Source: Conversation
As AstraZeneca is no longer the preferred vaccine for Australian adults under 50, attention is turning to what other COVID-19 vaccine options are in our arsenal.
The federal government has ordered 40 million doses of the Pfizer vaccine, which will become the mainstay of the rollout, while AstraZeneca will continue to be administered for people over 50 in the current phase 1B.
The federal government also this week ruled out using Johnson & Johnson’s one-shot vaccine.
But Australia does have a deal for a third vaccine, by US biotech company Novavax. The government has ordered 51 million doses of this vaccine, though it’s yet to be approved by Australia’s drug regulator, the Therapeutic Goods Administration (TGA), which is expected to make a decision in the third quarter of the year.
At this stage, Novavax would be made offshore and imported, although Melbourne-based biotech CSL can make the vaccine if requested by the federal government.
Categories: Vaccine
Novavax Inc. partner PolyPeptide Group AG plans an initial public offering on the Swiss Stock Exchange in the second quarter, giving public investors exposure to a company that supplies ingredients for a coronavirus vaccine candidate.
The contract manufacturer plans to float a 40% stake, with the placement to consist of both new and existing shares, it said in a statement Monday. The business could be valued at about 1.75 billion euros to 2.5 billion euros ($3 billion), though the amount could still change depending on investor demand, a person familiar with the matter said.
The company makes therapeutic peptides, or short strings of amino acids that are the building blocks of proteins, used by pharmaceutical and biotech companies including Covid-19 vaccine developer Novavax.
PolyPeptide is owned by Swedish billionaire Frederik Paulsen, who is also chairman of drugmaker Ferring Group, which is focused on reproductive medicine and women’s health.
PolyPeptide reported revenue of 223 million euros and adjusted earnings of 62 million euros for 2020. The company expects to use the IPO proceeds to fund capital expenditure and expansion into adjacent areas such as oligonucleotides, which are short DNA or RNA molecules, and neoantigen, or mutated cancer protein, therapies.
https://www.bloomberg.com/news/articles/2021-04-12/novavax-vaccine-ingredient-supplier-polypeptide-plans-swiss-ipo?sref=eGA8az79
By Carl O’Donnell
April 13 (Reuters) – Novavax Inc has pushed back the timeline for hitting its production target of 150 million COVID-19 vaccine doses per month until the third quarter due to supply shortages including bags used to grow cells, a company spokeswoman told Reuters.
Novavax executives had previously said full-scale vaccine production could be achieved by mid-year. The company told Reuters in January it expected to reach full production capacity by May or June.
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“We said during our earnings call that we expect all capacity being online by around mid-year. We’re continuing to refine that timing as we get closer, which now leads us to think we’re online/at full capacity by Q3,” Novavax communications director Amy Speak said by email on Monday.
“There are some supply shortages that come and go that have contributed to the revision in timing,” she added. “These have included things like the bioreactor bags and filters.”
Novavax could receive UK regulatory authorization for its vaccine as early as this month after releasing impressive UK trial data. It anticipates clearance in the United States could come as early as May after soon-to-be released data from its U.S. vaccine trial are reviewed by regulators.
The Maryland-based company is one of several COVID-19 vaccine makers that have had to push back production timelines due to industrywide shortages of raw materials and difficulties getting plants up and running.
https://finance.yahoo.com/news/novavax-says-supply-shortages-delaying-100000637.html
The Food and Drug Administration asked states on Tuesday to temporarily halt using Johnson & Johnson’s Covid-19 vaccine “out of an abundance of caution” after six women in the U.S. developed a rare blood-clotting disorder that left one woman dead and another in critical condition.
“Right now, these adverse events appear to be extremely rare,” the FDA said in a joint statement with the Centers for Disease Control and Prevention. “COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”
All six cases occurred in women ages 18 to 48, with symptoms developing six to 13 days after they received the shot. Doctors typically treat that type of blood clot with heparin, but health regulators noted that could be dangerous in this case and recommended a different treatment.
J&J said in a statement that “no clear causal relationship” has been identified between the blood clots and the vaccine, adding it is working closely with regulators to assess the data.
People who got the J&J vaccine more than a month ago are at very low risk for developing the blood clots, Dr. Anne Schuchat, the principal deputy director of the CDC, told reporters on a conference call Tuesday.
“For people who recently got the vaccine within the last couple weeks, they should be aware to look for any symptoms,” she said. “If you’ve received the vaccine and developed severe headaches, abdominal pain, leg pain or shortness of breathe you should contact your healthcare provider and seek medical treatment.”
The blood clotting generally occurs about a week after vaccination, but not more than three weeks after, with a median timeframe of 9 days, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said on the call.
https://www.cnbc.com/2021/04/13/us-regulators-reportedly-call-for-pause-in-use-of-johnson-johnson-vaccine-due-to-clotting-issues.html
(CNN) The US Centers for Disease Control and Prevention and the US Food and Drug Administration are recommending that the United States pause the use of Johnson & Johnson’s Covid-19 vaccine over six reported US cases of a “rare and severe” type of blood clot.
The six reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States.
Federal official: CDC, FDA taking reports of blood clots and J&J Covid-19 vaccine ‘seriously’
All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination, according to a joint statement on Tuesday from Dr. Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance,” the statement said. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”
https://www.cnn.com/2021/04/13/health/johnson-vaccine-pause-cdc-fda/index.html