Moderna’s Chief Medical Officer Paul Burton said on Sunday that his company was preparing to provide large amounts of its vaccine booster against omicron and other COVID-19 variants this fall.
“We’re confident by the fall of this year we should have large amounts of that new booster vaccine that will protect against Omicron and other variants,” Burton said in an interview on CBS’s “Face the Nation.”
Last month, Moderna announced that its new bivalent COVID-19 booster shot was more effective against all variants than the company’s currently available coronavirus vaccine.
The company has said it expects initial data on its omicron-specific vaccine to be available in the second quarter of this year
Burton also made a general push on Sunday for people who have not already done so to receive their COVID-19 booster.
“People are eligible now to get boosted. I would absolutely recommend it,” he said on Sunday.
Also on “Face the Nation,” former member of the Trump administration’s White House coronavirus task force, Deborah Birx, urged the U.S. to ramp up on its preparations for a potential COVID-19 surge in the summer, citing increasing case numbers in South Africa.
“Each of these surges are about four to six months apart,” she said of the South African outbreaks. “That tells me that natural immunity wanes enough in the general population after four to six months that a significant surge is going to occur again. And this is what we have to be prepared for in this country.”
As of Saturday, the U.S. reported 23,349 daily COVID-19 cases, far below more than a million daily cases seen during the omicron outbreak in January.
All dining in restaurants will also be halted between 1 and 4 May, with people being asked to cook at home.
The city has reported 295 new cases since 22 April.
Of these, 123 cases were found in the Chaoyang, Beijing's most populous district, which is now set for three rounds of mass testing.
The streets of Beijing were quiet at the start of the five-day Labour Day break. One female resident, a finance worker, started to cry as she told Reuters how she felt.
"You look at a city that used to be crowded and now is empty. And you can't help but wonder how these people manage to survive," she said.
Earlier this month residents rushed to stock up essential supplies and long queues were seen outside supermarkets and shops, despite government assurances there is sufficient food.
There are fears the city could face a similar situation to Shanghai, which has seen 25 million people shut in their homes for weeks and left some struggling to find food and other basics.
Since the outbreak began in early March, more than 500,000 people in Shanghai have tested positive for the virus.
But the city reached a milestone on Saturday, recording no new daily Covid cases outside of quarantine areas.
A Food and Drug Administration advisory committee has put Gaithersburg, Maryland-based Novavax’s COVID-19 vaccineon its June 7 agenda.
The Vaccines and Related Biological Products Advisory Panel includes independent physicians and scientists who make recommendations about vaccine authorization to the FDA, which most often follows those recommendations.
Novavax submitted its vaccine for FDA approval Dec. 31, 2021. Its COVID-19 vaccine is already approved or in use by several other countries in Asia and Europe.
If approved for use in the U.S., it would make Novavax a latecomer to the COVID vaccine arsenal, though its vaccine is different from the mRNA vaccines supplied by Pfizer and Moderna.
The Novavax vaccine is a more traditional protein-based vaccine that can also be stored at much higher refrigeration temperatures. Novavax has also said that because it is a traditional-type vaccine, some hesitant to get the mRNA vaccines might be more willing to take it.
“We continue to hear from physicians, healthcare organizations and consumers who are anxiously awaiting another vaccine option. We believe our vaccine, built on a well-understood protein-based vaccine platform, can play a part in fulfilling this need,” Novavax CEO Stanley Erck said in a statement Friday.
Novavax was among early participants in the federal government’s Operation Warp Speed, receiving $1.6 billion in 2020 to develop and manufacture a COVID vaccine.
In February, Novavax published research supporting its vaccine as effective in teens. It has also been testing a combination COVID and influenza vaccine.
Some Broadway theaters are ending the policy of requiring customers to show proof of vaccination.
In a statement, the Broadway League said that beginning Sunday, the owners and operators of all 41 Broadway theaters are extending the mask requirement at least through the end of May but many will no longer check for vaccination status.
The announcement recommended that theatergoers check individual theaters’ websites for more information. An update on masking policies beginning for June will be issued in May.
Several shows including “Macbeth,” “Plaza Suite” and “The Music Man” have canceled performances in recent months after cast members tested positive for COVID-19.
In early March, New York Mayor Eric Adams made masks optional in schools and said indoor venues such as restaurants, theaters and gyms were no longer required to check vaccination status. Broadway theaters said they would check vaccination status at least through April 30.
On April 19, the Japanese health ministry officially authorized the coronavirus vaccine developed byUSpharmaceutical company Novavax Inc. to be used for people aged 18 and older. It is the fourth vaccine made available in the country, following mRNA vaccines made by Pfizer and Moderna and AstraZeneca's viral vector vaccine. The ministry is expected to start administering the Novavax vaccine in late May at the earliest.
Protein-based
The Novavax shot is what is known as a "recombinant protein vaccine." The chemical process involves an artificially made spike protein stimulating an immune response in the recipient. Similar vaccines are widely used for people with shingles and type-B hepatitis, among other viruses.
The ministry hopes to administer the vaccine to people who are allergic to the existing vaccines. Protein-based vaccines are known to cause allergic reactions with less frequency.
Two-dose vaccine and booster
Like the mRNA options, the Novavax vaccine is a two-dose shot with an interval of about three weeks. The ministry plans to make a booster shot available at least six months after the second dose. It is asking prefectural governments to open at least one facility for the administration of the Novavax vaccine. The shot must be stored and transported at temperatures between 2 and 8 degrees Celsius. They can be stored in standard-use refrigerators. Unused doses remain effective for nine months.
Manufactured in Japan
Though it was developed by an American company, the Novavax vaccine will be produced in Japan at the Takeda Pharmaceutical Co. factory in Yamaguchi Prefecture. The company plans to produce about 150 million doses within a year.
The ministry says the government arranged the purchase of the vaccine last September to ensure there would be a stable supply in the event of possible export restrictions on overseas vaccines. The ministry says it chose the Novavax vaccine both because of the strong track record of protein-based shots and to offer people a variety of options.
According to Novavax, its vaccine has been approved for conditional sale in the EU and UK. It has not been approved in the US, though the company did apply for emergency use authorization with the Food and Drug Administration earlier this year.
Effectiveness
On December 15, 2021, the New England Journal of Medicine published a clinical study on the vaccine by Novavax, US universities, and various medical organizations. It targeted about 30,000 people aged 18 and older in the US and Mexico between December 2020 and February 2021. It found the vaccine's effectiveness at preventing symptoms three weeks after the second dose was 90.4 percent, while its effectiveness at preventing medium and severe illness was 100 percent. At the time of the study, the Alpha and Beta variants had spread widely. The vaccine prevented symptoms in 92.6 percent of cases of these strains.
Side effects less common than with other vaccines
The study found that side effects subside within one or two days in most cases. They were also reported less often than after other vaccines and there were no confirmed cases of heart muscle inflammation or thrombosis.
"Good to have alternative"
"The Novavax vaccine is manufactured with the same method as vaccines that were used before the pandemic," says Professor Nakayama Tetsuo, a virologist with Tokyo's Kitasato University. "This means people may feel it is safer than the others."
"It is good to have another alternative to the mRNA vaccines," he adds. "Some people are hesitant to receive mRNA vaccines, due to side effects. This has led to a delay in the rollout of the third shot. The Novavax vaccine is believed to lead to side effects with less frequency so I think it will help increase the percentage of people with third shots."
Around 40% of the 2,000 staff who work in vital health protection teams are set to lose their jobs.
It is also reported that the UKHSA is also proposing the suspension of all regular asymptomatic testing in hospitals and care homes from May to save money for a potential winter spike in cases.
Health experts have criticised the move as figures reveal Covid-19 hospitalisation numbers remain high. There are currently around 15,000 patients in hospital with Covid-19 – just 5,000 less than the first wave in April 2020.
A breeding ground for Covid-19.
The Royal College of Nursing has dubbed the news “deeply concerning” and warned the end of testing could lead to hospitals and care homes becoming a breeding ground for Covid-19.
Patricia Marquis, the RCN England director, said: “We had been working closely with the UKHSA and other unions to try to minimise job losses and are dismayed that the announcement to end those fixed-term contracts was not discussed with the trade unions at a recent national meeting.
“Ending routine testing in hospitals and care homes must not lead to them becoming a breeding ground for COVID-19.
“If this change happens, for it to be effective its impact must be closely monitored and all relevant data published more frequently so changes can be made quickly to protect staff and patients.
“COVID-19 remains a safety risk and employers must continue to do all they can to protect staff at work and comply with health and safety law.”
Pandemic tailwinds have been spirited away on the wind of change. Companies which thrived as Covid-19 concerns trumped any other global developments are now feeling the effect of its waning influence.
This has been evident from the performance of ecommerce stocks, streamers and all manner of WFH names. Of course, coronavirus stocks - that segment which came into being as the pandemic took hold – are feeling the effect too.
With the pandemic now on the backfoot in many parts of the world, the demand for Covid vaccines is dropping, a fact noted by B. Riley’s Mayank Mamtani.
“The imbalance to supply & demand for these products has become particularly alarming, as already evidenced by JNJ 1Q earnings' guidance and anticipated 1Q earnings' commentary from AZN, BNTX/PFE, MRNA, REGN,” Mamtani explained.
But more so than any of those companies, one of the pandemic era’s biggest stars has suffered the most from the shift in sentiment.
Novavax (NVAX) shares are down 81% over the past 12 months, as the Maryland-based vaccine maker still hasn’t managed to get its Covid-19 across the finish line in the U.S. The company has yet to receive emergency use authorization (EUA) for its protein-adjuvanted shot.
However, interestingly, while investors have evidently become impatient around the slow regulatory progress, as many developed nations ready for the transition to a post-pandemic world, Mamtani thinks Novavax remains “relatively the most protected from the generally bearish investor sentiment brewing for C-19 vaccine & therapeutics' peers.”
But that could be dependent on how the anticipated ~mid-May Q1 print turns out. To get investors back on side, Mamtani expects Novavax to “reassure investors on the near-term and long-term strength of its recently established global vaccine biz.”
By reiterating the FY22 revenue guidance of $4-5 billion, the company could take the first step in rebuilding investor confidence, with its adjuvanted protein-based platform “continuing to serve as a source of delivering diversified, multi-product portfolio for COVID, flu, malaria, and RSV.”
That said, given the demand uncertainty, Mamtani has slashed his price target from $250 to $203. No need to get too forlorn – there’s still upside of 350% from current levels. Mamtani’s rating stays a Buy. (To watch Mamtani’s track record, click here)
The Street’s average target also offers plenty of returns; at $169.4, the figure represents potential one-year upside of ~276%. Overall, the analyst consensus rates this stock a Moderate Buy, based on 5 Buys vs. 2 Holds.
