1) Oxford vaccine chief says the R21/Matrix M malaria vaccine is 'nearly at the finish line' and aims for EUA

DETAILS:

• Here are a few excerpts from an article that includes the Oxford vaccine chief providing an update on the malaria shot. A key component of the vaccine is the Novavax adjuvant Matrix-M. Oxford chose Matrix M after deciding it was the best adjuvant. In tests, Matrix M was found to greatly increase immune responses compared to other adjuvants used with the malaria vaccine. The headline of the article is: Oxford vaccine chief says effective malaria shot is 'nearly at the finish line'

The head of the University of Oxford's pioneering vaccine research centre has revealed that a highly effective shot to combat malaria is “nearly at the finish line”.

Prof Adrian Hill, director at the Jenner Institute, says his team's shot — named the R21/Matrix-M ― could protect against the disease and save thousands of lives every year.

The pioneering drug is currently undergoing high-level research trials in Africa, where malaria kills at a rate of almost one child a minute.

The mosquito-borne disease has seen a resurgence in recent years and is estimated to have killed 620,000 people around the world in 2020, according to the World Health Organisation.

Prof Hill made the comments during a field visit for Phase III trials of R21/Matrix-M in northern Tanzania. Some 4,800 children are involved in clinical trials across Africa and it is hoped an update on the research progress will be released soon.

Results of the Phase II trials released last year showed a high-level efficacy of 77 per cent — slightly above a WHO-specified efficacy goal of 75 per cent.

Scientists say if the drug receives approval, hundreds of millions of doses could be available to help stop the threat of malaria.

“This is what it has all been leading up to,” Mr Hill told the The Times. “People have been at this since 1908.” ....

Ireland-born Prof Hill last year suggested the vaccine should be given the same emergency approval as Covid-19 shots, instead of waiting years for full trials to be completed.

“Nobody’s really ever asked that question before Covid, but we’re going to do so, and have been doing so, and regulators are sounding interested,” he said. ....

Some 241 million cases of malaria disease were recorded worldwide in 2020, 14 million more than a year earlier, according to the WHO.

• Here are the relevant excerpts from an article about the R21/Matrix M vaccine:

The R21 vaccine candidate is produced by expressing recombinant HBsAg virus-like particles in Hansenula polymorpha, comprising the central repeat and the C-terminus of the circumsporozoite protein (CSP) fused to the N-terminal end of HBsAg10. R21 was created by the University of Oxford, located in England. ....

R21 was mixed immediately before administration with Matrix-M™, a saponin-based vaccine adjuvant produced by Novavax AB, Uppsala, Sweden. 

The Matrix-M component of the malaria vaccine will be manufactured and supplied to SII by Novavax. Under Novavax's agreement with Serum Institute, SII has rights to use Matrix-M in the vaccine in regions where the disease is endemic and pay Novavax royalties on its market sales. Additionally, Novavax will have commercial rights to sell and distribute the SII-manufactured vaccine in certain countries, primarily in the travelers' and military vaccine markets.

On April 23, 2021, Adrian Hill, Director of the Jenner Institute and Lakshmi Mittal and Family Professor of Vaccinology at the University of Oxford, and co-author of a non-peer-reviewed paper, said in a press release, ‘These new results support our high expectations for the potential of this vaccine, which we believe is the first to reach the WHO’s goal of a vaccine for malaria with at least 75% efficacy. With the commitment by our commercial partner, the Serum Institute of India, to manufacture at least 200 million doses annually in the coming years, the vaccine has the potential to have major public health impact if licensure is achieved.’ The Phase 2b clinical trial targeted children 5-17 months. ....

Here is the link:
https://www.precisionvaccinations.com/vaccines/r21-matrix-m-malaria-vaccine

• In addition, here's what an InvestorVillage user, Stakeholder2016, added on the benefits of this to Novavax:

3) Lawmakers ask the FDA about the slowness of reviewing Covid vaccines for young children

Here is a clip on the details of a Congressional request to the FDA for an explanation of the delay for the under-5 age group vaccine:

Yesterday, Congress’s Select Subcommittee on the Coronavirus Crisis sent a letter (PDF) to FDA Commissioner Robert Califf, M.D., requesting a briefing on the status of COVID-19 vaccines for the under 5 age group.

The letter comes after U.S. chief medical adviser Anthony Fauci, M.D., indicated on CNN that the FDA is considering holding off on reviewing Moderna’s vaccine candidate in order to authorize it at the same time as Pfizer’s to “not confuse people” with a staggered rollout, the lawmakers wrote. That could lead to a potential delay of several weeks for Moderna's shot, they said.

The reported timing of the reviews prompted the congressional committee to request a staff briefing by May 9 to gather more information. Rep. James Clyburn, the committee chairman who signed the letter, reminded Califf that up to 1.5% of all child COVID-19 cases result in hospitalization.

Here is the link to the article:
https://www.fiercepharma.com/pharma/congress-requests-fda-explanation-delay-under-5-covid-19-vaccine

4) Novavax currently has an average rating of "Buy" and a consensus price target of $198, which would be a gain of about 300% from the current price

DETAILS: 

• Here are excerpts about the consensus and individual ratings and price targets of Novavax by different firms:

Novavax, Inc. (NASDAQ:NVAX – Get Rating) has received a consensus rating of “Buy” from the nine research firms that are presently covering the company, MarketBeat.com reports. Four equities research analysts have rated the stock with a hold rating and four have given a buy rating to the company. The average 12 month price objective among analysts that have covered the stock in the last year is $204.86.

Several equities analysts have weighed in on the stock. Jefferies Financial Group assumed coverage on shares of Novavax in a report on Tuesday, February 22nd. They set a “buy” rating and a $198.00 price target on the stock. Cantor Fitzgerald lowered their price target on shares of Novavax from $282.00 to $174.00 and set an “overweight” rating on the stock in a report on Monday, February 14th. StockNews.com initiated coverage on shares of Novavax in a research report on Thursday, March 31st. They set a “hold” rating on the stock. Cowen initiated coverage on shares of Novavax in a research report on Friday, January 21st. They set an “outperform” rating and a $150.00 price objective on the stock. ....

A number of hedge funds have recently modified their holdings of NVAX. State Street Corp grew its holdings in Novavax by 8.7% during the fourth quarter. State Street Corp now owns 1,899,220 shares of the biopharmaceutical company’s stock worth $271,721,000 after acquiring an additional 152,593 shares during the period.

Here is the article:

5) 60% of Americans have at least partial antibodies that indicate a past Covid infection, according to the CDC

In a past newsletter, we reported that infection from Omicron does not provide much protection against re-infection. Omicron has a unique mutation that causes it to self-destruct a portion of the spike protein, making it harder for the immune system to produce useful neutralizing antibodies. Here is a clip describing what the CDC reports about past infections in the US:

At a briefing for reporters on Tuesday, the CDC's Dr. Kristie Clarke said so many people caught omicron over the winter that almost 60% of everyone in the U.S. now have antibodies to the virus in their blood.

That number is even higher for children — almost 75% of children 11 and younger have antibodies to the virus.

Clarke said the finding means many people have at least some immunity to the virus. But CDC officials stressed that people should still get vaccinated, because vaccination provides the strongest, broadest protection against getting seriously ill. Immunity provided by previous infection may or may not be as protective against severe disease.

The CDC also said that cases of COVID-19 continue to rise, going up 23% last week to 44,416 a day. Deaths continue a months-long decline to 314 a day, or 13% less than the week before. Hospitalizations are on the uptick at 1,629 a day, up 7% over the previous week, according to CDC Director Rochelle Walensky.

About 1.5% of the U.S. population lives in communities where there is a high prevalence of COVID at the present time, with 6.5% in medium prevalence areas and the rest (92%) in communities with low levels of COVID.

https://www.npr.org/2022/04/26/1094817774/covid-19-infections-us-most-americans

6) Study: Mix-and-match heterologous booster doses provide much higher protection than boosting with the same vaccine. 

Yet another study has found that mix-and-match heterologous boosting is much more effective than homologous boosting, which is boosting using the same vaccine as the primary series. Here are a few excerpts from a large-scale prospective cohort study from The Lancet:

Policy makers urgently need evidence of the effectiveness of additional vaccine doses and its clinical spectrum for individuals with complete primary immunisation schedules, particularly in countries where the primary schedule used inactivated SARS-CoV-2 vaccines. ....

We calculated an adjusted vaccine effectiveness (weighted stratified Cox model) in preventing symptomatic COVID-19 of 78·8% (95% CI 76·8–80·6) for a three-dose schedule with CoronaVac, 96·5% (96·2–96·7) for a BNT162b2 booster, and 93·2% (92·9–93·6) for an AZD1222 booster. The adjusted vaccine effectiveness against COVID-19-related hospitalisation, ICU admission, and death was 86·3% (83·7–88·5), 92·2% (88·7–94·6), and 86·7% (80·5–91·0) for a homologous CoronaVac booster, 96·1% (95·3–96·9), 96·2% (94·6–97·3), and 96·8% (93·9–98·3) for a BNT162b2 booster, and 97·7% (97·3–98·0), 98·9% (98·5–99·2), and 98·1% (97·3–98·6) for an AZD1222 booster. ....

Our results suggest that a homologous or heterologous booster dose for individuals with a complete primary vaccination schedule with CoronaVac provides a high level of protection against COVID-19, including severe disease and death. Heterologous boosters showed higher vaccine effectiveness than a homologous booster for all outcomes, providing additional support for a mix-and-match approach. ....

We assessed vaccine effectiveness against symptomatic COVID-19 and COVID-19 outcomes (hospitalisation, admission to the intensive care unit, and death) between treated individuals (three doses) and non-treated individuals (unvaccinated), adjusting for known demographic, socioeconomic, and clinical confounders by inverse probability of treatment weighting. We found that a homologous or heterologous booster dose significantly increased vaccine effectiveness against COVID-19 and COVID-19 outcomes.

Compared with no vaccination, the adjusted vaccine effectiveness with a homologous booster was 78·8% against laboratory-confirmed COVID-19, 86·3% against hospitalisation, 92·2% against ICU admission, and 86·7% against death. The adjusted vaccine effectiveness with a heterologous BNT162b2 booster dose was 96·5% against COVID-19, 96·1% against hospitalisation, 96·2% against ICU admission, and 96·8% against death. Effectiveness with an AZD1222 booster dose was 93·2% against COVID-19, 97·7% against hospitalisation, 98·9% against ICU admission, and 98·1% against death. 

View the study here:
https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(22)00112-7/fulltext