedly identified in AstraZeneca trialThe participant in AstraZeneca's Phase 3 study of its experimental COVID-19 vaccine who triggered the clinical trial's hold reportedly was diagnosed with transverse myelitis, which is a spinal disorder potentially associated with vaccines, according to RBC Capital Markets' Brian Abrahams. AstraZeneca's stock was up 0.9% in premarket trading on Thursday. the diagnosis of transverse myelitis, which has not been confirmed by AstraZeneca; however, the company has confirmed it halted the trial due to a "potentially unexplained illness." Abrahams wrote in a note on Tuesday to investors that instances of vaccine-related transverse myelitis are rare, though there are 119 cases recognized by the Food and Drug Administration between 1985 and 2017. "It makes sense that the [adverse event] will be fully investigated prior to continuation of vaccine administration," he wrote. "It also highlights the importance of following volunteers for weeks to months post-dosing, as if this side effect were actually related to this or other COVID-19 vaccinations." Shares of AstraZeneca, which is developing the vaccine with the University of Oxford, are up 7.6% so far this year. The S&P 500 has gained 5.2%.
7:18 a.m. Sept. 9, 2020
- By Steve Goldstein
AstraZeneca may resume halted COVID-19 vaccine trial next week: reportAstraZeneca may resume its halted trial of its COVID-19 vaccine as early as next week, , citing people familiar with the matter. The company halted the trial after the discovery of a sick participant, who contracted transverse myelitis, the report said. The trial may see further pauses, the report said, citing a person close to the process.
9:53 a.m. Aug. 24, 2020
- By Ciara Linnane
Coronavirus update: WHO says plasma treatment touted as breakthrough by Trump is unproven, advises caution AstraZeneca stock climbs on reports Trump may fast track its COVID-19 vaccine candidate; company says speculation is ‘premature’The World Health Organization said Monday the plasma therapy that received an emergency use authorization from President Donald Trump as a “breakthrough” in treating COVID-19 is still unproven and cautioned that the there is “very low evidence” that it is safe and effective.